- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613248
A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)
A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MK-1602 1 mg
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.
|
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.
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. |
EXPERIMENTAL: MK-1602 10 mg
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.
|
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.
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. |
EXPERIMENTAL: MK-1602 25 mg
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.
|
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.
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. |
EXPERIMENTAL: MK-1602 50 mg
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.
|
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.
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. |
EXPERIMENTAL: MK-1602 100 mg
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.
|
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.
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. |
PLACEBO_COMPARATOR: Placebo
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours post-dose
|
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.
|
2 hours post-dose
|
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.
|
Up to 48 hours post-dose
|
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.
|
Up to 14 days post-dose
|
Number of Participants Who Discontinued From Study Due to Adverse Events
Time Frame: Up to 5 weeks post-dose
|
Up to 5 weeks post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
Time Frame: 2 hours post-dose
|
Phonophobia is sensitivity to loud sounds.
|
2 hours post-dose
|
Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
Time Frame: 2 hours post-dose
|
Photophobia is sensitivity to bright light.
|
2 hours post-dose
|
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
Time Frame: 2 hours post-dose
|
2 hours post-dose
|
|
Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose
Time Frame: 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.
|
2-24 hours post-dose
|
Percentage of Participants Reporting SPF 2-48 Hours Post-Dose
Time Frame: 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.
|
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
|
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.
|
2-24 hours post-dose
|
Percentage of Participants Reporting SPR 2-48 Hours Post-Dose
Time Frame: 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.
|
2-48 hours post-dose
|
Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose
Time Frame: 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.
|
2 hours post-dose
|
Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose
Time Frame: 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.
|
2-24 hours post-dose
|
Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose
Time Frame: 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.
|
2-48 hours post-dose
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1602-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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