A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)

NCT01657370 | Completed Phase 2 Results

• 1 other identifier: 1602-007
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day

  2 hours post dose 1

• Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day

  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

  2-24 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

Other Outcomes (3)

• 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

• Plasma MK-1602 Concentrations at Visit 2 (Day 4)

  Up to 3.5 hours post dose 3

Study Arms (6)

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.

Drug: Placebo; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

MK-1602 50 mg

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

Interventions

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.

MK-1602 1 mg; MK-1602 10 mg; MK-1602 100 mg; MK-1602 25 mg; MK-1602 50 mg

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.

Placebo

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.

MK-1602 1 mg; MK-1602 10 mg; MK-1602 100 mg; MK-1602 25 mg; MK-1602 50 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

ubrogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 9, 2016
• Results First Posted: December 9, 2016

Record last verified: 2016-10