The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome

Condition(s) targeted: Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)

Intervention: Ropinirole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline

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 important for decisions no therapy to know whether a drug could improve both depressive and RLS symptoms.

Official title: A Multicenter 3:1-Randomized Placebo-Controlled Double-Blind Phase IIIb Study on the Effects of Ropinirole on Mood/(Subclinical) Depression in the Therapy of Patients With Moderate to Severe Idiopathic RLS in Germany

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: to compare efficacy of ropinirole and placebo on improving mood in patients with moderate to severe idiopathic RLS and some depressive symptoms, change on a depression rating scale after 12 weeks treatment with ropinirole versus placebo is measured.

Secondary outcome:

The efficacy of ropinirole in improving mood in patient with different severities of depression will be measured. Also the efficacy of ropinirole in improving the symptoms of RLS and sleep will be assessed. Some endpoints will include safety measures.

·Change from baseline at week 12 in Sleep II Index, as measured by MOS sleep scale.

·Change from baseline at week 12 in sleep quantity, as measured by the MOS sleep scale.

·Change form baseline at week 12 in somnolence, as measured by the MOS sleep scale.

·Time to response on the Clinical Global Impression (Global Improvement) (CGI) scale.

·Proportion of patients with a score of much-improved (2) or very much-improved (1) on the CGI (Global Improvement) scale at day 8, weeks 4, 8 and 12 LOCF (last observation carried forward).

·Change from baseline at week 12 in the overall life impact score on the RLS QOL Questionnaire.

·Change from baseline at week 12 in all domains of the SF-36.

·CGI improvement and severity at day 8, weeks 4, 8 and 12.

·Changes from baseline at week 12 in number of days with RLS symptoms.

·Changes from baseline at week 12 in number of awakenings per night due to RLS symptoms.

Changes from baseline in visual analogue scale score (patients own assessment of their overall health) to day 8, weeks 4, 8 and 12

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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).

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Starting date: June 2006
Ending date: December 2007
Last updated: February 28, 2008