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The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment of acute migraine, including the influence of demographic and other variables on MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and efficacy of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 1 mg | Experimental | MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 10 mg | Experimental | MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 25 mg | Experimental | MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 50 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1602 | Drug | Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1). Dosage form is film coated tablet for oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay. | 2 hours post dose 1 |
| Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 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 1 |
| Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | PR was defined as a decrease from 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 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | Phonophobia is sensitivity to sound. | 2 hours post dose 1 |
| Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day |
| Measure | Description | Time Frame |
|---|---|---|
| Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day | Up to 24 hours post dose 1 | |
| Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4) | 3.5 hours post dose 3 | |
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 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
other circumstance that might confound the results of the study, or interfere with subject's participation for the full duration of the study
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, with the exception of MK-1602 Protocol 006
analgesic for migraine relief
attack within the past 2 months
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| FG001 | MK-1602 1 mg | MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| FG002 | MK-1602 10 mg | MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| FG003 | MK-1602 25 mg | MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| FG004 | MK-1602 50 mg | MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| FG005 | MK-1602 100 mg | MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. 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 | MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. 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, Customized | Number |
| 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 | Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay. | Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomolar (nM) | 2 hours post dose 1 |
|
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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 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 | MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | 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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| Experimental |
MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
| MK-1602 100 mg | Experimental | MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
|
| Placebo | Drug | Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1). Dosage form is film coated tablet for oral administration. |
|
| 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, opiates or other medication not explicitly excluded. |
|
Photophobia is sensitivity to light. |
| 2 hours post dose 1 |
| Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 |
| Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 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 2-24 hour period after dosing with study medication. | 2-24 hours post dose 1 |
| Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 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 2-24 hour period after dosing with study medication. | 2-24 hours post dose 1 |
| Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 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 1 |
| Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication. | 2-24 hours post dose 1 |
| Plasma MK-1602 Concentrations at Visit 2 (Day 4) |
| Up to 3.5 hours post dose 3 |
| Physician Decision |
|
| Lack of Qualifying Event |
|
| Adverse Event |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| BG002 | MK-1602 10 mg | MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| BG003 | MK-1602 25 mg | MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| BG004 | MK-1602 50 mg | MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| BG005 | MK-1602 100 mg | MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MK-1602 10 mg |
MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| OG002 | MK-1602 25 mg | MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| OG003 | MK-1602 50 mg | MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
| OG004 | MK-1602 100 mg | MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. |
|
|
| Primary | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 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. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post dose 1 |
|
|
|
| Primary | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | PR was defined as a decrease from 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. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | Phonophobia is sensitivity to sound. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | Photophobia is sensitivity to light. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 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 2-24 hour period after dosing with study medication. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-24 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 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 2-24 hour period after dosing with study medication. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-24 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 hours post dose 1 |
|
|
|
| Secondary | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication. | Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point. | Posted | Number | 95% Confidence Interval | percentage of participants | 2-24 hours post dose 1 |
|
|
|
| Other Pre-specified | Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day | As per protocol, only listings of individual DBS for MK-1602 over time were produced. No formal non-compartmental Pharmacokinetic (PK) analysis was done for this outcome measure. | Posted | Up to 24 hours post dose 1 |
|
|
| Other Pre-specified | Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4) | As per protocol, only listings of individual DBS concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure. | Posted | 3.5 hours post dose 3 |
|
|
| Other Pre-specified | Plasma MK-1602 Concentrations at Visit 2 (Day 4) | As per protocol, only listings of individual plasma concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure. | Posted | Up to 3.5 hours post dose 3 |
|
|
| 0 |
| 28 |
| 6 |
| 28 |
| EG001 | MK-1602 1 mg | MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. | 0 | 28 | 6 | 28 |
| EG002 | MK-1602 10 mg | MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. | 0 | 26 | 2 | 26 |
| EG003 | MK-1602 25 mg | MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. | 0 | 28 | 10 | 28 |
| EG004 | MK-1602 50 mg | MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. | 0 | 28 | 7 | 28 |
| EG005 | MK-1602 100 mg | MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary. | 0 | 27 | 7 | 27 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | 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 |