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.)
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.)
1 other identifier
interventional
224
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedNovember 19, 2013
November 1, 2013
1.1 years
September 8, 2005
November 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (24)
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
- +19 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Boehringer Ingelheim Investigational Site
Berlin, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
emovis GmbH
Berlin, Germany
Boehringer Ingelheim Investigational Site
Chemnitz, Germany
ClinPharm Internat. GmbH & Co. KG
Görlitz, Germany
Clinpharm International GmbH & Co. KG
Hellersdorf, Germany
Paracelsus-Elena-Klinik
Kassel, Germany
ClinPharm International GmbH & Co. KG
Leipzig, Germany
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg, Germany
Universitätsklinikum Giessen und Marburg
Marburg, Germany
Boehringer Ingelheim Investigational Site
München, Germany
Boehringer Ingelheim Investigational Site
Würzburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2004
Primary Completion
February 1, 2005
Last Updated
November 19, 2013
Record last verified: 2013-11