Drug and Non-Drug Treatment Of Severe Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Propranolol or nadolol; Placebo control; Behavioral Migraine Management (BMM); Optimal Acute Therapy
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): 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.
Other intervention name(s): Inderal; Nadolol; Behavioral Treatment; BMM; Imitrex®; Maxalt®; Reglan®; Advil®; Motrin®; Nuprin®
Intervention MeSH terms: Propranolol; Nadolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine Headache; Preventive Therapy; Beta Blocker Medication; Behavior Therapy; Clinical Trial