A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease

This study has been completed.

First Received: October 24, 2005 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00243971

Purpose

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

Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.

The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.

Condition	Intervention	Phase
Parkinson's Disease	Drug: SPM 962	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease Sleep Disorders

Drug Information available for: Ropinirole hydrochloride Ropinirole Rotigotine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Study Start Date:	November 2004
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Early-stage, idiopathic Parkinson's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243971

Locations

Germany
Schwarz
Monheim, Germany

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SP825
Study First Received:	October 24, 2005
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00243971 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:

EARLY-STAGE, IDIOPATHIC PARKINSON'S DISEASE

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Sleep Disorders
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Signs and Symptoms
Parkinson Disease
Movement Disorders
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents
N 0437

ClinicalTrials.gov processed this record on November 27, 2009