MedTrace Logo

Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

NCT00522379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2014-10-27

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Conditions

Interventions

DRUG

Rotigotine

2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

DRUG

Rotigotine

4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

OTHER

Placebo

Placebo transdermal patch applied daily

DRUG

Rotigotine

6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

DRUG

Rotigotine

8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Chile
  • India
  • Mexico
  • Peru

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 NCT00522379 on ClinicalTrials.gov