A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)

NCT01613248 | Completed Phase 2 Results

• 1 other identifier: 1602-006
• Study Type: interventional
• Target: 834
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (10)

• Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose

  2 hours post-dose

• Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose

  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

  2-24 hours post-dose

• Percentage of Participants Reporting SPF 2-48 Hours Post-Dose

  2-48 hours post-dose

Study Arms (6)

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: MK-1602; Drug: Rescue medication

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.

Drug: Placebo-matching MK-1602; Drug: Rescue medication

Interventions

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.

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

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.

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 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 will not be changed
• 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, 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)

Sponsors & Collaborators

• Allergan: lead

Related Publications (2)

• 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.

  PMID: 27269043 BACKGROUND

• 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.

  PMID: 39982105 DERIVED

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: May 16, 2012
• First Posted: June 7, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2019
• Results First Posted: September 30, 2016

Record last verified: 2018-12