Status:
COMPLETED
Drug and Non-Drug Treatment Of Severe Migraine
Lead Sponsor:
Ohio University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Merck Sharp & Dohme LLC
Conditions:
Migraine Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 t...
Detailed Description
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00910689
Start Date
July 1 2001
End Date
November 1 2005
Last Update
November 22 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio University
Athens, Ohio, United States, 45701
2
OrthoNeuro, Inc.
Westerville, Ohio, United States, 43081