MigrainePhase 2NCT01513291
A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)
A Phase 2 study testing MK-6096 in people with Migraine and Headache, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- What is being tested?
- MK-6096
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2012to 3 Oct 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of migraine with or without aura for >1 year and with ≥4 and ≤14 migraine days per month in the 3 months prior to study
- Male, female not of reproductive potential, or female of reproductive potential who is not pregnant by pregnancy test and agrees to use acceptable contraception
Who cannot join
- Pregnancy, breast-feeding, or expecting to become pregnant
- Planning to donate egg or sperm during the study or within 90 days after last dose of study medication
- Basilar or hemiplegic migraine headache
- >50 years old at the age of migraine onset
- ≥15 headache-days per month or medication taken for acute migraine or other headaches on more than 10 days per month in any of the three months prior to study
- Migraine prophylactic medication (defined as medication taken daily to prevent migraines) taken in the 30 days prior to study
Show all 18Show fewer
- History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition (e.g., asthma, gastroesophageal reflux disease, etc.)
- Clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension, uncontrolled diabetes, human immunodeficiency virus (HIV) disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease
- Myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of study
- Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine
- Imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others. Exclude any prospective participant reporting suicidal ideation with intent, with or without a plan in the past 2 months or suicidal behavior in the past 6 months
- 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 hypersensitivity to more than two chemical classes of drugs, including prescription and over-the-counter medications
- Recent history (within the past 1 year) or current evidence of drug or alcohol abuse or "recreational use" of illicit drugs or prescription medications
- Donated blood products or has had phlebotomy of >300 ml within 8 weeks of study, or intends to donate blood products or receive blood products within 30 days before study and throughout study
- Consumption of 3 or more alcoholic drinks per day
- Body Mass Index >40 kg/m^2
- History of transmeridian travel (across >3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across >3 time zones) at any time during the study.
About this study
Official title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Patients With Episodic Migraine
The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2 weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the initial randomization. In the Run-out Period, participants who received placebo in the Treatment Period continued to receive placebo and participants who received MK-6096 in the Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as measured by the mean change from baseline in monthly migraine days averaged over the 12- week treatment period.
- Being tested
- MK-6096, Placebo
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6096Drug
MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily
PlaceboDrug
Placebo, 2 tablets, orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| MK-6096 | Experimental | Participants were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period were randomized 1:1 to receive double-blind MK-6096 or placebo once daily in the 2-week Run-out Period. Receives: Drug: MK-6096; Drug: Placebo |
| Placebo | Placebo comparator | Participants were randomized to receive double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period continued to receive double-blind placebo once daily in the 2-week Run-out Period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Monthly Migraine Days
Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.
Measured: Baseline and average over Treatment Period (Weeks 0-12)
Percentage of Participants With One or More Adverse Events
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.
Measured: Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14
Percentage of Participants Discontinued From Study Medication Due to an Adverse Event
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.
Measured: Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14
Secondary outcomes (3)
Mean Change From Baseline in Monthly Headache Days
Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days.
Measured: Baseline and average over Treatment Period (Weeks 0-12)
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days
Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model.
Measured: Baseline and average over Treatment Period (Weeks 0-12)
Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days
Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model.
Measured: Baseline and average over Treatment Period (Weeks 0-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study start6 Feb 2012
- Primary completion3 Oct 2012
- Study completion3 Oct 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 (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513291
- Sponsor's protocol ID
- 6096-020
- Status last verified
- Oct 2018
- First submitted
- 16 Jan 2012
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Chabi A, Zhang Y, Jackson S, Cady R, Lines C, Herring WJ, Connor KM, Michelson D. Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis. Cephalalgia. 2015 Apr;35(5):379-88. doi: 10.1177/0333102414544979. Epub 2014 Aug 8.
PubMed 25106663
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Patients With Episodic Migraine
- ClinicalTrials.gov ID
- NCT01513291
- Acronym / sponsor ID
- 6096-020
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2012 (actual)
- Primary completion
- 3 Oct 2012 (actual)
- Study completion
- 3 Oct 2012 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 20 Jul 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 evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2 weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the initial randomization. In the Run-out Period, participants who received placebo in the Treatment Period continued to receive placebo and participants who received MK-6096 in the Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as measured by the mean change from baseline in monthly migraine days averaged over the 12- week treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-6096 | Experimental | Drug: MK-6096, Drug: PlaceboParticipants were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period were randomized 1:1 to receive double-blind MK-6096 or placebo once daily in the 2-week Run-out Period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants were randomized to receive double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period continued to receive double-blind placebo once daily in the 2-week Run-out Period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- History of migraine with or without aura for >1 year and with ≥4 and ≤14 migraine days per month in the 3 months prior to study
- Male, female not of reproductive potential, or female of reproductive potential who is not pregnant by pregnancy test and agrees to use acceptable contraception
Key exclusion criteria (18 listed)
- Pregnancy, breast-feeding, or expecting to become pregnant
- Planning to donate egg or sperm during the study or within 90 days after last dose of study medication
- Basilar or hemiplegic migraine headache
- >50 years old at the age of migraine onset
- ≥15 headache-days per month or medication taken for acute migraine or other headaches on more than 10 days per month in any of the three months prior to study
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-6096MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily | Drug | MK-6096 |
| PlaceboPlacebo, 2 tablets, orally, once daily | Drug | MK-6096, Placebo |
Primary outcome
Mean Change From Baseline in Monthly Migraine Days
Time frame: Baseline and average over Treatment Period (Weeks 0-12)
Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.
Percentage of Participants With One or More Adverse Events
Time frame: Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.
Percentage of Participants Discontinued From Study Medication Due to an Adverse Event
Time frame: Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.
3 secondary outcomes
Mean Change From Baseline in Monthly Headache Days
Time frame: Baseline and average over Treatment Period (Weeks 0-12)
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days
Time frame: Baseline and average over Treatment Period (Weeks 0-12)
Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days
Time frame: Baseline and average over Treatment Period (Weeks 0-12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25106663Chabi A, Zhang Y, Jackson S, Cady R, Lines C, Herring WJ, Connor KM, Michelson D. Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis. Cephalalgia. 2015 Apr;35(5):379-88. doi: 10.1177/0333102414544979. Epub 2014 Aug 8.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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
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)
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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-6096 in people with Migraine and Headache, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 18 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 7 Nov 2018. 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 20 Jul 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?
Mean Change From Baseline in Monthly Migraine Days (time frame: Baseline and average over Treatment Period (Weeks 0-12)). 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 NCT01513291, which also lists 1 linked publication.
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 7 Nov 2018.