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Drug and Non-Drug Treatment Of Severe Migraine (TSM)

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ClinicalTrials.gov Identifier: NCT00910689
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : June 1, 2009
Last Update Posted : November 22, 2016
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Merck Sharp & Dohme Corp.
GlaxoSmithKline
Information provided by:
Ohio University

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE June 1, 2009
Results First Submitted Date  ICMJE November 24, 2008
Results First Posted Date  ICMJE June 1, 2009
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE July 2001
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
Change in Number of Migraine Episodes Per 30 Days at Month 10. [ Time Frame: Change from Month 1 to Month 10 ]
Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2009)
Change in Number of Migraine Episodes Per 30 Days at Month 10. [ Time Frame: Change from Month 1 to Month 10 ]
Change History Complete list of historical versions of study NCT00910689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • Change in the Number of Migraine Days Per 30 Days at Month 10 [ Time Frame: Change from Month 1 to Month 10 ]
    Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary.
  • Change in Quality of Life at Month 10 [ Time Frame: Change from Month 1 to Month 10 ]
    Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.
  • Change in Number of Migraine Episodes Per 30 Days at Month 16. [ Time Frame: Change from Month 1 to Month 16 ]
    Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary.
  • Change in the Number of Migraine Days Per 30 Days at Month 16 [ Time Frame: Change form Month 1 to Month 16 ]
    Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary.
  • Change in Quality of Life at Month 16 [ Time Frame: Change from Month 1 to Month 16 ]
    Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2009)
  • Change in the Number of Migraine Days Per 30 Days at Month 10 [ Time Frame: Change from Month 1 to Month 10 ]
  • Change in Quality of Life at Month 10 [ Time Frame: Change from Month 1 to Month 10 ]
  • Change in Number of Migraine Episodes Per 30 Days at Month 16. [ Time Frame: Change from Month 1 to Month 16 ]
  • Change in the Number of Migraine Days Per 30 Days at Month 16 [ Time Frame: Change form Month 1 to Month 16 ]
  • Change in Quality of Life at Month 16 [ Time Frame: Change from Month 1 to Month 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug and Non-Drug Treatment Of Severe Migraine
Official Title  ICMJE Drug and Non-Drug Treatment of Severe Migraine
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: Propranolol or nadolol
    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.
    Other Names:
    • Inderal
    • Nadolol
  • Drug: Placebo control
    Placebo
  • Behavioral: Behavioral Migraine Management (BMM)
    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
    Other Names:
    • Behavioral Treatment
    • BMM
  • Drug: Optimal Acute Therapy
    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 Names:
    • Imitrex®
    • Maxalt®
    • Reglan®
    • Advil®
    • Motrin®
    • Nuprin®
Study Arms  ICMJE
  • Placebo Comparator: 1
    Optimal Acute Therapy plus Beta Blocker Placebo
    Interventions:
    • Drug: Placebo control
    • Drug: Optimal Acute Therapy
  • Active Comparator: 2
    Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
    Interventions:
    • Drug: Propranolol or nadolol
    • Drug: Optimal Acute Therapy
  • Active Comparator: 3
    Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker placebo
    Interventions:
    • Drug: Placebo control
    • Behavioral: Behavioral Migraine Management (BMM)
    • Drug: Optimal Acute Therapy
  • Active Comparator: 4
    Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
    Interventions:
    • Drug: Propranolol or nadolol
    • Behavioral: Behavioral Migraine Management (BMM)
    • Drug: Optimal Acute Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2009)
232
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00910689
Other Study ID Numbers  ICMJE 2R01NS032374( U.S. NIH Grant/Contract )
NS32374
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Holroyd, Distinguished Professor. Department of Psychology, Ohio University
Study Sponsor  ICMJE Ohio University
Collaborators  ICMJE
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Merck Sharp & Dohme Corp.
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Kenneth A Holroyd, Ph.D. Ohio University
PRS Account Ohio University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP