The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
331
248.629.4302 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
248.629.4304 Boehringer Ingelheim Investigational Site
Linz, Austria
248.629.3201 Boehringer Ingelheim Investigational Site
Edegem, Belgium
248.629.35801 Boehringer Ingelheim Investigational Site
Espoo, Finland
248.629.35805 Boehringer Ingelheim Investigational Site
Helsinki, Finland
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks
IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)
Time frame: Baseline and 26 weeks
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate
CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)
Time frame: after 26 weeks of treatment
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate
IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)
Time frame: after 26 weeks of treatment
Patient Global Impression (PGI) Responder Rate
PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)
Time frame: after 26 weeks of treatment
Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Time frame: baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks
The question was rated on an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Time frame: baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Time frame: Baseline and 26 weeks of treatment
Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks
Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks
The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks
RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating less bodily pain
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension General Health After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better health status
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better mental health
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better physical functioning
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better social functioning
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Vitality After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better vitality
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better health
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better health
Time frame: Baseline and 26 weeks
Diagnosis of Classified Augmentation According to Independent Expert Panel
Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.
Time frame: after at least 4 weeks of treatment
Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation
Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation). Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline.
Time frame: after at least 1 week of treatment discontinuation
Baseline, Week 26 Mean Supine Systolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Standing Systolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Supine Diastolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Standing Diastolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Supine Pulse Rate
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Standing Pulse Rate
Time frame: Baseline, Week 26
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248.629.35804 Boehringer Ingelheim Investigational Site
Joensuu, Finland
248.629.35802 Boehringer Ingelheim Investigational Site
Oulu, Finland
248.629.35806 Boehringer Ingelheim Investigational Site
Tampere, Finland
248.629.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.629.4908 Boehringer Ingelheim Investigational Site
Bochum, Germany
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