MigrainePhase 2NCT01613248

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

A Phase 2 study testing MK-1602 and Rescue medication in people with Migraine, run by Allergan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: MK-1602 and Rescue medication
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 834 participants
Where: No sites listed yet
Study dates: 1 Jul 2012to 1 Dec 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

> 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

Who cannot join

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

Show all 35Show fewer

> 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)
Clinical or laboratory evidence of uncontrolled diabetes, human immunodeficiency virus (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
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
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

About this study

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine

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
Being tested: MK-1602, Placebo-matching MK-1602, Rescue medication
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-1602Drug
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.
Placebo-matching MK-1602Drug
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 medicationDrug
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.

Study groups in NCT01613248
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo-matching MK-1602; Drug: Rescue medication

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 14 days post-dose
Number of Participants Who Discontinued From Study Due to Adverse Events
Measured: Up to 5 weeks post-dose

Secondary outcomes (10)

Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
Phonophobia is sensitivity to loud sounds.
Measured: 2 hours post-dose
Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
Photophobia is sensitivity to bright light.
Measured: 2 hours post-dose
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20121 Dec 2012

First posted7 Jun 2012 (estimated)
Study start1 Jul 2012
Primary completion1 Dec 2012
Study completion1 Dec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 834 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01613248
Sponsor's protocol ID: 1602-006
Status last verified: Dec 2018
First submitted: 16 May 2012
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27269043
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.
PubMed 39982105

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine
ClinicalTrials.gov ID: NCT01613248
Acronym / sponsor ID: 1602-006
Conditions: Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 834 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Jul 2012 (actual)
Primary completion: 1 Dec 2012 (actual)
Study completion: 1 Dec 2012 (actual)
First posted: 7 Jun 2012 (estimated)
Results: Posted 30 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
MK-1602 1 mg	Experimental	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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.
Placebo	Placebo comparator	Drug: Placebo-matching MK-1602, Drug: Rescue medicationPlacebo-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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

> 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

Key exclusion criteria (35 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-1602Single 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.	Drug	MK-1602 1 mg, MK-1602 10 mg, MK-1602 100 mg, MK-1602 25 mg, MK-1602 50 mg
Placebo-matching MK-1602Single 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.	Drug	Placebo
Rescue medicationIf 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.	Drug	MK-1602 1 mg, MK-1602 10 mg, MK-1602 100 mg, MK-1602 25 mg, MK-1602 50 mg, Placebo

Primary outcome

Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose
Time frame: 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.
Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose
Time frame: 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.
Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
Time frame: Up to 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.
Number of Participants With One or More Adverse Events Within 14 Days Post-Dose
Time frame: Up to 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.
Number of Participants Who Discontinued From Study Due to Adverse Events
Time frame: Up to 5 weeks post-dose

10 secondary outcomes

Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose
Time frame: 2-24 hours post-dose
Percentage of Participants Reporting SPF 2-48 Hours Post-Dose
Time frame: 2-48 hours post-dose
Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose
Time frame: 2-24 hours post-dose
Percentage of Participants Reporting SPR 2-48 Hours Post-Dose
Time frame: 2-48 hours post-dose
Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose
Time frame: 2-24 hours post-dose
Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose
Time frame: 2-48 hours post-dose

Results and safety

Results posted to the registry on 30 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	139	110
MK-1602 1 mg	138	104
MK-1602 10 mg	139	106
MK-1602 25 mg	139	101
MK-1602 50 mg	139	104
MK-1602 100 mg	140	102

Primary outcome: Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 112	MK-1602 1 mg n = 107	MK-1602 10 mg n = 108	MK-1602 25 mg n = 103	MK-1602 50 mg n = 105	MK-1602 100 mg n = 102
Value	8.9 (4.4 to 15.8)	5.6 (2.1 to 11.8)	14.8 (8.7 to 22.9)	21.4 (13.9 to 30.5)	21.0 (13.6 to 30.0)	25.5 (17.4 to 35.1)

Population analysed: 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.

Primary outcome: Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 112	MK-1602 1 mg n = 107	MK-1602 10 mg n = 108	MK-1602 25 mg n = 103	MK-1602 50 mg n = 105	MK-1602 100 mg n = 102
Value	44.6 (35.2 to 54.3)	37.4 (28.2 to 47.3)	52.8 (42.9 to 62.5)	53.4 (43.3 to 63.3)	57.1 (47.1 to 66.8)	58.8 (48.6 to 68.5)

Primary outcome: Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose

Time frame: Up to 48 hours post-dose. Number. Unit: participants

Measure	Placebo n = 113	MK-1602 1 mg n = 107	MK-1602 10 mg n = 108	MK-1602 25 mg n = 103	MK-1602 50 mg n = 107	MK-1602 100 mg n = 102
Value	28	33	29	21	23	30

Population analysed: All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.

Primary outcome: Number of Participants With One or More Adverse Events Within 14 Days Post-Dose

Time frame: Up to 14 days post-dose. Number. Unit: participants

Measure	Placebo n = 113	MK-1602 1 mg n = 107	MK-1602 10 mg n = 108	MK-1602 25 mg n = 103	MK-1602 50 mg n = 107	MK-1602 100 mg n = 102
Value	33	37	32	24	30	32

Population analysed: ASaT population included all randomized participants who received at least one dose of study treatment.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 113 (0%)	15 of 113 (13.3%)	Not reported
MK-1602 1 mg	0 of 107 (0%)	22 of 107 (20.6%)	Not reported
MK-1602 10 mg	0 of 108 (0%)	13 of 108 (12%)	Not reported
MK-1602 25 mg	0 of 104 (0%)	15 of 104 (14.4%)	Not reported
MK-1602 50 mg	1 of 106 (0.9%)	14 of 106 (13.2%)	Not reported
MK-1602 100 mg	0 of 102 (0%)	17 of 102 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27269043Voss 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.
Derived from this study: PubMed 39982105Goadsby 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-1602 and Rescue medication in people with Migraine, run by Allergan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose (time frame: 2 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01613248, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.