NCT00243971

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2009

Enrollment Period

11 months

First QC Date

October 24, 2005

Last Update Submit

September 24, 2014

Conditions

Parkinson's Disease

Keywords

EARLY-STAGE, IDIOPATHIC PARKINSON'S DISEASE

Interventions

SPM 962DRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early-stage, idiopathic Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schwarz

Monheim, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 25, 2005

Study Start

November 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

September 25, 2014

Record last verified: 2009-09

Locations

DE(1)