Status:
COMPLETED
The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore it would be im...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- diagnosis of idiopathic Restless Legs Syndrome, confirmed by a score of at least 11 on the RLS Diagnostic Index
- certain severity of symptoms (at least score of 15 on the International Restless Legs Score (IRLS)
- Have had RLS symptoms for at least 15 nights in the last four weeks.
- \< 6 hours of sleep in nights with RLS symptoms
- MADRS (depression rating scale) score of at least 12 (= borderline to depression) at baseline
- Exclusion criteria:
- any other sleep disorder that might interfere with the RLS symptoms or sleep (e.g. sleep apnea disorder, narcolepsy)
- Secondary RLS due to diagnosis of renal insufficiency, polyneuropathy, pregnancy (see below), iron deficiency anemia
- Any significant psychiatric disorders (e.g. schizophrenia, bipolar disorder); depression which by judgement of the investigator is caused by RLS, is not an exclusion criterion.
- Current or past suicidality
- medication known to trigger/aggravate/ cause or interfere with RLS symptoms (e.g. most antidepressants, lithium, neuroleptics, opioids, carbidopa, clonidine, antihistamines, anticonvulsants etc.).
- daytime RLS symptoms which require treatment (daytime: 10 a.m. until 6 p.m.).
- concomitant movement disorders (e.g. Parkinson's Disease, dyskinesia, dystonia).
- medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, rheumatoid arthritis, fibromyalgia syndrome, cancer etc.).
- Subjects taking any medication known to induce drowsiness or to affect sleep.
- Subjects who are pregnant, lactating or of childbearing potential. Women of childbearing potential must use adequate contraception
- clinically significant or unstable medical conditions (e.g. severe heart disease, severe liver or kidney disease etc.).
- pain syndromes, caused by other disorders than RLS
- excessive caffeine intake
- diastolic blood pressure \>110mmHg or \<50mmHg or systolic blood pressure \>180mmHg or \<90mmHg at baseline.
- Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) or the oral contraceptive pill (OCP) and/or certain drugs which are known to interact with ropinirole (e.g. ciprofloxacin, cimetidine, tobacco, omeprazole).
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00357097
Start Date
June 1 2006
End Date
December 1 2007
Last Update
June 7 2012
Active Locations (50)
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1
GSK Investigational Site
Ellwangen, Baden-Wurttemberg, Germany, 73479
2
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79104
3
GSK Investigational Site
Ostfildern, Baden-Wurttemberg, Germany, 73760
4
GSK Investigational Site
Ulm, Baden-Wurttemberg, Germany, 89073