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Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

27 de julho de 2017 atualizado por: Acorda Therapeutics

Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

204

Estágio

  • Fase 3

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

  • Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3A 1M4
        • Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 3Z5
        • Chedoke-McMaster Hospital
      • Kingston, Ontario, Canadá, K7L 5A2
        • St. Mary's of the Lake Hospital
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • UAB School of Medicine, 190 Spain Rehab Center
    • California
      • Long Beach, California, Estados Unidos, 90822
        • Long Beach VA Medical Center
      • Sacramento, California, Estados Unidos, 95817
        • University of California, Davis
      • San Jose, California, Estados Unidos, 95128
        • Santa Clara Valley Medical Center
    • Colorado
      • Englewood, Colorado, Estados Unidos, 80110
        • Craig Hospital
    • Connecticut
      • New Britain, Connecticut, Estados Unidos, 06503
        • Hospital For Special Care
    • Illinois
      • Hines, Illinois, Estados Unidos, 60141
        • Hines VA Hospital
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02118
        • Boston University Medical Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Rehabilitation Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55417
        • Minneapolis VA Hospital
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65212
        • University of Missouri
      • Saint Louis, Missouri, Estados Unidos, 63104
        • St. Louis University
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester/Strong Memorial Hospital
      • Syracuse, New York, Estados Unidos, 13045
        • SUNY Upstate Clinical Trials Office
      • West Haverstraw, New York, Estados Unidos, 13045
        • Helen Hayes Hospital
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Charlotte Institute of Rehabilitation
      • Wilmington, North Carolina, Estados Unidos, 28402
        • Coastal AHEC
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Ohio State University
      • Dayton, Ohio, Estados Unidos, 45409
        • Miami Valley Hospital- Rehabilitation Institute of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University Hospital
    • Texas
      • Dallas, Texas, Estados Unidos, 75216
        • VA North Texas Health Care System
      • Dallas, Texas, Estados Unidos, 75390
        • Southwestern Medical Center at Dallas
    • Virginia
      • Falls Church, Virginia, Estados Unidos, 22042
        • INOVA Institute of Research and Education
      • Richmond, Virginia, Estados Unidos, 23298
        • Medical College of Virginia/VCU
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • University of Washington Medical Center, Dept. of Rehabilitation
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53295
        • Wood VA Medical Center

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 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
  • Moderate to severe lower-limb spasticity
  • Able to give informed consent and willing to comply with protocol

Exclusion Criteria:

  • Pregnancy
  • History of seizures
  • Existing or history of frequent Urinary Tract Infections
  • History of drug or alcohol abuse
  • Allergy to pyridine-containing substances
  • Received a botox injection 4 months prior to study
  • Received an investigational drug within 30 days
  • Previously treated with 4-aminopyridine (4-AP)
  • Not on stable medication dosing in 3 weeks prior to study
  • Abnormal ECG or laboratory value at screening

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Medicamento: Placebo
Placebo
Comparador Ativo: fampridina-SR 50mg/dia
Medicamento: Fampridina-SR
25mg bid (duas vezes ao dia)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Prazo: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98

The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:

1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.

The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores
Prazo: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98

The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.

The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
Prazo: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98

The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.

The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.

On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores
Prazo: Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.
Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score
Prazo: Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.
Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
Prazo: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98

Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.

Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.
Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
Prazo: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98

The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).

A positive change signifies improvement.
Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores
Prazo: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98

Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.

A negative change in patient bladder/bowel function diary score signifies improvement.
Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
Adjusted Mean Change in Subject Bowel Function Diary Scores
Prazo: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98

Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.

A negative change in patient bowel function diary score signifies improvement.
Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98

Colaboradores e Investigadores

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

Patrocinador

Acorda Therapeutics

Investigadores

  • Diretor de estudo: Andrew Blight, MD, Acorda Therapeutics

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

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 junho de 2002

Conclusão Primária (Real)

1 de novembro de 2003

Conclusão do estudo (Real)

1 de fevereiro de 2004

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de setembro de 2012

Primeira postagem (Estimativa)

12 de setembro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de agosto de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2017

Última verificação

1 de janeiro de 2014

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SCI-F302

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