drugset / Trial / NCT01560754
Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease
Phase 2
Unknown
160 enrolled
James BOYD MD
German Parkinson Society (DPG) · collabGerman Parkinson Study Group (GPS) · collabInternational Parkinson Fonds Germany GmbH · collabMichael J. Fox Foundation for Parkinson's Research · collabParkinson Study Group (PSG) · collabPhilipps University Marburg · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objective of this study is to demonstrate that transdermal nicotine treatment retards disease progression as measured by change in total Unified Parkinson's Disease Rating Scale (UPDRS)(part I, II, III)score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).
Timeline
- Start
- 2012-10
- Primary completion
- 2016-08
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 7 mg | Other |
| Subject | Nicotine | Unknown | 14 mg | Other |