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CompletedNCT00242008Updated Sep 25, 2014

A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease

A Phase 3 interventional study of Rotigotine in Parkinson's Disease, sponsored by UCB Pharma. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-25.

Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.

Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial.

The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • IDIOPATHIC PARKINSON'S DISEASE
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  • Idiopathic Parkinson's disease

Exclusion criteria

Exclusion Criteria:

  • Not taking a dopamine agonist
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugRotigotine
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What researchers measure

Primary outcomes

  1. Tolerability of rotigotine as determined by the total number of subjects completing the trial.

  2. Effect on symptoms and other variables.

  3. Safety.

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Study locations

1 site
  • Schwarz
    RTP, North Carolina, United States
08

References and documents

Publications

  • LeWitt PA, Boroojerdi B, MacMahon D, Patton J, Jankovic J. Overnight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease. Clin Neuropharmacol. 2007 Sep-Oct;30(5):256-65. doi: 10.1097/wnf.0b013e318154c7c4. PubMed 17909303 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00242008
Lead sponsor
UCB Pharma
First posted
Oct 19, 2005
Start date
Dec 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Sep 25, 2014

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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