An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease.
- Conditions
- paralysis agitansshaking palsy10028037
- Registration Number
- NL-OMON52546
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Percentage of subjects with adverse events (AEs) and SAEs during the study.<br /><br>2. Percentage of subjects with AEs of special interest (AESIs) during the study<br /><br>3. Percentage of subjects with numeric grade equal to or higher than 5 and<br /><br>percentage of subjects with letter grade equal to or higher than D on the<br /><br>Infusion Site Evaluation Scale at any time during the study<br /><br>4. Change in clinical laboratory test data from Baseline to the end of study<br /><br>5. Change in vital sign measurements from Baseline to the end of study<br /><br>6. Change in electrocardiograms (ECGs) from Baseline to the end of study</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change from Baseline to the end of study for the following:<br /><br>1. Average normalized daily Off time and On times as assessed by the PD<br /><br>Diary<br /><br>2. PD symptoms as assessed by the Movement Disorder Society-Unified Parkinson's<br /><br>Disease Rating Scale (MDS-UPDRS) Parts I - IV<br /><br>3. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)4.<br /><br>Health-related quality of life as assessed by the EuroQol 5-dimensions<br /><br>questionnaire (EQ-5D-5L)<br /><br>5. Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE)</p><br>