Clinical trial NCT00910689: Drug and Non-Drug Treatment Of Severe Migraine
Official title: Drug and Non-Drug Treatment of Severe Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Headache
Keywords: Migraine Headache
Preventive Therapy
Beta Blocker Medication
Behavior Therapy
Clinical Trial
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Merck Sharp & Dohme LLC
name: GlaxoSmithKline
First posted: 2009-06-01
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the outcome of optimal acute therapy for frequent migraines.

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 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

Primary outcomes:
measure: Change in Number of Migraine Episodes Per 30 Days at Month 10.
timeFrame: Change from Month 1 to Month 10
Secondary outcomes:
measure: Change in the Number of Migraine Days Per 30 Days at Month 10
timeFrame: Change from Month 1 to Month 10
measure: Change in Quality of Life at Month 10
timeFrame: Change from Month 1 to Month 10
measure: Change in Number of Migraine Episodes Per 30 Days at Month 16.
timeFrame: Change from Month 1 to Month 16
measure: Change in the Number of Migraine Days Per 30 Days at Month 16
timeFrame: Change form Month 1 to Month 16
measure: Change in Quality of Life at Month 16
timeFrame: Change from Month 1 to Month 16
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
city: Westerville
country: United States
facility: OrthoNeuro, Inc.
state: Ohio
Study officials:
affiliation: Ohio University
name: Kenneth A Holroyd, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1046/j.1526-4610.2000.00030.x.
citation: Holroyd KA, Cottrell CK, O'Donnell FJ, Cordingley GE, Drew JB, Carlson BW, Himawan L. Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ. 2010 Sep 29;341:c4871. doi: 10.1136/bmj.c4871.