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Nicotinic Acetylcholine Receptor Agonist

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

Phase 2
Waitlist Available
Led By James Boyd, 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 baseline to week 52 and week 60
Awards & highlights

NIC-PD Trial 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

NIC-PD Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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).
Secondary outcome measures
BDI-II that is calculated as the change between baseline and 60 weeks
Beck Depression Inventory - II (BDI-II) that is calculated as the change between baseline and week 52
Determine whether the slope of the curves for the total UPDRS score in active- and placebo-treated subjects show a tendency to converge over time
+9 more

NIC-PD 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?

International Parkinson Fonds Germany GmbHIndustry Sponsor
1 Previous Clinical Trials
91 Total Patients Enrolled
Philipps University Marburg Medical CenterOTHER
145 Previous Clinical Trials
253,837 Total Patients Enrolled
Michael J. Fox Foundation for Parkinson's ResearchOTHER
112 Previous Clinical Trials
534,996 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease
James BOYD MD 2012. "Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01560754.
All > Parkinson
~13 spots leftby Apr 2025
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