Status:
COMPLETED
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
Lead Sponsor:
UCB Pharma
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 ...
Eligibility Criteria
Inclusion
- Idiopathic restless legs syndrome
Exclusion
- Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
- Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent.
- Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT00263068
Start Date
December 1 2005
End Date
December 1 2007
Last Update
September 25 2014
Active Locations (1)
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1
Schwarz
RTP, North Carolina, United States