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

2014年6月17日 更新者：Boehringer Ingelheim

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

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

331

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アイルランド
      • Carrigtwohill、アイルランド
        • 248.629.35301 Boehringer Ingelheim Investigational Site
      • Co. Kildare、アイルランド
        • 248.629.35302 Boehringer Ingelheim Investigational Site
      • Co. Tipperary、アイルランド
        • 248.629.35303 Boehringer Ingelheim Investigational Site
  • イギリス
      • Chorley、イギリス
        • 248.629.44003 Boehringer Ingelheim Investigational Site
      • Edgbaston, Birmingham、イギリス
        • 248.629.44006 Boehringer Ingelheim Investigational Site
      • Glasgow、イギリス
        • 248.629.44004 Boehringer Ingelheim Investigational Site
      • Manchester、イギリス
        • 248.629.44001 Boehringer Ingelheim Investigational Site
      • Reading、イギリス
        • 248.629.44002 Boehringer Ingelheim Investigational Site
      • Waterloo, Liverpool、イギリス
        • 248.629.44005 Boehringer Ingelheim Investigational Site
  • オランダ
      • Bennebroek、オランダ
        • 248.629.31001 Boehringer Ingelheim Investigational Site
      • Hoogwoud、オランダ
        • 248.629.31005 Boehringer Ingelheim Investigational Site
      • Musselkanaal、オランダ
        • 248.629.31006 Boehringer Ingelheim Investigational Site
      • Oude Pekela、オランダ
        • 248.629.31002 Boehringer Ingelheim Investigational Site
      • Oude Pekela、オランダ
        • 248.629.31003 Boehringer Ingelheim Investigational Site
      • Rijswijk、オランダ
        • 248.629.31004 Boehringer Ingelheim Investigational Site
  • オーストリア
      • Innsbruck、オーストリア
        • 248.629.4302 Boehringer Ingelheim Investigational Site
      • Linz、オーストリア
        • 248.629.4304 Boehringer Ingelheim Investigational Site
  • スペイン
      • Barcelona、スペイン
        • 248.629.3402 Boehringer Ingelheim Investigational Site
      • Granada、スペイン
        • 248.629.3405 Boehringer Ingelheim Investigational Site
      • Madrid、スペイン
        • 248.629.3401 Boehringer Ingelheim Investigational Site
      • San Sebastián、スペイン
        • 248.629.3403 Boehringer Ingelheim Investigational Site
      • Valencia、スペイン
        • 248.629.3406 Hospital Arnau de Vilanova
  • スロバキア
      • Bratislava、スロバキア
        • 248.629.4204 Boehringer Ingelheim Investigational Site
      • Bratislava、スロバキア
        • 248.629.4205 Boehringer Ingelheim Investigational Site
      • Brezno、スロバキア
        • 248.629.4202 Boehringer Ingelheim Investigational Site
      • Kosice、スロバキア
        • 248.629.4201 Boehringer Ingelheim Investigational Site
      • Martin、スロバキア
        • 248.629.4203 Boehringer Ingelheim Investigational Site
  • ドイツ
      • Berlin、ドイツ
        • 248.629.4902 Boehringer Ingelheim Investigational Site
      • Berlin (Hellersdorf)、ドイツ
        • 248.629.4904 Boehringer Ingelheim Investigational Site
      • Berlin-Steglitz、ドイツ
        • 248.629.4903 Boehringer Ingelheim Investigational Site
      • Bochum、ドイツ
        • 248.629.4908 Boehringer Ingelheim Investigational Site
      • Ellwangen、ドイツ
        • 248.629.4901 Boehringer Ingelheim Investigational Site
      • Herborn、ドイツ
        • 248.629.4906 Boehringer Ingelheim Investigational Site
      • Leipzig、ドイツ
        • 248.629.4905 Boehringer Ingelheim Investigational Site
      • Schwerin、ドイツ
        • 248.629.4909 Boehringer Ingelheim Investigational Site
      • Würzburg、ドイツ
        • 248.629.4907 Boehringer Ingelheim Investigational Site
  • フィンランド
      • Espoo、フィンランド
        • 248.629.35801 Boehringer Ingelheim Investigational Site
      • Helsinki、フィンランド
        • 248.629.35805 Boehringer Ingelheim Investigational Site
      • Joensuu、フィンランド
        • 248.629.35804 Boehringer Ingelheim Investigational Site
      • Oulu、フィンランド
        • 248.629.35802 Boehringer Ingelheim Investigational Site
      • Tampere、フィンランド
        • 248.629.35806 Boehringer Ingelheim Investigational Site
  • ベルギー
      • Edegem、ベルギー
        • 248.629.3201 Boehringer Ingelheim Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. 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
  2. Male or female out-patients aged 18-85 years
  3. 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.
  4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
  5. IRLS total score >15 at baseline (Visit 2)

Exclusion Criteria:

  1. 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
  2. Any woman of child-bearing potential not having a negative pregnancy test at screening
  3. Breastfeeding women
  4. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
  5. Diagnosis of augmentation under previous pharmacological RLS treatment
  6. 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);

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Pramipexole
4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks.
薬：プラミペキソール
プラセボコンパレーター：Placebo
4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.
薬：プラセボ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks
時間枠：Baseline and 26 weeks
IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)
Baseline and 26 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate
時間枠：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)
after 26 weeks of treatment
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate
時間枠：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)
after 26 weeks of treatment
Patient Global Impression (PGI) Responder Rate
時間枠：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)
after 26 weeks of treatment
Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks
時間枠：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
baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks
時間枠：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
Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks
時間枠：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
baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks
時間枠：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
Baseline and 26 weeks of treatment
Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks
時間枠：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
Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks
時間枠：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
Baseline and 26 weeks of treatment
Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks
時間枠：Baseline and 26 weeks of treatment
Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)
Baseline and 26 weeks of treatment
Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks
時間枠：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)
Baseline and 26 weeks of treatment
Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks
時間枠：Baseline and 26 weeks of treatment
RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life
Baseline and 26 weeks of treatment
Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating less bodily pain
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension General Health After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better health status
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better mental health
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better physical functioning
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better social functioning
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Vitality After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better vitality
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better health
Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks
時間枠：Baseline and 26 weeks
Score ranging from 0 to 100 with higher scores indicating better health
Baseline and 26 weeks
Diagnosis of Classified Augmentation According to Independent Expert Panel
時間枠：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.
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
時間枠：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.
after at least 1 week of treatment discontinuation
Baseline, Week 26 Mean Supine Systolic Blood Pressure
時間枠：Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Standing Systolic Blood Pressure
時間枠：Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Supine Diastolic Blood Pressure
時間枠：Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Standing Diastolic Blood Pressure
時間枠：Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Supine Pulse Rate
時間枠：Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Standing Pulse Rate
時間枠：Baseline, Week 26
Baseline, Week 26

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年5月1日

一次修了 (実際)

2008年7月1日

試験登録日

最初に提出

2007年5月10日

QC基準を満たした最初の提出物

2007年5月10日

最初の投稿 (見積もり)

2007年5月11日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年6月27日

QC基準を満たした最後の更新が送信されました

2014年6月17日

最終確認日

2012年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 248.629
  • EUDRACT2006-006431-42

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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