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An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004
The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).
Details
| Lead sponsor | Intec Pharma Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 460 |
| Start date | 2016-07 |
| Completion | 2019-12 |
Conditions
- Parkinson's Disease
Interventions
- Accordion Pill™ Carbidopa/Levodopa
Primary outcomes
- Unified Parkinson's Disease Rating Scale (UPDRS) — base line ( week 1) to end of study ( week 53)
Change from Baseline to End of Study (Week 53) in Parts I-IV
Countries
United States, Bulgaria, Germany, Israel, Italy, Poland, Slovakia, Spain, Ukraine, United Kingdom