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

Study Identifier
M12-925
CT.gov Identifier
NCT01479127
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
  • ABT-SLV187
  • Oral Levodopa/Carbidopa
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    30 - 99 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    No locations found.