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- Ensaio Clínico NCT01833130
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
18 de setembro de 2015 atualizado por: Allergan
This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
52
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
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California
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San Francisco, California, Estados Unidos
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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 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- History of chronic migraine for at least 6 months prior to the screening visit
- Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)
Exclusion Criteria:
- Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
- Use of headache prophylaxis medication within 4 weeks of the screening visit
- Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- Previous use of any botulinum toxin of any serotype for any reason
- Skin infections or acne that would interfere with the injection sites
- Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of 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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
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OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Outros nomes:
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Comparador de Placebo: Placebo (Normal saline)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
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Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
Prazo: Baseline, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
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Baseline, Week 24
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire
Prazo: Baseline, Week 24
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The ACM-S is 12 question migraine symptom scale over the past 24 hours.
The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.
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Baseline, Week 24
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Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire
Prazo: Baseline, Week 24
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The ACM-S is 12 question migraine symptom scale over the past 24 hours.
The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.
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Baseline, Week 24
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Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The ADL-I is a subdomain on the ACM-I.
The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The EMO-I is a subdomain on the ACM-I.
The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The WS-I is a subdomain on the ACM-I.
The WS-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The SOC-I is a subdomain on the ACM-I.
The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The LEA-I is a subdomain on the ACM-I.
The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The HOS-I is a subdomain on the ACM-I.
The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The ENE-I is a subdomain on the ACM-I.
The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The COG-I is a subdomain on the ACM-I.
The COG-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire
Prazo: Baseline, Week 12, Week 22, Week 24
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The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days.
The GEN-I is a subdomain on the ACM-I.
The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.
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Baseline, Week 12, Week 22, Week 24
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Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score
Prazo: Baseline, Week 24
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The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life.
The total score ranged from 36 (no impact) to 78 (worst impact).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
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Baseline, Week 24
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Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)
Prazo: Baseline, Week 24
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The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks.
The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.
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Baseline, Week 24
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Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ
Prazo: Baseline, Week 24
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The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks.
The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.
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Baseline, Week 24
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Change From Baseline in the Emotional Function (EF) Domain of the MSQ
Prazo: Baseline, Week 24
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The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks.
The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time).
A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.
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Baseline, Week 24
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 abril de 2013
Conclusão Primária (Real)
1 de setembro de 2014
Conclusão do estudo (Real)
1 de setembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
12 de abril de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de abril de 2013
Primeira postagem (Estimativa)
16 de abril de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de outubro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de setembro de 2015
Última verificação
1 de setembro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Cefaleias Primárias
- Distúrbios de dor de cabeça
- Transtornos de Enxaqueca
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Agentes colinérgicos
- Moduladores de transporte de membrana
- Inibidores da Liberação de Acetilcolina
- Agentes Neuromusculares
- Toxinas Botulínicas
- Toxinas Botulínicas, Tipo A
- toxina abobotulínica A
Outros números de identificação do estudo
- GMA-BTX-CM-12-545
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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