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| Name | Class |
|---|---|
| Avanir Pharmaceuticals | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and effectiveness of daily dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic migraine.
This is a double-blind, placebo-controlled, randomized, multi-center study to be conducted at the Headache Care Center in Springfield, MO and two other clinics in the United States. Approximately 45 subjects, 18 to 65 years of age, with frequent episodic migraine (6-14 days per month), with (1.2) or without aura (1.1) as defined by ICHD-3beta, will enter a 1-month baseline period to confirm the migraine diagnosis, as well as establish baseline characteristics. At Visit 1, subjects must not have a history of utilization of acute treatment greater than 14 days per month in the preceding 3 month period. Subjects must have a current history of ICHD-3beta migraine with 6-14 migraine days per month in the 3 months prior to the study enrollment. Eligible subjects will be randomly assigned to one of two groups in a 1:1 ratio. Randomization will occur using a computer-generated allocation schedule. Subjects meeting entrance criteria as determined both at screening and through the review of the baseline headache diary will be given the lowest available allocation number for that site. Migraine preventative use is permitted if the subject has been on a stable does for at least 2 months prior to screening and has not failed more than 3 migraine preventatives due to lack of efficacy. The study will consist of 5 office visits per subject: Visit 1 - screening, Visit 2 - randomization, and Visits 3 to 5 - three-month treatment period. During the baseline period, the subject will treat migraines with their current preferred acute treatment of choice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nuedexta | Active Comparator | One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. |
|
| Placebo | Placebo Comparator | One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan and quinidine | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Days in Each Treatment Period Month | The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period. | Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116) |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Days in Treatment Period Month 3 | The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period. | End of Treatment Period Month 3 (Day 116) |
| Migraine Days in Each Treatment Period Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish American Neuro and Headache Center | Rockford | Illinois | 61104 | United States | ||
| The Headache Center |
A total of 90 participants were screened, 14 failed to meet the inclusion criteria and were screen failed. 76 participants were enrolled into a 28-day run-in period. 31 were excluded from the study prior to being assigned to a treatment arm, due to failure to meet inclusion criteria. A total of 45 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nuedexta | One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Dextromethorphan and quinidine |
| FG001 | Placebo | One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nuedexta | One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Dextromethorphan and quinidine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Headache Days in Each Treatment Period Month | The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure. | Posted | Mean | Standard Deviation | Number of Headache days | Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116) |
|
116 days
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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 | Nuedexta | One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Dextromethorphan and quinidine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim Sly | Clinvest Research | 4178413673 | jsly@clinvest.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2016 | Jan 31, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 20, 2016 | Jan 31, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C507057 | dextromethorphan - quinidine combination |
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| Drug |
|
The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. |
| Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
| Headache Severity in Each Treatment Period Month | The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain. | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
| Headache Duration in Each Treatment Period Month | The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours. | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
| 50% Headache Reduction | The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm. | Baseline (Day 0) to Treatment Period Month 3 (Day 116) |
| Acute Medication Use in Each Treatment Period Month | The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
| Migraine Disability Assessment Scale (MIDAS) | MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) "how many days in the last 3 months..." questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following: 0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability | Visit 2 (Day 28) to Visit 5 (Day 116) |
| Headache Health Score | Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life. | Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) |
| Adverse Events | Compare the number of adverse events in the Nuedexta arm vs. the placebo arm. | Baseline (Day 0) to Treatment Period Month 3 (Day 116) |
| Ridgeland |
| Mississippi |
| 39157 |
| United States |
| StudyMetrix Research, LLC | City of Saint Peters | Missouri | 63303 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| Island Neurological Associates, PC | Plainview | New York | 11803 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Placebo |
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Headache Days | Number of headache days reported during the 28 day run-in period. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement. | Mean | Standard Deviation | Number of Headache Days |
|
| Migraine Days | Number of migraine days reported during the 28 day run-in period. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement. | Mean | Standard Deviation | Number of Migraine days |
|
| Headache Severity | Headache pain severity reported during the 28 day run-in period. Measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement. | Mean | Standard Deviation | units on a scale |
|
| Headache Duration | Average headache duration reported during the 28 day run-in period, measured in hours. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement. | Mean | Standard Deviation | Hours |
|
| Acute Medication Use | Number of doses of acute medication taken, reported during the 28 day run-in period. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement. | Mean | Standard Deviation | Number of medications |
|
| OG001 | Placebo | One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Placebo |
|
|
| Secondary | Headache Days in Treatment Period Month 3 | The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure. | Posted | Mean | Standard Deviation | Number of headache days | End of Treatment Period Month 3 (Day 116) |
|
|
|
| Secondary | Migraine Days in Each Treatment Period Month | The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure. | Posted | Mean | Standard Deviation | Number of Migraine days | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
|
|
|
| Secondary | Headache Severity in Each Treatment Period Month | The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets. | Posted | Mean | Standard Deviation | units on a scale | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
|
|
|
| Secondary | Headache Duration in Each Treatment Period Month | The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets. | Posted | Mean | Standard Deviation | Hours | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
|
|
|
| Secondary | 50% Headache Reduction | The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure. | Posted | Count of Participants | Participants | Baseline (Day 0) to Treatment Period Month 3 (Day 116) |
|
|
|
| Secondary | Acute Medication Use in Each Treatment Period Month | The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. | Posted | Mean | Standard Deviation | Number of medication doses | Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116) |
|
|
|
| Secondary | Migraine Disability Assessment Scale (MIDAS) | MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) "how many days in the last 3 months..." questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following: 0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. | Posted | Mean | Standard Deviation | units on a scale | Visit 2 (Day 28) to Visit 5 (Day 116) |
|
|
|
| Secondary | Headache Health Score | Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life. | Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. | Posted | Mean | Standard Deviation | units on a scale | Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) |
|
|
|
| Secondary | Adverse Events | Compare the number of adverse events in the Nuedexta arm vs. the placebo arm. | Posted | Number | Number of Adverse Events | Baseline (Day 0) to Treatment Period Month 3 (Day 116) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 4 |
| 22 |
| EG001 | Placebo | One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months. Placebo | 0 | 23 | 1 | 23 | 9 | 23 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Treatment Month 3 |
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| Treatment Month 3 |
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| Treatment Month 3 |
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| Treatment Month 3 |
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| Treatment Month 3 |
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| Visit 4 (Day 85) |
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| Visit 5 (Day 116) |
|