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Nicotinic Acetylcholine Receptor Agonist
Disease-modifying Potential of Transdermal NICotine in Early 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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 60
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).
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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
115 Previous Clinical Trials
537,113 Total Patients Enrolled
International Parkinson Fonds Germany GmbHIndustry Sponsor
1 Previous Clinical Trials
91 Total Patients Enrolled
German Parkinson Society (DPG)OTHER
Parkinson Study Group (PSG)UNKNOWN
German Parkinson Study Group (GPS)OTHER
7 Previous Clinical Trials
690 Total Patients Enrolled
Philipps University Marburg Medical CenterOTHER
151 Previous Clinical Trials
254,014 Total Patients Enrolled
Philipps University MarburgOTHER
151 Previous Clinical Trials
254,014 Total Patients Enrolled
James BOYD MDLead Sponsor
Wolfgang Oertel, MDPrincipal InvestigatorPhilipps-University Marburg, Germany / Global and German Principal Investigator
James Boyd, MDPrincipal InvestigatorUniversity of Vermont / United States Principal Investigator
1 Previous Clinical Trials
20 Total Patients Enrolled