E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objectives of this study are to assess the local and systemic safety and tolerability of continued ABBV-951 treatment delivered as a CSCI for 24 hours daily and to assess the safety and tolerability of the
delivery system for ABBV-951. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must be able to understand the nature of the study and have had the opportunity to have any questions answered by the investigator.
2. Subject, if judged by the investigator to have decision making capacity, must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to initiation of any study-specific procedures.
3. Subject completed ABBV-951 Study M15-741 (parent study) and remained on study drug.
4. Subject is willing and able to comply with procedures required in this protocol.
5. Subject is not considered by the investigator to be an unsuitable candidate to continue to receive ABBV-951 for any reason.
6. Subject does not currently exhibit significant suicidal behavior (suicidal behavior is evidenced by answering "yes" to any question on the suicidal behavior portion of the C-SSRS) or suicidal ideation (suicidal ideation is evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS) at the Final Visit of the parent study. Subjects who exhibit suicidality during the course of the parent study prior to the Final Visit are eligible based on the Investigator's judgment.
7. If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least 1 protocol-specified method of birth control that is effective from D1 through at least 30 days after the end of the infusion of study drug. Subject is not pregnant, breastfeeding, or considering becoming pregnant or donating eggs during the study or within 30 days after the end of the infusion of study drug. If female of childbearing potential, subject must have a negative urine pregnancy test on D1.
8. If male and sexually active with a female partner(s) of childbearing potential, subject must agree to practice protocol-specified contraception. Subject is not considering fathering a child or donating sperm during the study or within 30 days after the end of the infusion of study drug. |
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E.4 | Principal exclusion criteria |
1. Subject has received an investigational product other than ABBV-951 within a time period equal to 5 half-lives, if known, or within 6 weeks, whichever is longer, prior to study drug administration. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of subjects with AEs and SAEs during the study
2. Percentage of subjects with AEs of special interest (AESIs) during the study
3. Percentage of subjects with numeric grade equal to or higher than 5 and percentage of subjects with letter grade equal to or higher than D on the Infusion Site Evaluation Scale at any time during the study
4. Percentage of subjects with AEs and SAEs associated with product complaints related to the Neria Guard infusion set during the study
5. The number of product complaints associated with the Neria Guard infusion set that resulted in the subject replacing the infusion set
6. Percentage of subjects with AEs and SAEs associated with pump-specific product complaints
7. The percentage of pumps that were replaced due to pump malfunction
8. The number of events where subjects were required to take rescue medication due to a pump malfunction
9. Change in clinical laboratory test data from Baseline to the end of study
10. Change in vital sign measurements from Baseline to the end of study
11. Change in electrocardiograms (ECGs) from Baseline to the end of study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. At each remote assessment and clinic visit.
2. At each remote assessment and clinic visit
3. Collected at each clinic visit
4. Collected at each clinic visit
5. Collected at each clinic visit
6. Collected at each clinic visit |
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E.5.2 | Secondary end point(s) |
Change from Baseline to the end of study for the following:
1. Average normalized daily "Off" time and "On" times as assessed by the PD Diary
2. PD symptoms as assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I - IV
3. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)
4. Health-related quality of life as assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L)
5. Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary endpoints are collected at each clinic visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Japan |
Russian Federation |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end-of-study is defined as the date of the last subject's last visit or date of the last follow-up contact, whichever is later. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 18 |