Expired Study
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Tuscon, Arizona 85705


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

08-CRC-01


NCT ID:

NCT00772031


Secondary ID:

HHSN265200523641C


Study Acronym:

CMTT


Brief Title:

NINDS CRC Chronic Migraine Treatment Trial


Official Title:

NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The EMMES Corporation


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

191


Enrollment Type:

Actual


Overall Contact Information

Official Name:David Dodick, MD
Principal Investigator
Professor of Neurology, Mayo Clinic

Study Dates

Start Date:October 2008
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 20, 2012
First Received Date:October 14, 2008
First Results Date:October 18, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months
Time Frame:Baseline and 6 Months
Safety Issues:False
Description: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, Emot
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months
Time Frame:Baseline and 6 months
Safety Issues:False
Description: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, Emot
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months
Time Frame:baseline and 6 months post randomization
Safety Issues:False
Description: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, Emot
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months
Time Frame:Baseline and 6 months
Safety Issues:False
Description: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 (
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months
Time Frame:Baseline and 6 months
Safety Issues:True
Description: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 s
Outcome Type:Secondary Outcome
Measure:Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days
Time Frame:6 months post randomization
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:(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 headach

Study Interventions

Intervention Type:Drug
Name:propranolol LA
Description:Propranolol LA up to 240 mg/day
Arm Name:1
Other Name:Inderal LA
Intervention Type:Drug
Name:topiramate
Description:Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.
Arm Name:1
Intervention Type:Drug
Name:placebo
Description:an inactive substance
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Participants will receive propranolol and topiramate.
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Participants will receive a placebo and topiramate.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Anne Lindblad
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Neurological Disorders and Stroke (NINDS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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