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

17 de junho de 2014 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

331

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha
        • 248.629.4902 Boehringer Ingelheim Investigational Site
      • Berlin (Hellersdorf), Alemanha
        • 248.629.4904 Boehringer Ingelheim Investigational Site
      • Berlin-Steglitz, Alemanha
        • 248.629.4903 Boehringer Ingelheim Investigational Site
      • Bochum, Alemanha
        • 248.629.4908 Boehringer Ingelheim Investigational Site
      • Ellwangen, Alemanha
        • 248.629.4901 Boehringer Ingelheim Investigational Site
      • Herborn, Alemanha
        • 248.629.4906 Boehringer Ingelheim Investigational Site
      • Leipzig, Alemanha
        • 248.629.4905 Boehringer Ingelheim Investigational Site
      • Schwerin, Alemanha
        • 248.629.4909 Boehringer Ingelheim Investigational Site
      • Würzburg, Alemanha
        • 248.629.4907 Boehringer Ingelheim Investigational Site
  • Bélgica
      • Edegem, Bélgica
        • 248.629.3201 Boehringer Ingelheim Investigational Site
  • Eslováquia
      • Bratislava, Eslováquia
        • 248.629.4204 Boehringer Ingelheim Investigational Site
      • Bratislava, Eslováquia
        • 248.629.4205 Boehringer Ingelheim Investigational Site
      • Brezno, Eslováquia
        • 248.629.4202 Boehringer Ingelheim Investigational Site
      • Kosice, Eslováquia
        • 248.629.4201 Boehringer Ingelheim Investigational Site
      • Martin, Eslováquia
        • 248.629.4203 Boehringer Ingelheim Investigational Site
  • Espanha
      • Barcelona, Espanha
        • 248.629.3402 Boehringer Ingelheim Investigational Site
      • Granada, Espanha
        • 248.629.3405 Boehringer Ingelheim Investigational Site
      • Madrid, Espanha
        • 248.629.3401 Boehringer Ingelheim Investigational Site
      • San Sebastián, Espanha
        • 248.629.3403 Boehringer Ingelheim Investigational Site
      • Valencia, Espanha
        • 248.629.3406 Hospital Arnau de Vilanova
  • Finlândia
      • Espoo, Finlândia
        • 248.629.35801 Boehringer Ingelheim Investigational Site
      • Helsinki, Finlândia
        • 248.629.35805 Boehringer Ingelheim Investigational Site
      • Joensuu, Finlândia
        • 248.629.35804 Boehringer Ingelheim Investigational Site
      • Oulu, Finlândia
        • 248.629.35802 Boehringer Ingelheim Investigational Site
      • Tampere, Finlândia
        • 248.629.35806 Boehringer Ingelheim Investigational Site
  • Holanda
      • Bennebroek, Holanda
        • 248.629.31001 Boehringer Ingelheim Investigational Site
      • Hoogwoud, Holanda
        • 248.629.31005 Boehringer Ingelheim Investigational Site
      • Musselkanaal, Holanda
        • 248.629.31006 Boehringer Ingelheim Investigational Site
      • Oude Pekela, Holanda
        • 248.629.31002 Boehringer Ingelheim Investigational Site
      • Oude Pekela, Holanda
        • 248.629.31003 Boehringer Ingelheim Investigational Site
      • Rijswijk, Holanda
        • 248.629.31004 Boehringer Ingelheim Investigational Site
  • Irlanda
      • Carrigtwohill, Irlanda
        • 248.629.35301 Boehringer Ingelheim Investigational Site
      • Co. Kildare, Irlanda
        • 248.629.35302 Boehringer Ingelheim Investigational Site
      • Co. Tipperary, Irlanda
        • 248.629.35303 Boehringer Ingelheim Investigational Site
  • Reino Unido
      • Chorley, Reino Unido
        • 248.629.44003 Boehringer Ingelheim Investigational Site
      • Edgbaston, Birmingham, Reino Unido
        • 248.629.44006 Boehringer Ingelheim Investigational Site
      • Glasgow, Reino Unido
        • 248.629.44004 Boehringer Ingelheim Investigational Site
      • Manchester, Reino Unido
        • 248.629.44001 Boehringer Ingelheim Investigational Site
      • Reading, Reino Unido
        • 248.629.44002 Boehringer Ingelheim Investigational Site
      • Waterloo, Liverpool, Reino Unido
        • 248.629.44005 Boehringer Ingelheim Investigational Site
  • Áustria
      • Innsbruck, Áustria
        • 248.629.4302 Boehringer Ingelheim Investigational Site
      • Linz, Áustria
        • 248.629.4304 Boehringer Ingelheim Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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);

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: Pramipexol
Comparador de Placebo: Placebo
4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.
Medicamento: Placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks
Prazo: Baseline and 26 weeks
IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)
Baseline and 26 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Standing Systolic Blood Pressure
Prazo: Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Supine Diastolic Blood Pressure
Prazo: Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Standing Diastolic Blood Pressure
Prazo: Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Supine Pulse Rate
Prazo: Baseline, Week 26
Baseline, Week 26
Baseline, Week 26 Mean Standing Pulse Rate
Prazo: Baseline, Week 26
Baseline, Week 26

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2007

Conclusão Primária (Real)

1 de julho de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

10 de maio de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de maio de 2007

Primeira postagem (Estimativa)

11 de maio de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

27 de junho de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2014

Última verificação

1 de maio de 2012

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 248.629
  • EUDRACT2006-006431-42

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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