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Trial record 4 of 507 for:    Migraine
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Drug and Non-Drug Treatment Of Severe Migraine (TSM)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Merck
GlaxoSmithKline
Information provided by:
Ohio University
ClinicalTrials.gov Identifier:
NCT00910689
First received: November 24, 2008
Last updated: June 4, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Migraine Headache
 Drug: Propranolol or nadolol
Drug: Placebo control
Behavioral: Behavioral Migraine Management (BMM)
Drug: Optimal Acute Therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug and Non-Drug Treatment of Severe Migraine

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Ohio University:

Primary Outcome Measures:
  • Change in Number of Migraine Episodes Per 30 Days at Month 10. [ Time Frame: Change from Month 1 to Month 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the Number of Migraine Days Per 30 Days at Month 10 [ Time Frame: Change from Month 1 to Month 10 ] [ Designated as safety issue: No ]
  • Change in Quality of Life at Month 10 [ Time Frame: Change from Month 1 to Month 10 ] [ Designated as safety issue: No ]
  • Change in Number of Migraine Episodes Per 30 Days at Month 16. [ Time Frame: Change from Month 1 to Month 16 ] [ Designated as safety issue: No ]
  • Change in the Number of Migraine Days Per 30 Days at Month 16 [ Time Frame: Change form Month 1 to Month 16 ] [ Designated as safety issue: No ]
  • Change in Quality of Life at Month 16 [ Time Frame: Change from Month 1 to Month 16 ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: July 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Optimal Acute Therapy plus Beta Blocker Placebo
 Drug: Placebo control
Placebo
Other Name: Placebo control
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®
Active Comparator: 2
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
 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: 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®
Active Comparator: 3
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker placebo
 Drug: Placebo control
Placebo
Other Name: Placebo control
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®
Active Comparator: 4
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
 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
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®

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910689

Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
OrthoNeuro, Inc.
Westerville, Ohio, United States, 43081
Sponsors and Collaborators
Ohio University
National Institute of Neurological Disorders and Stroke (NINDS)
Merck
GlaxoSmithKline
Investigators
Principal Investigator: Kenneth A Holroyd, Ph.D. Ohio University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kenneth Holroyd, Distinguished Professor. Department of Psychology, Ohio University
ClinicalTrials.gov Identifier: NCT00910689     History of Changes
Other Study ID Numbers: 2RO1NS32374, NS32374
Study First Received: November 24, 2008
Results First Received: November 24, 2008
Last Updated: June 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio University:
Migraine Headache
Preventive Therapy
Beta Blocker Medication
Behavior Therapy
Clinical Trial

Additional relevant MeSH terms:
Migraine Disorders
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Adrenergic beta-Antagonists
Propranolol
Nadolol
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013