Chronic MigrainePhase 3CMTTNCT00772031

NINDS CRC Chronic Migraine Treatment Trial

A Phase 3 study testing propranolol LA and topiramate in people with Chronic Migraine, run by Anne Lindblad at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Migraine
What is being tested?: propranolol LA and topiramate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 191 participants
Where: 39 sitesUnited States
Study dates: Oct 2008to Sep 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

United States39 sites

Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301
Abington, Pennsylvania, 19001
Dent Neurologic Institute, 3980 Sheridan Drive
Amherst, New York, 14226
ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M
Ann Arbor, Michigan, 48106
Mission Neurology, Research Institute Mission Hospital, 509 Biltmore
Asheville, North Carolina, 28801
Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302
Bethlehem, Pennsylvania, 18015
Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105
Boca Raton, Florida, 33432
Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B
Chico, California, 95926
Southeast Clinical Research, LLC, 304 NE 1st Street
Chiefland, Florida, 32626
Shanti Clinical Trials, 1880 West Washington Street
Colton, California, 92324
Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower
Dallas, Texas, 75214
Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B
Edison, New Jersey, 08817
Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.
Fort Wayne, Indiana, 46804
Guilford Neurologic Associates, 1126 North Church Street, Suite 200
Greensboro, North Carolina, 27401
Houston Headache Clinic, 1213 Hermann Drive, Suite 820
Houston, Texas, 77004
Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525
Houston, Texas, 77063
Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200
Hurst, Texas, 76054
NervPro Research, 15825 Laguna Canyon Road, Suite 202
Irvine, California, 92618
Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002
La Crosse, Wisconsin, 54601
MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100
Lenexa, Kansas, 66214
Trover Health System Center for Clinical Studies, 200 Clinic Drive
Madisonville, Kentucky, 42431
Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417
Miami, Florida, 33161
West Virginia University 1 Medical Center Dr, Box 9180
Morgantown, West Virginia, 26506 - 9180
New England Center for Clinical Research (NECCR), 52 Brigham St #7
New Bedford, Massachusetts, 02740
Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B
Ormond Beach, Florida, 32174
Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130
Philadelphia, Pennsylvania, 19107
Mayo Clinic 5777 E Mayo Blvd
Phoenix, Arizona, 85054
Island Neurological Associates, PC, 824 Old Country Road
Plainview, New York, 11803
Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11
Ponte Vedra, Florida, 32082
Mercy Medical Group- CHWMF 3000 Q Street, Neurology
Sacramento, California, 95816
Schenectady Neurological Consultants 1401 Union Street
Schenectady, New York, 12308
Swedish Pain & Headache Center 101 Madison St, Suite 200
Seattle, Washington, 98116
Dr. B. Abraham, P.C. 3020 Highway 124
Snellville, Georgia, 30039
Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101
South Jordan, Utah, 84095
Neurology Clinical Research, Inc, 3540 North Pine Island Rd
Sunrise, Florida, 33351
Montefiore Headache Center 1575 Blondell Avenue Ste 225
The Bronx, New York, 10461
Progress Clinical Trials, 707 Kings Lane
Tullahoma, Tennessee, 37388
Paradigm Clinical, Inc. 1324 W. Prince Rd
Tuscon, Arizona, 85705
ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J
West Chester, Ohio, 45069
New England Regional Headache Center, Inc 85 Prescott St, Ste 101
Worcester, Massachusetts, 01605-2982

Other trials in United States

About this study

Official title: NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial

Read the 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.

Conditions: Chronic Migraine
Being tested: propranolol LA, topiramate, placebo
Keywords: chronic migraine, migraine prevention, chronic headache
Medical subject headings: Headache Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propranolol LADrug
Also called Inderal LA
Propranolol LA up to 240 mg/day
topiramateDrug
Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.
placeboDrug
an inactive substance

Study groups in NCT00772031
Study group	Role	What they receive
1	Active comparator	Participants will receive propranolol and topiramate. Receives: Drug: propranolol LA; Drug: topiramate
2	Placebo comparator	Participants will receive a placebo and topiramate. Receives: Drug: topiramate; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline
(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).
Measured: Baseline (pre-randomization), months 5 and 6 post randomization

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Sep 2010

First posted15 Oct 2008 (estimated)
Study startOct 2008
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772031
Sponsor's protocol ID: 08-CRC-01
Other IDs: HHSN265200523641C
Acronym: CMTT
Status last verified: Jan 2012
First submitted: 14 Oct 2008
Last updated: 24 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial
ClinicalTrials.gov ID: NCT00772031
Acronym / sponsor ID: CMTT / 08-CRC-01
Conditions: Chronic Migraine
Keywords: chronic migraine, migraine prevention, chronic headache
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Anne LindbladIndustry (pharma, biotech, devices)
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Ortho-McNeil Janssen Scientific Affairs, LLC
Study start: Oct 2008
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 19 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: propranolol LA, Drug: topiramateParticipants will receive propranolol and topiramate.
2	Placebo comparator	Drug: topiramate, Drug: placeboParticipants will receive a placebo and topiramate.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
propranolol LAAlso: Inderal LAPropranolol LA up to 240 mg/day	Drug	1
topiramateTopiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.	Drug	1, 2
placeboan inactive substance	Drug	2

Primary outcome

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).

7 secondary outcomes

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

Results and safety

Results posted to the registry on 19 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Topiramate Plus Propranolol	96	64
Topiramate Plus Placebo	95	52

Primary outcome: 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. Mean (Standard Deviation). Unit: Moderate to severe headache days

Measure	Topiramate Plus Propranolol n = 63	Topiramate Plus Placebo n = 48
Value	4.4 (5.98)	4.7 (5.66)

Topiramate Plus Propranolol vs Topiramate Plus Placebo: Mean Difference (Net): 0.3 (95% CI -1.8 to 2.4), p = 0.77, ANCOVA

Population analysed: ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Topiramate Plus Propranolol	7 of 96 (7.3%)	59 of 96 (61.5%)	Not reported
Topiramate Plus Placebo	5 of 95 (5.3%)	50 of 95 (52.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Migraine

Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
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RecruitingPhase 2
Study of EVO756 in Adults With Migraine
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Dodick, MD principal investigator

Professor of Neurology, Mayo Clinic

Stephen D. Silberstein, MD principal investigator

Professor of Neurology, Thomas Jefferson University

Deborah Hirtz, MD principal investigator

National Institute of Neurological Disorders and Stroke (NINDS)

39 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing propranolol LA and topiramate in people with Chronic Migraine, run by Anne Lindblad at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00772031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.