JPRN-jRCT2080224809CompletedPhase 3
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease [M15-741]
AbbVie G.K0 sites13 target enrollmentStarted: July 30, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 13
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 30age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Subjects with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa -responsive
- •- Subjects must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable Off and On states (motor fluctuations), and have a minimum of 2.5 hours of Off time per day
Exclusion Criteria
- •- Subject is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study.
- •- Subject is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.
Investigators
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Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersParkinson's DiseaseEUCTR2018-002144-85-BEAbbVie Deutschland240
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