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Completed

NCT Number: NCT00772031

NINDS CRC Chronic Migraine Treatment Trial

The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic 5777 E Mayo Blvd, Phoenix, Arizona, United States

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About this study

Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate is becoming the standard treatment among headache specialists. Experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. No randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine.

The goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. In the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. Participants will be followed for six months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of chronic migraine for at least 6 months
  • Age ≥ 18 years and age of migraine onset 60 or younger
  • EKG performed in the last 12 months

Exclusion criteria

  • Prior neuro-imaging suggesting secondary structural causes of headache
  • Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder
  • Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)
  • History of kidney failure or nephrolithiasis
  • A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control
  • Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month
  • Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol
  • Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months

Treatment and study plan

propranolol LA

Drug

Propranolol LA up to 240 mg/day

Other names: Inderal LA

Topiramate

Drug

Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.

Placebo

Drug

an inactive substance

Primary outcomes

  1. Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline

    Time frame: Baseline (pre-randomization), months 5 and 6 post randomization

    (Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).

Secondary outcomes

  1. Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days

    Time frame: 6 months post randomization

  2. Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days

    Time frame: 6 months

  3. Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months

    Time frame: Baseline and 6 months

    Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).

  4. Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months

    Time frame: Baseline and 6 months

    MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).

  5. Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months

    Time frame: baseline and 6 months post randomization

    The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.

  6. Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months

    Time frame: Baseline and 6 months

    The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.

  7. Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months

    Time frame: Baseline and 6 Months

    The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.

Sponsors and collaborators

Lead sponsor

Anne Lindblad

Industry

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Ortho-McNeil Janssen Scientific Affairs, LLC

Registry information

Official study title

NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial

Acronym: CMTT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2008
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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