Trip-Tox, Effectiveness of Triptans Before and After Onabotulinumtoxin A Treatment in Chronic Migraine
Trip-tox Study. Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment
연구 개요
상세 설명
Hypothesis In patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxinA.
Objectives To analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxinA, at 4 months, after two sessions of Botox, and at 7 months of treatment, after three sessions of Botox.
Sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxinA is indicated. The indication for Botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue.
All patients signed the informed consent and the study was approved by the Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Robert Belvís, PhD
- 전화번호: +34 93 291 90 00
- 이메일: rbelvis@santpau.cat
연구 장소
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Barcelona, 스페인
- 모병
- Headache and Neuralgia Unit. Neurology Department. Hospital Santa Creu i Sant Pau
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연락하다:
- Robert Belvís, PhD
- 전화번호: +34 93 291 90 00
- 이메일: rbelvis@santpau.cat
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- ICHD-3 criteria for chronic migraine (code 1.3). See Table 3.
- Older than 18 years and younger than 65 years.
- Migraine started in their lifetime before the age of 50 years.
- Migraine of more than one year of evolution since diagnosis.
- Normal cranial CT/MRI study.
- Indication for treatment with Botox
- Taking triptans as a rescue treatment for migraine attacks
Exclusion Criteria:
- Pregnant women
- Migraine of less than one year of evolution since diagnosis.
- Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients with chronic migraine
In the same group of patients, the response to triptans will be analyzed at 3 different times with respect to the start of treatment with onabotulinumtoxinA: before treatment, after 4 months and after 7 months of treatment.
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To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change efficacy (Pain free at two hours )
기간: From baseline to 4 months
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Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.
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From baseline to 4 months
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Change efficacy (Pain free at two hours )
기간: From baseline to 7 months
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Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.
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From baseline to 7 months
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Satisfaction (Likert scale 1-5)
기간: From baseline to 4 months
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Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
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From baseline to 4 months
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Satisfaction (Likert scale 1-5)
기간: From baseline to 7 months
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Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
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From baseline to 7 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain free at one hour
기간: 4 and 7 months
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Percentage of patients who are completely free of pain after one hour of ingestion of their usual triptan.
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4 and 7 months
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Sustained pain-free
기간: 4 and 7 months
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Percentage of patients who achieve pain-free at two hours and do not require rescue medication within 24-48 hours.
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4 and 7 months
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Headache relapse
기간: 4 and 7 months
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Percentage of patients experiencing recurrence of pain within 48 h on triptans with long half-life or 24 h on triptans with short half-life.
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4 and 7 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Belvís, PhD, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IIBSP-TOX-2020-67
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