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The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2 weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the initial randomization. In the Run-out Period, participants who received placebo in the Treatment Period continued to receive placebo and participants who received MK-6096 in the Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as measured by the mean change from baseline in monthly migraine days averaged over the 12- week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6096 | Experimental | Participants were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period were randomized 1:1 to receive double-blind MK-6096 or placebo once daily in the 2-week Run-out Period. |
|
| Placebo | Placebo Comparator | Participants were randomized to receive double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period continued to receive double-blind placebo once daily in the 2-week Run-out Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6096 | Drug | MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Monthly Migraine Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days. | Baseline and average over Treatment Period (Weeks 0-12) |
| Percentage of Participants With One or More Adverse Events | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only. | Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14 |
| Percentage of Participants Discontinued From Study Medication Due to an Adverse Event | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only. | Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Monthly Headache Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25106663 | Background | Chabi A, Zhang Y, Jackson S, Cady R, Lines C, Herring WJ, Connor KM, Michelson D. Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis. Cephalalgia. 2015 Apr;35(5):379-88. doi: 10.1177/0333102414544979. Epub 2014 Aug 8. |
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A total of 423 participants were screened. Of these, 237 participants completed screening and met the eligibility criteria, including the required number of migraine days during the Screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Period: MK-6096 | Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period |
| FG001 | Treatment Period: Placebo | Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period |
| FG002 | Run-out Period: MK-6096 / MK-6096 | Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period. |
| FG003 | Run-out Period: MK-6096 / Placebo | Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period. |
| FG004 | Run-out Period: Placebo / Placebo | Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Run-out Period |
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Baseline characteristics are reported for all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Period: MK-6096 | Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period |
| BG001 | Treatment Period: Placebo |
| 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, 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 | Mean Change From Baseline in Monthly Migraine Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days. | The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period. | Posted | Least Squares Mean | Standard Error | Days/month | Baseline and average over Treatment Period (Weeks 0-12) |
|
Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14.
All Patients as Treated included all randomized participants who received at least one dose of double-blind study treatment.
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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 | Treatment Period: MK-6096 | Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| C573816 | MK-6096 |
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| Placebo |
| Drug |
Placebo, 2 tablets, orally, once daily |
|
| Baseline and average over Treatment Period (Weeks 0-12) |
| Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model. | Baseline and average over Treatment Period (Weeks 0-12) |
| Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model. | Baseline and average over Treatment Period (Weeks 0-12) |
| Lack of Efficacy |
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| Lost to Follow-up |
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| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Randomized not treated |
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| COMPLETED |
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| NOT COMPLETED |
|
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Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Treatment Period: MK-6096 |
Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period |
| OG001 | Treatment Period: Placebo | Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period |
|
|
|
| Primary | Percentage of Participants With One or More Adverse Events | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only. | The population analyzed included all randomized participants who received at least one dose of double-blind study treatment. | Posted | Number | Percentage of participants | Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14 |
|
|
|
|
| Primary | Percentage of Participants Discontinued From Study Medication Due to an Adverse Event | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only. | The population analyzed included all randomized participants who received at least one dose of double-blind study treatment. | Posted | Number | Percentage of participants | Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14 |
|
|
|
|
| Secondary | Mean Change From Baseline in Monthly Headache Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days. | The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period. | Posted | Least Squares Mean | Standard Error | Days/month | Baseline and average over Treatment Period (Weeks 0-12) |
|
|
|
|
| Secondary | Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model. | The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and average over Treatment Period (Weeks 0-12) |
|
|
|
|
| Secondary | Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days | Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model. | The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and average over Treatment Period (Weeks 0-12) |
|
|
|
|
| 0 |
| 120 |
| 26 |
| 120 |
| EG001 | Treatment Period: Placebo | Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period | 0 | 115 | 10 | 115 |
| EG002 | Run-out Period: MK-6096 / MK-6096 | Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period. | 0 | 50 | 1 | 50 |
| EG003 | Run-out Period: MK-6096 / Placebo | Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period. | 0 | 47 | 4 | 47 |
| EG004 | Run-out Period: Placebo / Placebo | Participants who received placebo and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period. | 0 | 101 | 1 | 101 |
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |