A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

Study Overview
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Brief Summary
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The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole. Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment, sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of symptom severity and improvement. Another secondary objective is safety and tolerability of treatment.

Official Title
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A Double-blind, Placebo-controlled, Randomised Withdrawal Study of 3 Month Duration in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Pramipexole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female out-patients aged 18-80 Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group RLSRS score > 15 RLS symptoms present at least 2 to 3 days per week within the last 3 months Written informed consent Exclusion Criteria: Women of childbearing potential without adequate contraception, or breastfeeding Concomitant or previous pharmacologically therapy of RLS Clinically significant renal disease, and/or hepatic disease Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease History or clinical signs of peripheral neuropathy (PNP), myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms, history of or clinical signs for any form of epilepsy or seizures Presence of any sleep disorder History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction History of or clinical signs of malign neoplasm Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated Allergic to pramipexole or its excipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pramipexole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set |  | from randomization up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to target event for per protocol set (period 2) |  | from randomization up to 3 months | 
| Number of target events (period 2) |  | from randomization up to 3 months | 
| Change from baseline (visit 10) in the total score of Restless Legs Syndrome Rating Scale for Severity (RLSRS) (period 2) |  | from randomization up to 3 months | 
| Clinical Global Impressions - Global Improvement (period 2) |  | from randomization up to 3 months | 
| Change from baseline (visit 10) in Clinical Global Impressions - Severity of illness score (CGI-S) by 2 or more categories (period 2) |  | from randomization up to 3 months | 
| Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2) |  | from randomization up to 3 months | 
| Clinical Global Impressions - Side Effects (CGI-SE) (period 2) |  | from randomization up to 3 months | 
| Change in Patient global impression (PGI) (period 2) |  | from randomization up to 3 months | 
| Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2) |  | from randomization up to 3 months | 
| Change from baseline (visit 10) in Visual analogue scales (RLS-VASs) for assessment of RLS symptoms (period 2) |  | from randomization up to 3 months | 
| Change from baseline (visit 10) in Epworth sleepiness scale (ESS) |  | from randomization up to 3 months | 
| Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2) |  | up to 9 months | 
| Change from baseline ASRS (period 1) |  | up to 6 months | 
| Change from baseline in the total score of RLSRS (period 1) |  | up to 6 months | 
| RLSRS responder status by visit (non-responder, partial responder, responder) (period 1) |  | after 6 months | 
| RLSRS responder status for patients who discontinued the study prematurely in period 1 by reason for discontinuation (period 1) |  | up to 6 months | 
| Clinical Global Impressions - Global Improvement (period 1) |  | 6 months | 
| Clinical Global Impressions - Severity of illness score (CGI-S) (period 1) |  | 6 months | 
| Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1) |  | 6 months | 
| Clinical Global Impressions - Side Effects (CGI-TE) (period 1) |  | 6 months | 
| Change in patient global impression from baseline (period 1) |  | 6 months | 
| Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1) |  | 6 months | 
| Change from baseline in RLS-VASs (period 1) |  | 6 months | 
| Change from baseline in ESS |  | 6 months |