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Drug and Non-Drug Treatment Of Severe Migraine

Information source: Ohio University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Headache

Intervention: Propranolol or nadolol (Drug); Placebo control (Drug); Behavioral Migraine Management (BMM) (Behavioral); Optimal Acute Therapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ohio University

Official(s) and/or principal investigator(s):
Kenneth A Holroyd, Ph.D., Principal Investigator, Affiliation: Ohio University

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.

Clinical Details

Official title: Drug and Non-Drug Treatment of Severe Migraine

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Number of Migraine Episodes Per 30 Days at Month 10.

Secondary outcome:

Change in the Number of Migraine Days Per 30 Days at Month 10

Change in Quality of Life at Month 10

Change in Number of Migraine Episodes Per 30 Days at Month 16.

Change in the Number of Migraine Days Per 30 Days at Month 16

Change in Quality of Life at Month 16

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Ohio University, Athens, Ohio 45701, United States

OrthoNeuro, Inc., Westerville, Ohio 43081, United States

Additional Information

Related publications:

Martin BC, Pathak DS, Sharfman MI, Adelman JU, Taylor F, Kwong WJ, Jhingran P. Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1). Headache. 2000 Mar;40(3):204-15.

Starting date: July 2001
Last updated: June 4, 2009

Page last updated: August 23, 2015

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