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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ROTIGOTINE

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Clinical Trials for Rotigotine

Trial ID Title Status Sponsor Phase Summary
NCT00135993 Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome Completed UCB Pharma Phase 3 Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
NCT00136045 Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome Completed UCB Pharma Phase 3 The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives are to investigate the safety and tolerability of rotigotine. The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI) Item 1 (severity of illness) score at the end of the Maintenance Period. Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this trial, participating at approximately 50 sites. The maximum duration of the trial is approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial. Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of rotigotine.
NCT00242008 A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease Completed UCB Pharma Phase 3 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.
NCT00243217 Rotigotine Restless Legs Syndrome Dose Finding Trial Completed UCB Pharma Phase 2 The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rotigotine

Condition Name

Condition Name for Rotigotine
Intervention Trials
Parkinson's Disease 21
Restless Legs Syndrome 13
IDIOPATHIC PARKINSON'S DISEASE 8
Healthy 5
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Condition MeSH

Condition MeSH for Rotigotine
Intervention Trials
Parkinson Disease 42
Syndrome 19
Restless Legs Syndrome 18
Psychomotor Agitation 18
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Clinical Trial Locations for Rotigotine

Trials by Country

Trials by Country for Rotigotine
Location Trials
United States 232
Germany 28
Italy 15
Austria 9
Spain 9
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Trials by US State

Trials by US State for Rotigotine
Location Trials
Florida 21
North Carolina 16
California 13
Texas 12
New York 12
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Clinical Trial Progress for Rotigotine

Clinical Trial Phase

Clinical Trial Phase for Rotigotine
Clinical Trial Phase Trials
Phase 4 11
Phase 3 27
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Rotigotine
Clinical Trial Phase Trials
Completed 59
Recruiting 7
Terminated 3
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Clinical Trial Sponsors for Rotigotine

Sponsor Name

Sponsor Name for Rotigotine
Sponsor Trials
UCB Pharma 40
UCB BIOSCIENCES GmbH 9
Otsuka Pharmaceutical Co., Ltd. 8
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Sponsor Type

Sponsor Type for Rotigotine
Sponsor Trials
Industry 68
Other 17
NIH 1
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