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Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients

NCT01646268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2015-08-11

Study results available
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Summary

The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious in Chinese subjects with early-stage idiopathic Parkinson's disease.

Conditions

  • IDIOPATHIC PARKINSON'S DISEASE

Interventions

DRUG

Rotigotine

Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period

DRUG

Placebo Patch

Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · 1 877 822 9493

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • China

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 NCT01646268 on ClinicalTrials.gov