EUCTR2018-002144-85-NLActive, not recruitingPhase 1
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 - Galliarde
AbbVie Deutschland0 sites130 target enrollmentStarted: March 27, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 65
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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
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-DEAbbVie Deutschland240
Completed
Phase 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 diseaseNL-OMON55829AbbVie Deutschland GmbH & Co. KG6
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyParkinson's DiseaseEUCTR2018-002144-85-DKAbbVie Deutschland240
Active, not recruiting
Phase 1
Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyMedDRA version: 21.1Level: PTClassification code 10068100Term: Vascular parkinsonismSystem Organ Class: 10029205 - Nervous system disordersParkinson's DiseaseEUCTR2018-002144-85-ITABBVIE DEUTSCHLAND GMBH & CO. KG130
