Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborator: Quintiles, Inc.
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria:

• Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria

• Levodopa-responsive with severe motor fluctuations

• Recognizable off and on state (motor fluctuations) confirmed by diary

Exclusion Criteria:

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism

• Undergone surgery for the treatment of PD

• Contraindications to levodopa (such as narrow angle glaucoma)