Drug and Non-Drug Treatment Of Severe Migraine
Completed · Phase 4 · Has a placebo group
Conditions studied: Migraine Headache
In brief
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.
Key facts
- Study ID
- NCT00910689
- Run by
- Ohio University
- People needed
- 232
- Starts
- 2001-07-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2016-11-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ohio University — Athens, Ohio, United States
- OrthoNeuro, Inc. — Westerville, Ohio, United States
Full record on ClinicalTrials.gov
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