Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced Parkinson's disease (PD) patients with severe motor complications. The complications of medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be investigated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborator: Abbott Japan Co.,Ltd
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa; Silicon

Criteria

Inclusion Criteria:

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

• PD stage corresponds to 4 or 5 in the 'off' state according to the modified Hoehn & Yahr (H & Y) classification of disease severity

• Levodopa-responsive subjects demonstrate some identifiable 'ON response' established by observation by Investigator and demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

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

• Subjects with any neurological deficit that may interfere with the study assessments