NINDS CRC Chronic Migraine Treatment Trial

Phase 3

Completed

Conditions: Chronic Migraine

Interventions: Drug: propranolol LA
Drug: placebo
Drug: topiramate

Registration Number: NCT00772031

Lead Sponsor: Anne Lindblad

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 191

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	propranolol LA	Participants will receive propranolol and topiramate.
2	placebo	Participants will receive a placebo and topiramate.
1	topiramate	Participants will receive propranolol and topiramate.
2	topiramate	Participants will receive a placebo and topiramate.

Primary Outcome Measures

Name	Time	Method
Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline	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 Outcome Measures

Name	Time	Method
Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days	6 months post randomization
Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days	6 months
Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months	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).
Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months	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).
Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months	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.
Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months	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.
Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months	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.

Trial Locations

Locations (39): Mayo Clinic 5777 E Mayo Blvd
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Phoenix, Arizona, United States
Paradigm Clinical, Inc. 1324 W. Prince Rd
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Tuscon, Arizona, United States
Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B
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Chico, California, United States
Shanti Clinical Trials, 1880 West Washington Street
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Colton, California, United States
NervPro Research, 15825 Laguna Canyon Road, Suite 202
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Irvine, California, United States
Mercy Medical Group- CHWMF 3000 Q Street, Neurology
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Sacramento, California, United States
Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105
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Boca Raton, Florida, United States
Southeast Clinical Research, LLC, 304 NE 1st Street
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Chiefland, Florida, United States
Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417
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Miami, Florida, United States
Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B
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Ormond Beach, Florida, United States
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Mayo Clinic 5777 E Mayo Blvd
🇺🇸Phoenix, Arizona, United States