Migraine
Conditions
Brief summary
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.
Interventions
DRUGMK-1602
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.
DRUGPlacebo
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.
DRUGRescue medication
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* \> 1 year history of migraine with or without aura as defined by International Headache Society (IHS) criteria 1.1 and/or 1.2 * Migraines typically last between 4 to 72 hours, if untreated * ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in each of the two months prior to screening * Male, female who is not of reproductive potential, or female of 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
* Pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation * Participant has difficulty distinguishing his/her migraine attacks from tension-type headaches * History of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours * More than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the three months prior to screening * Basilar-type or hemiplegic migraine headache * \> 50 years old at age of migraine onset * Taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening and during the study * Taking a proton pump inhibitor (PPI) or a histamine receptor 2 (H2) blocker on a daily or near daily basis (\> 3 days per week) * Taking the following medications from 1 month prior to screening through study period: potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., cyclosporine, itraconazole, ketoconazole, fluconazole, erythromycin, clarithromycin, nefazodone, telithromycin, cimetidine, quinine, diltiazem, verapamil, modafinil and human immunodeficiency virus \[HIV\] protease inhibitors), moderate or marked CYP3A4 inducers (e.g., rifampicin, rifabutin, barbiturates \[e.g., phenobarbital and primidone\], systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, and St. Johns wort), or drugs with narrow therapeutic margins and potential for drug interactions in the CYP2C family (e.g., warfarin) * Participant is unable to refrain from consumption of grapefruit or grapefruit juice during study * History of hypersensitivity to, or has experienced a serious adverse event in response to 3 or more classes of drugs (prescription and over-the-counter) * Clinical or laboratory evidence of uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease * Other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine. Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled are eligible to participate * Participant is at imminent risk of self-harm * History of malignancy ≤ 5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * History of gastric or small intestinal surgery (including gastric bypass surgery or banding), or presence of a disease that causes malabsorption * History or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with subject's participation for the full duration of the study * Participant has recent history (within the last year) of drug or alcohol abuse or dependence or is a user of recreational or illicit drugs * Participant is legally or mentally incapacitated * Donation of blood products or phlebotomy of \> 300 ml within 8 weeks of study, or intent to donate blood products or receive blood products within 30 days of screening and throughout study * Intent to donate eggs or sperm within the projected duration of the study * Current participation in or participation within 30 days of screening in a study with an investigational compound or device, with the exception of MK-1602 Protocol 006 * Previous exposure to MK-0974 and/or MK-3207 * Use within the past 2 months of an opioid- or barbiturate-containing analgesic for migraine relief * Inpatient or emergency department treatment of an acute migraine attack within the past 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 | 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. |
| Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 | 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. |
| Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 2-24 hours post dose 1 | 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. |
| Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 | TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose. |
| Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 2-24 hours post dose 1 | 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. |
| Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 2-24 hours post dose 1 | 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. |
| Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 | Phonophobia is sensitivity to sound. |
| Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 2 hours post dose 1 | Photophobia is sensitivity to light. |
Other
| Measure | Time frame |
|---|---|
| Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day | Up to 24 hours post dose 1 |
| Plasma MK-1602 Concentrations at Visit 2 (Day 4) | Up to 3.5 hours post dose 3 |
| Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4) | 3.5 hours post dose 3 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 28 |
| 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. | 26 |
| 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. | 28 |
| 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. | 28 |
| 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. | 27 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Qualifying Event | 1 | 0 | 3 | 2 | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 2 | 3 | 1 | 2 | 5 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | MK-1602 1 mg | MK-1602 10 mg | MK-1602 25 mg | MK-1602 50 mg | MK-1602 100 mg |
|---|---|---|---|---|---|---|---|
| Age, Customized 20 to 29 years | 47 participants | 4 participants | 8 participants | 6 participants | 9 participants | 11 participants | 9 participants |
| Age, Customized <20 years | 4 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Age, Customized 30 to 39 years | 42 participants | 9 participants | 7 participants | 7 participants | 7 participants | 6 participants | 6 participants |
| Age, Customized 40 to 49 years | 44 participants | 9 participants | 9 participants | 7 participants | 7 participants | 6 participants | 6 participants |
| Age, Customized 50 to 59 years | 22 participants | 5 participants | 3 participants | 4 participants | 3 participants | 4 participants | 3 participants |
| Age, Customized 60 to 64 years | 3 participants | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants | 1 participants |
| Age, Customized >= 65 years | 3 participants | 0 participants | 0 participants | 2 participants | 0 participants | 1 participants | 0 participants |
| Sex: Female, Male Female | 140 Participants | 25 Participants | 26 Participants | 22 Participants | 23 Participants | 26 Participants | 18 Participants |
| Sex: Female, Male Male | 25 Participants | 3 Participants | 2 Participants | 4 Participants | 5 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 28 | 6 / 28 | 2 / 26 | 10 / 28 | 7 / 28 | 7 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 26 | 0 / 28 | 0 / 28 | 0 / 27 |
Outcome results
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.
Time frame: 2 hours post dose 1
Population: Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-1602 1 mg | Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | 1.9 nanomolar (nM) | Geometric Coefficient of Variation 73 |
| MK-1602 10 mg | Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | 17.0 nanomolar (nM) | Geometric Coefficient of Variation 74 |
| MK-1602 25 mg | Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | 43.8 nanomolar (nM) | Geometric Coefficient of Variation 130 |
| MK-1602 50 mg | Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | 52.7 nanomolar (nM) | Geometric Coefficient of Variation 270 |
| MK-1602 100 mg | Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day | 184.8 nanomolar (nM) | Geometric Coefficient of Variation 170 |
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.
Time frame: 2 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 10 mg | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 25 mg | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 3.8 percentage of participants |
| MK-1602 50 mg | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 17.9 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 28.6 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day | 11.1 percentage of participants |
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.
Time frame: 2 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 42.9 percentage of participants |
| MK-1602 10 mg | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 42.9 percentage of participants |
| MK-1602 25 mg | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 30.8 percentage of participants |
| MK-1602 50 mg | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 46.4 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 67.9 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day | 70.4 percentage of participants |
Secondary
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 2 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 67.9 percentage of participants |
| MK-1602 10 mg | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 57.1 percentage of participants |
| MK-1602 25 mg | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 69.2 percentage of participants |
| MK-1602 50 mg | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 57.1 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 82.1 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day | 74.1 percentage of participants |
Secondary
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day
Phonophobia is sensitivity to sound.
Time frame: 2 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 28.6 percentage of participants |
| MK-1602 10 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 42.9 percentage of participants |
| MK-1602 25 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 30.8 percentage of participants |
| MK-1602 50 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 42.9 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 57.1 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day | 44.4 percentage of participants |
Secondary
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day
Photophobia is sensitivity to light.
Time frame: 2 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 25.0 percentage of participants |
| MK-1602 10 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 25.0 percentage of participants |
| MK-1602 25 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 26.9 percentage of participants |
| MK-1602 50 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 28.6 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 46.4 percentage of participants |
| MK-1602 100 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day | 48.1 percentage of participants |
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.
Time frame: 2-24 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 10 mg | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 25 mg | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 3.8 percentage of participants |
| MK-1602 50 mg | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 10.7 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 14.3 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day | 3.7 percentage of participants |
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.
Time frame: 2-24 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 28.6 percentage of participants |
| MK-1602 10 mg | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 25.0 percentage of participants |
| MK-1602 25 mg | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 15.4 percentage of participants |
| MK-1602 50 mg | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 42.9 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 57.1 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day | 48.1 percentage of participants |
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.
Time frame: 2-24 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 10 mg | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 25 mg | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 50 mg | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 10.7 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 14.3 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day | 3.7 percentage of participants |
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.
Time frame: 2 hours post dose 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1602 1 mg | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 10 mg | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 25 mg | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 0.0 percentage of participants |
| MK-1602 50 mg | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 14.3 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 28.6 percentage of participants |
| MK-1602 100 mg | Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day | 7.4 percentage of participants |
Other Pre-specified
Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day
Time frame: Up to 24 hours post dose 1
Population: 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.
Other Pre-specified
Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)
Time frame: 3.5 hours post dose 3
Population: 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.
Other Pre-specified
Plasma MK-1602 Concentrations at Visit 2 (Day 4)
Time frame: Up to 3.5 hours post dose 3
Population: 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.