Clinical trial NCT00152958: 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.)
Official title: 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.)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set
timeFrame: from randomization up to 3 months
Secondary outcomes:
measure: Time to target event for per protocol set (period 2)
timeFrame: from randomization up to 3 months
measure: Number of target events (period 2)
timeFrame: from randomization up to 3 months
measure: Change from baseline (visit 10) in the total score of Restless Legs Syndrome Rating Scale for Severity (RLSRS) (period 2)
timeFrame: from randomization up to 3 months
measure: Clinical Global Impressions - Global Improvement (period 2)
timeFrame: from randomization up to 3 months
measure: Change from baseline (visit 10) in Clinical Global Impressions - Severity of illness score (CGI-S) by 2 or more categories (period 2)
timeFrame: from randomization up to 3 months
measure: Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2)
timeFrame: from randomization up to 3 months
measure: Clinical Global Impressions - Side Effects (CGI-SE) (period 2)
timeFrame: from randomization up to 3 months
measure: Change in Patient global impression (PGI) (period 2)
timeFrame: from randomization up to 3 months
measure: Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2)
timeFrame: from randomization up to 3 months
measure: Change from baseline (visit 10) in Visual analogue scales (RLS-VASs) for assessment of RLS symptoms (period 2)
timeFrame: from randomization up to 3 months
measure: Change from baseline (visit 10) in Epworth sleepiness scale (ESS)
timeFrame: from randomization up to 3 months
measure: Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2)
timeFrame: up to 9 months
measure: Change from baseline ASRS (period 1)
timeFrame: up to 6 months
measure: Change from baseline in the total score of RLSRS (period 1)
timeFrame: up to 6 months
measure: RLSRS responder status by visit (non-responder, partial responder, responder) (period 1)
timeFrame: after 6 months
measure: RLSRS responder status for patients who discontinued the study prematurely in period 1 by reason for discontinuation (period 1)
timeFrame: up to 6 months
measure: Clinical Global Impressions - Global Improvement (period 1)
timeFrame: 6 months
measure: Clinical Global Impressions - Severity of illness score (CGI-S) (period 1)
timeFrame: 6 months
measure: Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1)
timeFrame: 6 months
measure: Clinical Global Impressions - Side Effects (CGI-TE) (period 1)
timeFrame: 6 months
measure: Change in patient global impression from baseline (period 1)
timeFrame: 6 months
measure: Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1)
timeFrame: 6 months
measure: Change from baseline in RLS-VASs (period 1)
timeFrame: 6 months
measure: Change from baseline in ESS
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin (Hellersdorf)
country: Germany
facility: Clinpharm International GmbH & Co. KG
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: emovis GmbH
city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Görlitz
country: Germany
facility: ClinPharm Internat. GmbH & Co. KG
city: Kassel
country: Germany
facility: Paracelsus-Elena-Klinik
city: Leipzig
country: Germany
facility: ClinPharm International GmbH & Co. KG
city: Magdeburg
country: Germany
facility: Neurologische Klinik der Otto-von-Guericke-Universität
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: