Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
Conditions
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects completing 12 weeks treatment in Study M12-921 who would benefit from long-term treatment from ABT-SLV187. Alternatively, subjects who (i) participated in the Phase 2 Study M12-925 (ii) would, in the opinion of the Investigator, benefit from ABT-SLV187 treatment in the Study M12-923, (iii) did not discontinue the M12-925 Study due to safety reason, and (iv) meet all entry requirements. 2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
Exclusion criteria
Exclusion criteria: 1.Subject is enrolled in another clinical trial. 2. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study. 3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant and in the opinion of the PI, would be a contraindication to continued levodopa therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment-emergent adverse events, clinical labs, vital signs, ECGs Clinical Global Impression of Change(CGI-C), Patient Global Impression of Change(PGI-C), Unified Parkinson's Disease Rating Scale (UPDR S), Parkinson's Disease Questionnaire-39(PDQ-39) | — |
Outcome results
None listed