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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

NCT00599196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2014-10-02

Study results available
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Summary

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

Conditions

  • Early Stage Parkinson's Disease

Interventions

DRUG

Rotigotine

Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours. After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Australia
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00599196 on ClinicalTrials.gov