이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

2015년 9월 18일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

52

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • San Francisco, California, 미국

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: OnabotulinumtoxinA
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.
다른 이름들:
  • 보톡스®
  • 보툴리눔 독소 A형
위약 비교기: Placebo (Normal saline)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
의약품: Normal saline (placebo)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
기간: Baseline, Week 24
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.
Baseline, Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire
기간: Baseline, Week 24
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.
Baseline, Week 24
Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire
기간: Baseline, Week 24
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.
Baseline, Week 24
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire
기간: Baseline, Week 12, Week 22, Week 24
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.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score
기간: Baseline, Week 24
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.
Baseline, Week 24
Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)
기간: Baseline, Week 24
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.
Baseline, Week 24
Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ
기간: Baseline, Week 24
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.
Baseline, Week 24
Change From Baseline in the Emotional Function (EF) Domain of the MSQ
기간: Baseline, Week 24
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.
Baseline, Week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Allergan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 4월 1일

기본 완료 (실제)

2014년 9월 1일

연구 완료 (실제)

2014년 9월 1일

연구 등록 날짜

최초 제출

2013년 4월 12일

QC 기준을 충족하는 최초 제출

2013년 4월 12일

처음 게시됨 (추정)

2013년 4월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 10월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 9월 18일

마지막으로 확인됨

2015년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GMA-BTX-CM-12-545

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다