Restless Legs Syndrome
Conditions
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.
Interventions
DRUGPramipexole
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to target event for per protocol set (period 2) | from randomization up to 3 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 |
| Change from baseline ASRS (period 1) | up to 6 months |
Countries
Germany
Outcome results
None listed