Drug and Non-Drug Treatment Of Severe Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Propranolol or nadolol; Placebo control; Behavioral Migraine Management (BMM); Optimal Acute Therapy
Intervention description: Treatment initiated with 1 capsule (60 mg long acting propranolol hydrochloride) and increased to 3 capsules (180 mg) at week 12 as tolerated. If subject does not tolerate at least 2 capsules (120 mg) of propranolol hydrochloride-LA, and in treating neurologist's judgment are unimproved, subject switched to second medication (nadolol). Participants initially receive a single 40 mg capsule of nadolol and increased to 2 capsules (80 mg) as tolerated. At week 12 dose stabilized at highest tolerated level. In evaluation phase, an increase to 4 capsules of long acting propranolol hydrochloride (240 mg) or 3 capsules of nadolol (120 mg) permitted.; Placebo; Session 1: Overview of the pathophysiology of migraine; introduce muscle stretching, deep breathing, PMR, imagery; Session 2: Development trigger management strategy; Use early warning signs as a cue to use behavioral migraine management and acute medication; Session 3:(a) continue with "basic" migraine management skills if these skills have not been mastered;(b) introduce cognitive-behavioral stress-management, if stress is a salient migraine trigger;(c) introduce thermal biofeedback ("hand warming") training with a portable home thermal biofeedback device, if stress is not a notable migraine trigger. Session 4: Review problems using various behavioral migraine management skills; Prepare written migraine management plan; Relapse prevention addressed; This acute therapy protocol emphasized treatment with a 5-HT1B/D-agonist or triptan. Nonsteroidal anti-inflammatory (NSAID; ibuprofen) and anti-emetic (metoclopramide) medication could be added as needed. The choice of triptans (rizatriptan®, sumatriptan®), the route(s) of triptan administration (oral, nasal spray, subcutaneous injection), and the addition of a NSAID, or anti-emetic were tailored to participant preference, treatment history and acute therapy response. Individualized handouts and a phone call (week 3) of the OAT Run-in were used to help participants evaluate and optimize their acute therapy.
Intervention MeSH terms: Propranolol; Nadolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine Headache; Preventive Therapy; Beta Blocker Medication; Behavior Therapy; Clinical Trial

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.
    

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