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Completed

NCT Number: NCT00472199

Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

248.629.4302 Boehringer Ingelheim Investigational Site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (IRB/IEC) requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments
  • Male or female out-patients aged 18-85 years
  • Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG) [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS.
  • RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
  • IRLS total score >15 at baseline (Visit 2)

Exclusion criteria

  • Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization
  • Any woman of child-bearing potential not having a negative pregnancy test at screening
  • Breastfeeding women
  • Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
  • Diagnosis of augmentation under previous pharmacological RLS treatment
  • Concomitant or previous pharmacologic therapy as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2); Any intake of levodopa within 14 days prior to baseline (Visit 2); Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);

Treatment and study plan

Pramipexole

Drug

Placebo

Drug

Primary outcomes

  1. Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks

    Time frame: Baseline and 26 weeks

    IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)

Secondary outcomes

  1. Clinical Global Impression - Global Improvement (CGI-I) Responder Rate

    Time frame: after 26 weeks of treatment

    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)

  2. International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate

    Time frame: after 26 weeks of treatment

    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)

  3. Patient Global Impression (PGI) Responder Rate

    Time frame: after 26 weeks of treatment

    PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)

  4. Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks

    Time frame: baseline and 26 weeks of treatment

    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

  5. Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    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

  6. Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks

    Time frame: baseline and 26 weeks of treatment

    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

  7. Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    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

  8. Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    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

  9. Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    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

  10. Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)

  11. Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)

  12. Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks

    Time frame: Baseline and 26 weeks of treatment

    RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life

  13. Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating less bodily pain

  14. Change From Baseline in SF-36 Dimension General Health After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better health status

  15. Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better mental health

  16. Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better physical functioning

  17. Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems

  18. Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems

  19. Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better social functioning

  20. Change From Baseline in SF-36 Dimension Vitality After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better vitality

  21. Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better health

  22. Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks

    Time frame: Baseline and 26 weeks

    Score ranging from 0 to 100 with higher scores indicating better health

  23. Diagnosis of Classified Augmentation According to Independent Expert Panel

    Time frame: after at least 4 weeks of treatment

    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.

  24. Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation

    Time frame: after at least 1 week of 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.

  25. Baseline, Week 26 Mean Supine Systolic Blood Pressure

    Time frame: Baseline, Week 26

  26. Baseline, Week 26 Mean Standing Systolic Blood Pressure

    Time frame: Baseline, Week 26

  27. Baseline, Week 26 Mean Supine Diastolic Blood Pressure

    Time frame: Baseline, Week 26

  28. Baseline, Week 26 Mean Standing Diastolic Blood Pressure

    Time frame: Baseline, Week 26

  29. Baseline, Week 26 Mean Supine Pulse Rate

    Time frame: Baseline, Week 26

  30. Baseline, Week 26 Mean Standing Pulse Rate

    Time frame: Baseline, Week 26

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period

Important dates

Study start
2007
Primary completion
2008
First posted
May 11, 2007
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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