Status:
COMPLETED
Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Abbott Japan Co.,Ltd
Conditions:
Advanced Parkinson's Disease
Eligibility:
All Genders
30-99 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01479127
Start Date
October 1 2011
End Date
July 1 2012
Last Update
April 21 2016
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