Drug and Non-Drug Treatment of Severe Migraine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Change in Number of Migraine Episodes Per 30 Days at Month 10.
研究概览
简要总结
The purpose of this study is to determine if the addition of preventive medication, behavior migraine management or the combination of preventive medication and behavior migraine management improves the outcome of optimal acute therapy for frequent migraines.
详细描述
During the 5 week Optimal Acute Therapy (OAT) Run in (Month 1) all participants who met initial inclusion criteria received "optimal" acute therapy (OAT). At the end of the OAT Run-in, participants who continued to meet the migraine severity criteria were stratified by sex and randomized via a computerized randomization procedure to the four added treatments: Beta Blocker Placebo (PL), Beta Blocker (Propranolol LA or Nadolol), Behavioral Migraine Management (BMM) + PL, or BMM + Beta Blocker. Each of the 4 treatment protocols required 4 monthly clinic visits and 3 telephone contacts during the 3 month Treatment/Dose Adjustment Phase (Month 2 to Month 4) where Beta Blocker or PL dose was adjusted and BMM was administered. During the 12 month (Month 5 to Month 16) Evaluation Phase clinic visits were scheduled at Month 5, Month 7, Month 10 (the Primary End Point), Month 13 and Month 16. Treatment conditions were blinded only for the preventive medication (Beta Blocker, Placebo) component, and not for the administration of BMM. Electronic headache diary recordings are obtained for the full 16 months of the trial, including the 12 month evaluation phase, and migraine-related impairments in quality of life are assessed at multiple points over the 16 months of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years
- •Diagnosis of migraine with or without aura (International Classification of Headache Disorders)
- •3 or more migraine episodes/month with disability for the past 6 months
- •Less than 20 total headache days/month for the past 6 months
排除标准
- •Medication overuse headaches
- •Currently taking medications contraindicated by study protocol and unable or unwilling to withdraw
- •Concurrently undergoing counseling/psychotherapy treatment
- •Unable to read, understand or record information in study diaries, questionnaires, and migraine management manual.
- •Unable/unwilling to give written informed consent
- •History of exclusionary medical condition such as, but not limited to, epilepsy, heart disease, kidney disease, liver disease, hepatic or renal impairment, stroke, ischemic abdominal syndromes, peripheral vascular disease.
- •Uncontrolled hypertension at screening (sitting systolic pressure > 160 mmHg, diastolic pressure > 95 mmHg)
- •Fertile female who is breastfeeding, pregnant planning a pregnancy within the next year or is unwilling to use adequate contraception.
- •Has exclusionary medical condition such as but not limited to diabetes (insulin dependent), tuberculosis, bronchospastic disease (asthma), heart disease (or multiple risk factors for heart disease), angina pectoris, documented silent ischemia, or cardiac arrythmias requiring medication, or a clinically significant EKG abnormality.
- •Other pain diagnosis is primary presenting problem (e.g., fibromyalgia)
- •Has a substance abuse problem or a psychological disorder that prevents participation in study (e.g., unmanaged severe depression that requires immediate treatment or limits participation in home-based treatment)
- •Hypersensitivity, intolerance or contraindication to use of Propranolol, Nadolol, Sumatriptan, or Rizatriptan
研究组 & 干预措施
1
Optimal Acute Therapy plus Beta Blocker Placebo
干预措施: Placebo control (Drug)
1
Optimal Acute Therapy plus Beta Blocker Placebo
干预措施: Optimal Acute Therapy (Drug)
2
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
干预措施: Propranolol or nadolol (Drug)
2
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
干预措施: Optimal Acute Therapy (Drug)
3
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker placebo
干预措施: Placebo control (Drug)
3
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker placebo
干预措施: Behavioral Migraine Management (BMM) (Behavioral)
3
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker placebo
干预措施: Optimal Acute Therapy (Drug)
4
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
干预措施: Propranolol or nadolol (Drug)
4
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
干预措施: Behavioral Migraine Management (BMM) (Behavioral)
4
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
干预措施: Optimal Acute Therapy (Drug)
结局指标
主要结局
Change in Number of Migraine Episodes Per 30 Days at Month 10.
时间窗: Change from Month 1 to Month 10
Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.
次要结局
- Change in the Number of Migraine Days Per 30 Days at Month 10(Change from Month 1 to Month 10)
- Change in Quality of Life at Month 10(Change from Month 1 to Month 10)
- Change in Number of Migraine Episodes Per 30 Days at Month 16.(Change from Month 1 to Month 16)
- Change in the Number of Migraine Days Per 30 Days at Month 16(Change form Month 1 to Month 16)
- Change in Quality of Life at Month 16(Change from Month 1 to Month 16)