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The purpose of this study is to assess the effectiveness, safety and tolerability of a range of doses of MK-1602 versus placebo in the treatment of acute migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1602 1 mg | Experimental | MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 10 mg | Experimental | MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 25 mg | Experimental | MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 50 mg | Experimental | MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 100 mg | Experimental | MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1602 | Drug | Single 1, 10, 25, 50 or 100 mg dose of MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve the various MK-1602 dose levels to be studied. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose | PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain. | 2 hours post-dose |
| Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose | PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain. | 2 hours post-dose |
| Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose | An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product. | Up to 48 hours post-dose |
| Number of Participants With One or More Adverse Events Within 14 Days Post-Dose | An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product. | Up to 14 days post-dose |
| Number of Participants Who Discontinued From Study Due to Adverse Events | Up to 5 weeks post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose | Phonophobia is sensitivity to loud sounds. | 2 hours post-dose |
| Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose |
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Inclusion Criteria:
the two months prior to screening
reproductive potential with a screening serum β-human chorionic gonadotropin (β-hCG) level consistent with a not-pregnant state, and who agrees to use acceptable contraception
Exclusion Criteria:
resolve spontaneously in less than two hours
has changed during the 3 months prior to screening and will not be changed
during the study
in response to 3 or more classes of drugs (prescription and over-the-counter)
surgery or banding), or presence of a disease that causes malabsorption
weeks of study, or intent to donate blood products or receive
blood products within 30 days of screening and throughout study
study
in a study with an investigational compound or device
analgesic for migraine relief
attack within the past 2 months
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27269043 | Background | Voss T, Lipton RB, Dodick DW, Dupre N, Ge JY, Bachman R, Assaid C, Aurora SK, Michelson D. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016 Aug;36(9):887-98. doi: 10.1177/0333102416653233. Epub 2016 Jun 6. | |
| 39982105 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| FG001 | MK-1602 1 mg | MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| FG002 | MK-1602 10 mg | MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| FG003 | MK-1602 25 mg | MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| FG004 | MK-1602 50 mg | MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| FG005 | MK-1602 100 mg | MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Subjects as Treated Population included all randomized participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| BG001 | MK-1602 1 mg |
| 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 | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose | PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post-dose |
|
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All Subjects as Treated Population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events (SAE) and Other Adverse Events.
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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 | Placebo | Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myoclonus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment | SAE: Myoclonus occurred 15 days post-dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000615620 | ubrogepant |
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|
| Placebo | Placebo Comparator | Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
|
|
| Placebo-matching MK-1602 | Drug | Single administration of placebo-matching MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve placebo study medication. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache. |
|
| Rescue medication | Drug | If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours, Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), anti-emetics, triptans or other medication not explicitly excluded. |
|
Photophobia is sensitivity to bright light.
| 2 hours post-dose |
| Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose | 2 hours post-dose |
| Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose | SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication. | 2-24 hours post-dose |
| Percentage of Participants Reporting SPF 2-48 Hours Post-Dose | SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication. | 2-48 hours post-dose |
| Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose | SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication. | 2-24 hours post-dose |
| Percentage of Participants Reporting SPR 2-48 Hours Post-Dose | SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication. | 2-48 hours post-dose |
| Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose | TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose. | 2 hours post-dose |
| Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose | TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication. | 2-24 hours post-dose |
| Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose | TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication. | 2-48 hours post-dose |
| Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Study Terminated by Sponsor |
|
| Physician Decision |
|
| Lack of Qualifying Event |
|
| Pregnancy |
|
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
| BG002 | MK-1602 10 mg | MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| BG003 | MK-1602 25 mg | MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| BG004 | MK-1602 50 mg | MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| BG005 | MK-1602 100 mg | MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MK-1602 1 mg |
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| OG002 | MK-1602 10 mg | MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| OG003 | MK-1602 25 mg | MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| OG004 | MK-1602 50 mg | MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
| OG005 | MK-1602 100 mg | MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. |
|
|
| Primary | Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose | PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post-dose |
|
|
|
| Primary | Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose | An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product. | All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment. | Posted | Number | participants | Up to 48 hours post-dose |
|
|
|
| Primary | Number of Participants With One or More Adverse Events Within 14 Days Post-Dose | An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product. | ASaT population included all randomized participants who received at least one dose of study treatment. | Posted | Number | participants | Up to 14 days post-dose |
|
|
|
| Primary | Number of Participants Who Discontinued From Study Due to Adverse Events | ASaT population included all randomized participants who received at least one dose of study treatment. | Posted | Number | participants | Up to 5 weeks post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose | Phonophobia is sensitivity to loud sounds. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post-dose |
|
|
|
| Secondary | Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose | Photophobia is sensitivity to bright light. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose | SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-24 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting SPF 2-48 Hours Post-Dose | SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-48 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose | SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-24 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting SPR 2-48 Hours Post-Dose | SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-48 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose | TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose | TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-24 hours post-dose |
|
|
|
| Secondary | Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose | TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication. | Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-48 hours post-dose |
|
|
|
| 0 |
| 113 |
| 15 |
| 113 |
| EG001 | MK-1602 1 mg | MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. | 0 | 107 | 22 | 107 |
| EG002 | MK-1602 10 mg | MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. | 0 | 108 | 13 | 108 |
| EG003 | MK-1602 25 mg | MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. | 0 | 104 | 15 | 104 |
| EG004 | MK-1602 50 mg | MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. | 1 | 106 | 14 | 106 |
| EG005 | MK-1602 100 mg | MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. | 0 | 102 | 17 | 102 |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009422 | Nervous System Diseases |