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

NCT01560754 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-09-29

No results posted yet for this study

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).

Conditions

Interventions

DRUG

nicotine transdermal patch

Transdermal patches containing 7 or 14 mg nicotine or placebo with subjects titrating up until reaching their highest tolerated dose of 7 to 28mg/day.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Parkinson Study Group (PSG)

    collaborator UNKNOWN

  • International Parkinson Fonds Germany GmbH

    collaborator INDUSTRY

  • German Parkinson Study Group (GPS)

    collaborator OTHER

  • German Parkinson Society (DPG)

    collaborator OTHER

  • Philipps University Marburg

    collaborator OTHER

  • James BOYD MD

    lead OTHER

Principal Investigators

  • Wolfgang Oertel, MD · Philipps-University Marburg, Germany / Global and German Principal Investigator

  • James Boyd, MD · University of Vermont / United States Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560754 on ClinicalTrials.gov