Drug and Non-Drug Treatment Of Severe Migraine

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio University
• Collaborators: GlaxoSmithKline; Merck Sharp & Dohme Corp.; National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Adrenergic beta-Antagonists; Nadolol; Propranolol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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