Clinical Trial Results:
An Open-Label Extension Study Of The Safety And Clinical Utility Of IPX203 In Parkinson’s Disease Patients With Motor Fluctuations
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Summary
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EudraCT number |
2018-002234-21 |
Trial protocol |
DE CZ ES GB PL IT |
Global end of trial date |
21 Mar 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jul 2023
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First version publication date |
01 Jul 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
IPX203-B16-03
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03877510 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Impax Laboratories, LLC
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Sponsor organisation address |
400 Crossing Boulevard, Third Floor, Bridgewater, NJ, United States, 08807
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Public contact |
Pamela Fitzpatrick, Impax Laboratories, LLC, +1 631-633-2104, pfitzpatrick@amneal.com
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Scientific contact |
Pamela Fitzpatrick, Impax Laboratories, LLC, +1 631-633-2104, pfitzpatrick@amneal.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Mar 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Mar 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the long-term safety and clinical utility of IPX203 in the treatment of subjects with advanced Parkinson’s disease (PD) who have motor fluctuations.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Apr 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 209
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Country: Number of subjects enrolled |
Czechia: 28
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Country: Number of subjects enrolled |
France: 10
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Country: Number of subjects enrolled |
Germany: 30
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Country: Number of subjects enrolled |
Italy: 27
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Country: Number of subjects enrolled |
Poland: 66
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Country: Number of subjects enrolled |
Spain: 39
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Country: Number of subjects enrolled |
United Kingdom: 10
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Worldwide total number of subjects |
419
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EEA total number of subjects |
200
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
152
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From 65 to 84 years |
264
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85 years and over |
3
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Recruitment
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Recruitment details |
Subjects took part in the study at 94 sites across the United States, Italy, Spain, France, United Kingdom, Czech Republic, Poland, and Germany. | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
The study IPX203-B16-03 was a 9-month, open-label extension of study IPX203-B16-02. Subjects who had successfully completed Study IPX203-B16-02 had opportunity to enroll in this open-label study. A total of 419 subjects enrolled from study IPX203-B16-02, 206 subjects from the previous IPX203 group and 213 subjects from the previous IR-CD-LD group. | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||
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Arms
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Arm title
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IPX203 | ||||||||||||||||||||||
Arm description |
IPX203 carbidopa-levodopa (CD-LD) extended-release (ER) capsules, orally in 4 different dose strength (35-140 mg, 52.5-210 mg, 70-280 mg, 87.5-350 mg) as per Investigator's discretion. | ||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||
Investigational medicinal product name |
IPX203 CD-LD ER Capsules
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
IPX203 (carbidopa-levodopa) ER capsules orally in 4 different dose strength (35-140 mg, 52.5-210 mg, 70-280 mg, 87.5-350 mg) as per Investigator's discretion.
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Baseline characteristics reporting groups
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Reporting group title |
IPX203
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Reporting group description |
IPX203 carbidopa-levodopa (CD-LD) extended-release (ER) capsules, orally in 4 different dose strength (35-140 mg, 52.5-210 mg, 70-280 mg, 87.5-350 mg) as per Investigator's discretion. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IPX203
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Reporting group description |
IPX203 carbidopa-levodopa (CD-LD) extended-release (ER) capsules, orally in 4 different dose strength (35-140 mg, 52.5-210 mg, 70-280 mg, 87.5-350 mg) as per Investigator's discretion. | ||
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End point title |
Number of Subjects with Treatment-emergent Adverse Events (TEAEs) [1] | ||||||
End point description |
An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug. The safety analysis set included all subjects who were treated with the open-label study drug in the study.
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End point type |
Primary
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End point timeframe |
From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Planned analyses for these data was descriptive only. |
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| No statistical analyses for this end point | |||||||
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End point title |
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I Score | ||||||||||||||||
End point description |
MDS-UPDRS was a multimodal scale assessing impairment and disability. Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the subject and caregivers. Component IB is completed by the subject with or without help from the caregiver but independent of the investigator. Overall, there are 13 questions rated from 0 - normal to 4- severe. Total score ranges from 0 to 52. with higher scores reflecting greater severity. The Intent-to-treat analysis set (ITT) included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category. ET stands for early termination.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II Score | ||||||||||||||||
End point description |
Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) was a self-administered questionnaire overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52., with a lower score indicating better motor function for daily living and higher score indicating more severe motor symptoms. The ITT included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV Score | ||||||||||||||||
End point description |
Part 4 of the MDS-UPDRS objectively measures the disability associated with levodopa-induced dyskinesia. Disability was assessed via video analysis by unbiased blinded central raters. Disability was evaluated for communication, drinking from a cup, and ambulation items. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24. A higher score indicated more severe symptoms. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III Score | ||||||||||||||||
End point description |
Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6, and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III Score | ||||||||||||||||
End point description |
Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 normal to 4 severe. Total score ranges from 0 to 132. Total score ranges from 0 (no symptom) to 184 (severe symptoms), higher score indicated more severe symptoms. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6, and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score | ||||||||||||||||
End point description |
Measure of MDS-UPDRS - sum total of 4 parts.Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components.Component IA contains a number of behaviors assessed by investigator.Component IB is completed by subject.Overall, there are 13 questions rated from 0 normal to 4 severe.Total score ranges from 0 to 52, higher score more severe symptoms.Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire.13 questions rated from 0 normal to 4 severe.Total score ranges from 0 to 52. Part III: Motor Examination assesses motor signs of PD; completed by rater. 33 questions rated from 0 normal to 4 severe.Total score ranges 0 to 132 Part IV: Motor Complications; completed by rater. 6 questions rated from 0 normal to 4 severe.Total score ranges from 0 to 24.Overall sum ranges from 0-260. ITT set was used.Here “N” are subjects who were evaluable for outcome measure; "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Clinical Global Impression of Severity (CGI-S) Score | ||||||||||||||||
End point description |
The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, subjects were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Patient Global Impression of Severity (PGI-S) Score | ||||||||||||||||
End point description |
The PGI-S was a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill. Higher value indicates increased improvement. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
39-item Parkinson’s Disease Questionnaire (PDQ-39) Total Score | ||||||||||||||||
End point description |
The PDQ-39 was a disease-specific instrument designed to measure aspects of health that were relevant to subjects with PD, and which may not be included in general health status questionnaires. It evaluated the 8 domains using 39-items of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Total scores were calculated for the entire questionnaire and each domain. The full range of the PDQ-39 Summary Index score is from 0 (no subject-related symptoms/quality of life unaffected) to 100 (highest subject-related symptoms/low quality of life). The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Parkinson Anxiety Scale (PAS) Total Score | ||||||||||||||||
End point description |
PAS was 12-item subject or observer rated questionnaire with 3 domains: persistent anxiety measured by 5 questions (Each question ranged from 0 not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20., episodic anxiety measured by 4 questions (Each question ranged from 0 never to 4 nearly always. Best score is 0; worst score is 16. and avoidance anxiety measured by 3 questions (Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16). Total score is the sum of the 12 item scores, with a range of 0 to 48; a lower value is desirable. Total score was calculated for the entire questionnaire and each domain. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment.Here “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD) Total Score | ||||||||||||||||
End point description |
The NMSS is a 9 domain (cardiovascular, sleep/fatigue, mood/cognition, perceptual problems, attention/memory, gastrointestinal, urinary, sexual function, and miscellaneous) 30 question scale rating symptom severity on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score. Total scores were calculated for the entire questionnaire and each domain. Zero is the best score and 360 is the worst score. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Parkinson’s Disease Sleep Scale-2 (PDSS-2) Total Score | ||||||||||||||||
End point description |
PDSS-2 was a 15-item self-reported questionnaire. Three domains are defined: disturbed sleep, motor symptoms at night, PD symptoms at night. Total score was calculated for the entire questionnaire and each domain. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects with Treatment Satisfaction Assessment (TSA) Scores 5-7 (Satisfied) versus Scores 1-4 (Dissatisfied or Neutral) | ||||||||||||||||||||
End point description |
The TSA was a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied. The responses were as follows: 1= Very much dissatisfied, 2 = Very dissatisfied, 3 = Somewhat dissatisfied, 4 = Neither satisfied nor dissatisfied, 5 = Somewhat satisfied, 6 = Very satisfied, 7 = Very much satisfied. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
TSA Score | ||||||||||||||
End point description |
The TSA was a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied. The responses were as follows: 1= Very much dissatisfied, 2 = Very dissatisfied, 3 = Somewhat dissatisfied, 4 = Neither satisfied nor dissatisfied, 5 = Somewhat satisfied, 6 = Very satisfied, 7 = Very much satisfied. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Month 3, Month 6 and Month 9
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change From Baseline in MDS-UPDRS: Part I Score | ||||||||||||
End point description |
MDS-UPDRS was a multimodal scale assessing impairment and disability. Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the subject and caregivers. Component IB is completed by the subject with or without help from the caregiver but independent of the investigator. Overall there are 13 questions rated from 0 - normal to 4- severe. Total score ranges from 0 to 52. with higher scores reflecting greater severity. The ITT included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in MDS-UPDRS: Total Score | ||||||||||||
End point description |
Measure of MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components.Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the subject. Overall, there are 13 questions rated from 0 normal to 4 severe.Total score ranges from 0 to 52. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 normal to 4 severe.Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 normal to 4 severe.Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.Overall sum ranges from 0-260. ITT set was used. Here “N” are the subjects who were evaluable for the outcome measure; "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in MDS-UPDRS: Part III Score | ||||||||||||
End point description |
Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132., with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in MDS-UPDRS: Part II Score | ||||||||||||
End point description |
Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) was a self-administered questionnaire overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52., with a lower score indicating better motor function for daily living and higher score indicating more severe motor symptoms. The ITT included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in MDS-UPDRS: Part IV Score | ||||||||||||
End point description |
Part 4 of the MDS-UPDRS objectively measures the disability associated with levodopa-induced dyskinesia. Disability was assessed via video analysis by unbiased blinded central raters. Disability was evaluated for communication, drinking from a cup, and ambulation items. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24. A higher score indicated more severe symptoms. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
|
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in MDS-UPDRS: Sums of Part II and Part III Score | ||||||||||||
End point description |
Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52. Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 normal to 4 severe. Total score ranges from 0 to 132. Total score ranges from 0 to 184. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
|
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects With a PGI-S >= 4 and PGI-S >= 5 Score | ||||||||||||||||||||||||
End point description |
The PGI-S was a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill. Higher value indicates increased improvement. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 3, Month 6, and Month 9
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in PGI-S Score | ||||||||||||
End point description |
The PGI-S was a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill. Higher value indicates increased improvement. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
|
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects With a CGI-S >= 4 and CGI-S >= 5 Score | ||||||||||||||||||||||||
End point description |
The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, subjects were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline and Month 9/ET
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in CGI-S Score | ||||||||||||
End point description |
The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, subjects were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category. Negative score= not ill.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in NMSS for Parkinson's Disease (PD) Total Score | ||||||||||||
End point description |
The NMSS is a 9 domain (cardiovascular, sleep/fatigue, mood/cognition, perceptual problems, attention/memory, gastrointestinal, urinary, sexual function, and miscellaneous) 30 question scale rating symptom severity on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score. Total scores were calculated for the entire questionnaire and each domain. Zero is the best score and 360 is the worst score. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in PAS: Total Score | ||||||||||||
End point description |
PAS was 12-item subject or observer rated questionnaire with 3 domains: persistent anxiety measured by 5 questions (Each question ranged from 0 not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20., episodic anxiety measured by 4 questions (Each question ranged from 0 never to 4 nearly always. Best score is 0; worst score is 16. and avoidance anxiety measured by 3 questions (Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16). Total score is the sum of the 12 item scores, with a range of 0 to 48; a lower value is desirable. Total score was calculated for the entire questionnaire and each domain. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are subjects who were evaluable for outcome measure; "n" signifies subjects who were evaluable for each specified category.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in PDQ-39 Total Score | ||||||||||||
End point description |
The PDQ-39 was a disease-specific instrument designed to measure aspects of health that were relevant to subjects with PD, and which may not be included in general health status questionnaires. It evaluated the 8 domains using 39-items of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Total scores was calculated for the entire questionnaire and each domain. The full range of the PDQ-39 Summary Index score is from 0 (no subject-related symptoms/quality of life unaffected) to 100 (highest subject-related symptoms/low quality of life). The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
|
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End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in PDSS-2: Total Score | ||||||||||||
End point description |
PDSS-2 was a 15-item self-reported questionnaire. Three domains are defined: disturbed sleep, motor symptoms at night, PD symptoms at night. Total score was calculated for the entire questionnaire and each domain. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. The ITT set included all subjects who were treated with the open-label study drug in the study and have at least one post-baseline clinical utility assessment. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure and "n" signifies subjects who were evaluable for each specified category.
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End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Month 9
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
IPX203
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Reporting group description |
IPX203 CD-LD ER capsules, orally in 4 different dose strength (140 mg, 210 mg, 280 mg and 350 mg) as per Investigator's discretion. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 Jun 2018 |
Protocol Amendment 1: Clarified the following text with regard to EMSQ (Appendix N): If you experienced any symptom in the question (Q.1) above on at least one day over the past week, indicate for this symptom (or for these symptoms) the severity to which this symptom impaired your morning activities and social interactions using the severity definitions below. Which of the early morning symptoms (if any) that you identified above and assessed severity in Q.2 above improved after taking a first morning dose of your Parkinson’s medication(s)? For each symptom indicate “YES” improved, or “NO” did not improve. If you did not experience the symptom (i.e., answered 0 to Q.1 above), indicate “Did not experience”. |
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26 Nov 2018 |
Protocol Amendment 2: Updated measures and/or instruments used in the study to the most current versions available for licensing; Clarified text in Sections 4, 7, 8.1 and Table 2; Updated storage information for consistency; Removed the C-SSRS Baseline/Screening Version. Only the C-SSRS Since Last Visit Version was required for this open-label extension study since subjects were continuing from Study IPX203-B16-02. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
