Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease

Phase 2 Unknown 160 enrolled James BOYD MD German Parkinson Society (DPG) · collab German Parkinson Study Group (GPS) · collab International Parkinson Fonds Germany GmbH · collab Michael J. Fox Foundation for Parkinson's Research · collab Parkinson Study Group (PSG) · collab Philipps 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

Outcome

Missed primary endpoint

paper One-year transdermal nicotine treatment did not slow progression in early Parkinson’s disease. PMID 38320207 ↗

paper HL-difference with 95% CI: –3 [–6 to 0], P=0.06. PMID 38320207 ↗

Publications

Oertel WH, Muller HH, Unger MM, Schade-Brittinger C, Balthasar K, Articus K, Brinkman M, Venuto CS, Tracik F, Eberling J, Eggert KM, Kamp C, Kieburtz K, Boyd JT. Transdermal Nicotine Treatment and Progression of Early Parkinson's Disease. NEJM Evid. 2023 Sep;2(9):EVIDoa2200311. doi: 10.1056/EVIDoa2200311. Epub 2023 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nicotine	Unknown	7 mg	Other
Subject	Nicotine	Unknown	14 mg	Other