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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN265200523641C | Other Identifier | NINDS Contract |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Participants will receive propranolol and topiramate. |
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| 2 | Placebo Comparator | Participants will receive a placebo and topiramate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propranolol LA | Drug | Propranolol LA up to 240 mg/day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (pre-randomization), months 5 and 6 post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Dodick, MD | Professor of Neurology, Mayo Clinic | Principal Investigator |
| Stephen D. Silberstein, MD | Professor of Neurology, Thomas Jefferson University | Principal Investigator |
| Deborah Hirtz, MD | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic 5777 E Mayo Blvd | Phoenix | Arizona | 85054 | United States | ||
| Paradigm Clinical, Inc. 1324 W. Prince Rd |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate Plus Propranolol | Participants will receive propranolol and topiramate. |
| FG001 | Topiramate Plus Placebo | Participants will receive a placebo and topiramate. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
|
| 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). | 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). | 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. | 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. | 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. | Baseline and 6 Months |
| Tuscon |
| Arizona |
| 85705 |
| United States |
| Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B | Chico | California | 95926 | United States |
| Shanti Clinical Trials, 1880 West Washington Street | Colton | California | 92324 | United States |
| NervPro Research, 15825 Laguna Canyon Road, Suite 202 | Irvine | California | 92618 | United States |
| Mercy Medical Group- CHWMF 3000 Q Street, Neurology | Sacramento | California | 95816 | United States |
| Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105 | Boca Raton | Florida | 33432 | United States |
| Southeast Clinical Research, LLC, 304 NE 1st Street | Chiefland | Florida | 32626 | United States |
| Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417 | Miami | Florida | 33161 | United States |
| Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B | Ormond Beach | Florida | 32174 | United States |
| Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11 | Ponte Vedra | Florida | 32082 | United States |
| Neurology Clinical Research, Inc, 3540 North Pine Island Rd | Sunrise | Florida | 33351 | United States |
| Dr. B. Abraham, P.C. 3020 Highway 124 | Snellville | Georgia | 30039 | United States |
| Ft. Wayne Neurological Center 7956 W. Jefferson Blvd. | Fort Wayne | Indiana | 46804 | United States |
| MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100 | Lenexa | Kansas | 66214 | United States |
| Trover Health System Center for Clinical Studies, 200 Clinic Drive | Madisonville | Kentucky | 42431 | United States |
| New England Center for Clinical Research (NECCR), 52 Brigham St #7 | New Bedford | Massachusetts | 02740 | United States |
| New England Regional Headache Center, Inc 85 Prescott St, Ste 101 | Worcester | Massachusetts | 01605-2982 | United States |
| ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M | Ann Arbor | Michigan | 48106 | United States |
| Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B | Edison | New Jersey | 08817 | United States |
| Dent Neurologic Institute, 3980 Sheridan Drive | Amherst | New York | 14226 | United States |
| Island Neurological Associates, PC, 824 Old Country Road | Plainview | New York | 11803 | United States |
| Schenectady Neurological Consultants 1401 Union Street | Schenectady | New York | 12308 | United States |
| Montefiore Headache Center 1575 Blondell Avenue Ste 225 | The Bronx | New York | 10461 | United States |
| Mission Neurology, Research Institute Mission Hospital, 509 Biltmore | Asheville | North Carolina | 28801 | United States |
| Guilford Neurologic Associates, 1126 North Church Street, Suite 200 | Greensboro | North Carolina | 27401 | United States |
| ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J | West Chester | Ohio | 45069 | United States |
| Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301 | Abington | Pennsylvania | 19001 | United States |
| Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302 | Bethlehem | Pennsylvania | 18015 | United States |
| Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130 | Philadelphia | Pennsylvania | 19107 | United States |
| Progress Clinical Trials, 707 Kings Lane | Tullahoma | Tennessee | 37388 | United States |
| Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower | Dallas | Texas | 75214 | United States |
| Houston Headache Clinic, 1213 Hermann Drive, Suite 820 | Houston | Texas | 77004 | United States |
| Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525 | Houston | Texas | 77063 | United States |
| Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200 | Hurst | Texas | 76054 | United States |
| Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101 | South Jordan | Utah | 84095 | United States |
| Swedish Pain & Headache Center 101 Madison St, Suite 200 | Seattle | Washington | 98116 | United States |
| West Virginia University 1 Medical Center Dr, Box 9180 | Morgantown | West Virginia | 26506 - 9180 | United States |
| Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002 | La Crosse | Wisconsin | 54601 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate Plus Propranolol | Participants will receive propranolol and topiramate. |
| BG001 | Topiramate Plus Placebo | Participants will receive a placebo and topiramate. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | Moderate to severe headache days | Baseline (pre-randomization), months 5 and 6 post randomization |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days | All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure | Posted | Number | participants | 6 months post randomization |
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| Secondary | Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days | All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months | Posted | Number | participants | 6 months |
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| Secondary | 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). | The number who completed the Beck's Depression Inventory at baseline and three months | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| Secondary | 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). | per protocol | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| Secondary | 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. | per protocol | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months post randomization |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 Months |
|
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6 months
Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topiramate Plus Propranolol | Participants will receive propranolol and topiramate. | 7 | 96 | 59 | 96 | ||
| EG001 | Topiramate Plus Placebo | Participants will receive a placebo and topiramate. | 5 | 95 | 50 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA(13.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA(13.0) | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA(13.0) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA(13.0) | Systematic Assessment |
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| Upper Abdominal Pain | Gastrointestinal disorders | MedDRA(13.0) | Non-systematic Assessment |
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| Breast Pain | Reproductive system and breast disorders | MedDRA(13.0) | Non-systematic Assessment |
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| Breast Mass | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (13.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Pelvic Pain | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Colporrhaphy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Mental Impairment | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Any Vascular Disorder | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne S Lindblad, PhD | The EMMES Corporation | 301 251 1161 | 105 | alindblad@emmes.com |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
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| >=65 years |
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| Male |
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| No |
| Superiority or Other |
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| OG003 |
| Topiramate Plus Placebo, Prior, Stable Topiramate |
Participants with prior stable topiramate use received a placebo and topiramate. |
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