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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
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Concomitant or previous pharmacologically therapy of RLS
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Clinically significant renal disease, and/or hepatic disease
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Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen
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Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease
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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
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Presence of any sleep disorder
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History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction
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History of or clinical signs of malign neoplasm
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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
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Allergic to pramipexole or its excipients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinpharm International GmbH & Co. KG | Berlin (Hellersdorf) | Germany | ||
| 2 | Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 3 | Charité Campus Virchow-Klinikum | Berlin | Germany | ||
| 4 | emovis GmbH | Berlin | Germany | ||
| 5 | Boehringer Ingelheim Investigational Site | Chemnitz | Germany | ||
| 6 | ClinPharm Internat. GmbH & Co. KG | Görlitz | Germany | ||
| 7 | Paracelsus-Elena-Klinik | Kassel | Germany | ||
| 8 | ClinPharm International GmbH & Co. KG | Leipzig | Germany | ||
| 9 | Neurologische Klinik der Otto-von-Guericke-Universität | Magdeburg | Germany | ||
| 10 | Universitätsklinikum Giessen und Marburg | Marburg | Germany | ||
| 11 | Boehringer Ingelheim Investigational Site | München | Germany | ||
| 12 | Boehringer Ingelheim Investigational Site | Würzburg | Germany |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 248.546