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Nicotinic Acetylcholine Receptor Agonist

Transdermal nicotine patch for Parkinson's Disease (NIC-PD Trial)

Phase 2
Waitlist Available
Led By Wolfgang Oertel, MD
Research Sponsored by James BOYD MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 60
Awards & highlights

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).

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary endpoint is calculated as the difference between the nicotine arm and the placebo arm in the change in total UPDRS I-III score between baseline and 60 weeks (14 months) (52 weeks treatment plus 8 weeks wash-out).

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transdermal nicotine patchExperimental Treatment1 Intervention
Subjects will apply a combination of 7 or 14 mg nicotine transdermal patches until reaching their highest well tolerated dose of 7 to 28 mg/day.
Group II: Transdermal placebo patchPlacebo Group1 Intervention
Subjects will apply a combination of 7 or 14 mg placebo transdermal patches until reaching their highest well tolerated dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Find a Location

Who is running the clinical trial?

Michael J. Fox Foundation for Parkinson's ResearchOTHER
113 Previous Clinical Trials
535,019 Total Patients Enrolled
International Parkinson Fonds Germany GmbHIndustry Sponsor
1 Previous Clinical Trials
91 Total Patients Enrolled
German Parkinson Society (DPG)OTHER
~12 spots leftby Sep 2025
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