MigrainePhase 2NCT01657370

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

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 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. 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: 195 participants
Where: No sites listed yet
Study dates: Aug 2012to 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 36Show 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 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

About this study

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

Conditions: Migraine
Being tested: MK-1602, Placebo, 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
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.
PlaceboDrug
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 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, opiates or other medication not explicitly excluded.

Study groups in NCT01657370
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: MK-1602; Drug: Rescue medication

What is being measured

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

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.
Measured: 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.
Measured: 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.
Measured: 2 hours post dose 1

Secondary outcomes (7)

Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day
Phonophobia is sensitivity to sound.
Measured: 2 hours post dose 1
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day
Photophobia is sensitivity to light.
Measured: 2 hours post dose 1
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-24 hours post dose 1

Timeline

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

Aug 2012Dec 2012

First posted6 Aug 2012 (estimated)
Study startAug 2012
Primary completionNov 2012
Study completionDec 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.
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: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01657370
Sponsor's protocol ID: 1602-007
Status last verified: Oct 2016
First submitted: 2 Aug 2012
Last updated: 9 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine
ClinicalTrials.gov ID: NCT01657370
Acronym / sponsor ID: 1602-007
Conditions: Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 6 Aug 2012 (estimated)
Results: Posted 9 Dec 2016

Clinical summary

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

Study design

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

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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	Experimental	Drug: MK-1602, Drug: Rescue medicationMK-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	Drug: MK-1602, Drug: Rescue medicationMK-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.

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 (36 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-1602Three 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.	Drug	MK-1602 1 mg, MK-1602 10 mg, MK-1602 100 mg, MK-1602 25 mg, MK-1602 50 mg
PlaceboThree 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.	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, opiates 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

Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 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.
Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 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
Time frame: 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.

7 secondary outcomes

Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 2 hours post dose 1
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 2 hours post dose 1
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 2 hours post dose 1
Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day
Time frame: 2-24 hours post dose 1
Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day
Time frame: 2-24 hours post dose 1
Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day
Time frame: 2 hours post dose 1
Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day
Time frame: 2-24 hours post dose 1

Results and safety

Results posted to the registry on 9 Dec 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	33	27
MK-1602 1 mg	32	28
MK-1602 10 mg	32	25
MK-1602 25 mg	33	28
MK-1602 50 mg	34	27
MK-1602 100 mg	31	27

Primary outcome: Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day

Time frame: 2 hours post dose 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanomolar (nM)

Measure	MK-1602 1 mg n = 21	MK-1602 10 mg n = 23	MK-1602 25 mg n = 27	MK-1602 50 mg n = 22	MK-1602 100 mg n = 23
Value	1.9 (73)	17.0 (74)	43.8 (130)	52.7 (270)	184.8 (170)

Population analysed: Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.

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

Time frame: 2 hours post dose 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 28	MK-1602 1 mg n = 28	MK-1602 10 mg n = 26	MK-1602 25 mg n = 28	MK-1602 50 mg n = 28	MK-1602 100 mg n = 27
Value	0.0 (0.0 to 12.3)	0.0 (0.0 to 12.3)	3.8 (0.1 to 19.6)	17.9 (6.1 to 36.9)	28.6 (13.2 to 48.7)	11.1 (2.4 to 29.2)

Population analysed: 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.

Primary outcome: Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day

Time frame: 2 hours post dose 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 28	MK-1602 1 mg n = 28	MK-1602 10 mg n = 26	MK-1602 25 mg n = 28	MK-1602 50 mg n = 28	MK-1602 100 mg n = 27
Value	42.9 (24.5 to 62.8)	42.9 (24.5 to 62.8)	30.8 (14.3 to 51.8)	46.4 (27.5 to 66.1)	67.9 (47.6 to 84.1)	70.4 (49.8 to 86.2)

7 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 28 (0%)	6 of 28 (21.4%)	Not reported
MK-1602 1 mg	0 of 28 (0%)	6 of 28 (21.4%)	Not reported
MK-1602 10 mg	0 of 26 (0%)	2 of 26 (7.7%)	Not reported
MK-1602 25 mg	0 of 28 (0%)	10 of 28 (35.7%)	Not reported
MK-1602 50 mg	0 of 28 (0%)	7 of 28 (25%)	Not reported
MK-1602 100 mg	0 of 27 (0%)	7 of 27 (25.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine

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
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App-Based Migraine Treatment: The Health enSuite Study
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Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
Marine Lipids Ease Painful TMD
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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 36 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 9 Dec 2016. 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 9 Dec 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?

Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day (time frame: 2 hours post dose 1). The study lists 3 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 NCT01657370.

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 9 Dec 2016.