Clinical Trial Results:
Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram
Summary
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EudraCT number |
2007-004009-93 |
Trial protocol |
IT |
Global end of trial date |
23 Jul 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2017
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First version publication date |
05 Jan 2017
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Other versions |
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 |
12118A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Lundbeck Italy
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Sponsor organisation address |
Via della Moscova 3, Milano , Italy, 20121
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Public contact |
LundbeckClinicalTrials@lundbeck.com, LUNDBECK ITALIA SpA, LundbeckClinicalTrials@lundbeck.com
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Scientific contact |
LundbeckClinicalTrials@lundbeck.com, LUNDBECK ITALIA SpA, LundbeckClinicalTrials@lundbeck.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 |
23 Jul 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Jul 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jul 2010
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of the present study is to evaluate the efficacy and safety of escitalopram 10-20 mg/day in depression, anxiety or impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease (efficacy objective)
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Nov 2008
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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 |
Italy: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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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) |
8
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Parkinson patients with depression symptoms | ||||||||||||||||||||||||
Arm description |
Study duration per patient was 6 months as per treatment period. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Escitalopram
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Starting dose: 5 mg/day for 1 week. Dose adjustment was allowed starting from the first visit (1.5 month after treatment start) with possible increase up to 20 mg/day according to clinical needs. Flexible doses 10-20 mg/day were allowed from visit 1 to the end of treatment.
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Arm title
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Parkinson patients with anxiety symptoms | ||||||||||||||||||||||||
Arm description |
Study duration per patient was 6 months as per treatment period. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Escitalopram
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Starting dose: 5 mg/day for 1 week. Dose adjustment was allowed starting from the first visit (1.5 month after treatment start) with possible increase up to 20 mg/day according to clinical needs. Flexible doses 10-20 mg/day were allowed from visit 1 to the end of treatment.
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Arm title
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Parkinson patients with impulse control symptoms | ||||||||||||||||||||||||
Arm description |
Study duration per patient was 6 months as per treatment period. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Escitalopram
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Starting dose: 5 mg/day for 1 week. Dose adjustment was allowed starting from the first visit (1.5 month after treatment start) with possible increase up to 20 mg/day according to clinical needs. Flexible doses 10-20 mg/day were allowed from visit 1 to the end of treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Parkinson patients with depression symptoms
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Depression symptoms in patients suffering from Parkinson disease
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Subject analysis set title |
Parkinson patients with anxiety symptoms
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Anxiety symptoms in patients suffering from Parkinson disease
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Subject analysis set title |
Parkinson patients with impulse control disorder symptoms
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease
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End points reporting groups
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Reporting group title |
Parkinson patients with depression symptoms
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Reporting group description |
Study duration per patient was 6 months as per treatment period. | ||
Reporting group title |
Parkinson patients with anxiety symptoms
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Reporting group description |
Study duration per patient was 6 months as per treatment period. | ||
Reporting group title |
Parkinson patients with impulse control symptoms
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Reporting group description |
Study duration per patient was 6 months as per treatment period. | ||
Subject analysis set title |
Parkinson patients with depression symptoms
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Depression symptoms in patients suffering from Parkinson disease
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Subject analysis set title |
Parkinson patients with anxiety symptoms
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Anxiety symptoms in patients suffering from Parkinson disease
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Subject analysis set title |
Parkinson patients with impulse control disorder symptoms
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease
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End point title |
Change from baseline in Hamilton Rating Scale for Depression (HAM-D) score [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline to end of treatment
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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: Descriptive statistics |
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No statistical analyses for this end point |
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End point title |
Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) score [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline to end of treatment
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Notes [2] - 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: Descriptive statistics |
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No statistical analyses for this end point |
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End point title |
Change from baseline in Barrat Impulsivness Scale (BIS) total score [3] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline to end of treatment
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Notes [3] - 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: Descriptive statistics |
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No statistical analyses for this end point |
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End point title |
Change from baseline in Unified Parkinson Disease Rating Scale (UPDRS) total score | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to end of treatment
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No statistical analyses for this end point |
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End point title |
Change from baseline in Visual Analogic Scale (VAS) for daily off time. | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline to end of treatment
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No statistical analyses for this end point |
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End point title |
Change from baseline in UPDRS-II (ADL) | ||||||||||||||||
End point description |
Unified Parkinson Disease Rating Scale (UPDRS)
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End point type |
Secondary
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End point timeframe |
baseline to end of treatment
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No statistical analyses for this end point |
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End point title |
Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39) | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
baseline to end of treatment
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No statistical analyses for this end point |
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End point title |
Change from baseline in BDI; depression self evaluation | ||||||||||||||||
End point description |
Beck Depression Inventory (BDI); depression self evaluation
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End point type |
Secondary
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End point timeframe |
baseline to end of treatment
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No statistical analyses for this end point |
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End point title |
Change from baseline in Symptom Check List-90 (SCL-90) compulsive behaviour – self evaluation | ||||||||||||||||
End point description |
Symptom Check List-90 (SCL-90); compulsive behavior – self evaluation
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End point type |
Secondary
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End point timeframe |
baseline to end of treatment
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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 baseline to end of treatment
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Parkinson patients witn depression symptoms
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Reporting group description |
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Reporting group title |
Parkinson patients with anxiety symptoms
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Reporting group description |
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Reporting group title |
Parkinson patients with impulse control disorder symptoms
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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13 Sep 2007 |
-New title
-The Padua Inventory (PI) was been replaced by the Barrat Impulsiveness Scale (BIS) as primary efficacy parameter for ICD diagnostic group
- The PI has been replaced by BIS in the following paragraphes of the protocol
-The MINI structured interview has been introduced for diagnosis to be made |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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. | |||||||
The study was terminated and no meaningful interpretations can be made. Planned sample size was more than 200 patients |