To assess the local and systemic safety and tolerability of ABBV-951 delivered as a CSCI for 24 hours daily for up to 52 weeks.
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 serious adverse events
(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 end of study
5. Change in vital sign measurements from Baseline to end of study
6. Change in electrocardiograms (ECGs) from Baseline to end of study
Secondary outcome
Change from Baseline to 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 (or the UPDRS Parts I-V in
countries where a validated translation of the MDS-UPDRS is not available)
3. Sleep symptoms as assessed by the PD Sleep Scale-2 (PDSS-2)
4. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)
5. Health-related quality of life as assessed by the EuroQol 5-dimensions
questionnaire (EQ-5D-5L)
Background summary
ABBV-951 is a soluble formulation of carbidopa/levodopa that is deliverable by
continuous subcutaneous infusion. ABBV-951 has the potential to achieve
efficacy similar to levodopa-carbidopa intestinal gel (LCIG) in patients with
Parkinson's disease (PD) by delivering a much smaller volume in a less invasive
approach than LCIG. This study is conducted to assess the safety and
tolerability of the long-term use of ABBV-951 in PD patients, whose motor
symptoms are inadequately controlled by their current treatment.
Study objective
To assess the local and systemic safety and tolerability of ABBV-951 delivered
as a CSCI for 24 hours daily for up to 52 weeks.
Study design
Open-label, single arm study
Intervention
ABBV-951 solution for infusion
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness (if applicable):
ABBV-951 is an investigational drug containing levodopa and carbidopa. This is
usually dosed in tablets or via intestinal gel (LCIG). ABBV-951 is a soluble
form of levodopa/carbidopa that can be distributed via subcutaneous infusion.
Risks associated with participation are risks involving study procedures and
risks associated with the study drug dispensation via subcutaneous infusion.
Side effects of ABBV-951 are comparable to side effects of levodopa/carbidopa
oral tablets or intestinal gel.
The burden for study participants exists of attending study visits, completing
disease and dosing diaries between the visits and the training for the ABBV-951
dosing system.
Knollstrasse 70
Ludwigshafen 67061
DE
Knollstrasse 70
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
Adult male or female subjects, 30 years of age or older at the time of
screening, with a diagnosis of idiopathic PD that is levodopa-responsive
Exclusion criteria
Subjects judged by the investigator to be adequately controlled by current
therapy, that don't have recognizable/identifiable "Off" and "On" states (motor
fluctuations), and have less than 2.5 hours of "Off" time per day.
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 | EUCTR2018-002144-85-NL |
| ClinicalTrials.gov | NCT03781167 |
| CCMO | NL68350.078.19 |