To assess the local and systemic safety and tolerability of continued ABBV-951 treatment delivered as a CSCI for 24 hours daily.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Percentage of subjects with adverse events (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. Change in clinical laboratory test data from Baseline to the end of study
5. Change in vital sign measurements from Baseline to the end of study
6. Change in electrocardiograms (ECGs) from Baseline to the end of study
Secondary outcome
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)
Background summary
Parkinson's disease (PD) is a neurological condition, which affects the brain.
PD gets worse over time, but how quickly it progresses varies a lot from person
to person. Some symptoms of PD are tremors, stiffness, and slowness of
movement.
Study objective
To assess the local and systemic safety and tolerability of continued ABBV-951
treatment delivered as a CSCI for 24 hours daily.
Study design
Open-label, single arm, extension study
Intervention
Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951
for 24 hours daily for 96 weeks or until premature discontinuation.
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care. Participants will attend regular clinic visits and
remote assessments during the course of the study at a hospital or clinic. The
effect of the treatment will be checked by medical
assessments, blood tests, checking for side effects, and completing
questionnaires.
Knolsstrasse 70
Ludwigshafen 67061
DE
Knolsstrasse 70
Ludwigshafen 67061
DE
Listed location countries
Age
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.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004235-23-NL |
| ClinicalTrials.gov | NCT04379050 |
| CCMO | NL73757.028.20 |