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A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease

NCT00243945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-09-25

No results posted yet for this study

Summary

The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD.

Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study.

The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed

Conditions

  • IDIOPATHIC PARKINSON'S DISEASE

Interventions

DRUG

Rotigotine

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · UCB Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • Germany

Study Locations

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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 NCT00243945 on ClinicalTrials.gov