MigrainePhase 2NCT00712725

MK3207 for Treatment of Acute Migraines (3207-005)

A Phase 2 study testing MK3207- 2.5 mg, MK3207- 5 mg and MK3207- 10 mg in people with Migraine, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 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?: MK3207- 2.5 mg, MK3207- 5 mg and MK3207- 10 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 676 participants
Where: No sites listed yet
Study dates: Jul 2008to Jan 2009
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

Men and Women from 18 to 65 years of age
1+ year history of migraine that typically last from 4 to 72 hours if untreated
Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
Not pregnant or planning to become pregnant in next 6 months

Who cannot join

Pregnant or breast-feeding, or planning to become pregnant in next 6 months
Cannot distinguish migraine attacks from tension type headaches
Migraines are mild or resolve without medication in less than 2 hours
More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
Basilar type or hemiplegic migraine headaches
More than 50 years old when migraines began
History of cardiovascular disorder within last 6 months

About this study

Official title: A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine

The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.

Conditions: Migraine
Being tested: MK3207- 2.5 mg, MK3207- 5 mg, MK3207- 10 mg, MK3207- 20 mg, MK3207- 50 mg
Medical subject headings: Migraine Disorders

What participants receive

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

MK3207- 2.5 mgDrug
Also called MK3207
Arm 1: MK3207 2.5 mg taken after migraine onset.
MK3207- 5 mgDrug
Also called MK3207
Arm 2: MK3207 5 mg taken after migraine onset.
MK3207- 10 mgDrug
Also called MK3207
Arm 3: MK3207 10 mg taken after migraine onset.
MK3207- 20 mgDrug
Also called MK3207
Arm 4: MK3207 20 mg taken after migraine onset.
MK3207- 50 mgDrug
Also called MK3207
Arm 5: MK3207 50 mg taken after migraine onset.
MK3207- 100 mgDrug
Also called MK3207
Arm 6: MK3207 100 mg taken after migraine onset.
Comparator: placebo (unspecified)Drug
Placebo taken after migraine onset.

Study groups in NCT00712725
Study group	Role	What they receive
1	Experimental	MK3207- 2.5 mg Receives: Drug: MK3207- 2.5 mg
2	Experimental	MK3207- 5 mg Receives: Drug: MK3207- 5 mg
3	Experimental	MK3207- 10 mg Receives: Drug: MK3207- 10 mg
4	Experimental	MK3207- 20 mg Receives: Drug: MK3207- 20 mg
5	Experimental	MK3207- 50 mg Receives: Drug: MK3207- 50 mg
6	Experimental	MK3207- 100 mg Receives: Drug: MK3207- 100 mg
7	Placebo comparator	Placebo Receives: Drug: Comparator: placebo (unspecified)

What is being measured

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

Pain Freedom (PF)
Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.
Rating of Headache Severity (Scale from Grade 0 to 3):
- Grade 0: No pain
- Grade 1: Mild pain
- Grade 2: Moderate pain
- Grade 3: Severe pain
Measured: 2 hours postdose

Secondary outcomes (5)

Pain Relief (PR)
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.
Rating of Headache Severity (Scale from Grade 0 to 3):
- Grade 0: No pain
- Grade 1: Mild pain
- Grade 2: Moderate pain
- Grade 3: Severe pain
Measured: 2 hours postdose
Absence of Photophobia
Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
Measured: 2 hours postdose
Absence of Phonophobia
Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
Measured: 2 hours postdose
Absence of Nausea
Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
Measured: 2 hours postdose
Sustained Pain Freedom (SPF)
Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.
Measured: 2-24 hours postdose

Timeline

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

Jul 2008Jan 2009

First posted10 Jul 2008 (estimated)
Study startJul 2008
Primary completionJan 2009
Study completionJan 2009

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 676 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00712725
Sponsor's protocol ID: 3207-005
Other IDs: 2008_536
Status last verified: Jan 2015
First submitted: 8 Jul 2008
Last updated: 2 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.
PubMed 21383045

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
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Recruiting
Marine Lipids Ease Painful TMD
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2015. 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 MK3207 in the Treatment of Acute Migraine
ClinicalTrials.gov ID: NCT00712725
Acronym / sponsor ID: 3207-005
Conditions: Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 676 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 10 Jul 2008 (estimated)
Results: Posted 22 Nov 2010

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 the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 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: 7

Arm	Type	Receives
1	Experimental	Drug: MK3207- 2.5 mgMK3207- 2.5 mg
2	Experimental	Drug: MK3207- 5 mgMK3207- 5 mg
3	Experimental	Drug: MK3207- 10 mgMK3207- 10 mg
4	Experimental	Drug: MK3207- 20 mgMK3207- 20 mg
5	Experimental	Drug: MK3207- 50 mgMK3207- 50 mg
6	Experimental	Drug: MK3207- 100 mgMK3207- 100 mg
7	Placebo comparator	Drug: Comparator: placebo (unspecified)Placebo

Who may qualify

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

Key inclusion criteria (4 listed)

Men and Women from 18 to 65 years of age
1+ year history of migraine that typically last from 4 to 72 hours if untreated
Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
Not pregnant or planning to become pregnant in next 6 months

Key exclusion criteria (7 listed)

Pregnant or breast-feeding, or planning to become pregnant in next 6 months
Cannot distinguish migraine attacks from tension type headaches
Migraines are mild or resolve without medication in less than 2 hours
More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
Basilar type or hemiplegic migraine headaches

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
MK3207- 2.5 mgAlso: MK3207Arm 1: MK3207 2.5 mg taken after migraine onset.	Drug	1
MK3207- 5 mgAlso: MK3207Arm 2: MK3207 5 mg taken after migraine onset.	Drug	2
MK3207- 10 mgAlso: MK3207Arm 3: MK3207 10 mg taken after migraine onset.	Drug	3
MK3207- 20 mgAlso: MK3207Arm 4: MK3207 20 mg taken after migraine onset.	Drug	4
MK3207- 50 mgAlso: MK3207Arm 5: MK3207 50 mg taken after migraine onset.	Drug	5
MK3207- 100 mgAlso: MK3207Arm 6: MK3207 100 mg taken after migraine onset.	Drug	6
Comparator: placebo (unspecified)Placebo taken after migraine onset.	Drug	7

Primary outcome

Pain Freedom (PF)
Time frame: 2 hours postdose
Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain

5 secondary outcomes

Pain Relief (PR)
Time frame: 2 hours postdose
Absence of Photophobia
Time frame: 2 hours postdose
Absence of Phonophobia
Time frame: 2 hours postdose
Absence of Nausea
Time frame: 2 hours postdose
Sustained Pain Freedom (SPF)
Time frame: 2-24 hours postdose

Results and safety

Results posted to the registry on 22 Nov 2010, 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	169	140
MK3207 2.5 mg	39	33
MK3207 5 mg	57	47
MK3207 10 mg	84	67
MK3207 20 mg	86	67
MK3207 50 mg	84	68
MK3207 100 mg	83	61
MK3207 200 mg	74	63

Primary outcome: Pain Freedom (PF)

Time frame: 2 hours postdose. Number. Unit: Participants

Measure	Placebo n = 133	MK3207 2.5 mg n = 32	MK3207 5 mg n = 44	MK3207 10 mg n = 63	MK3207 20 mg n = 63	MK3207 50 mg n = 65	MK3207 100 mg n = 59	MK3207 200 mg n = 58
Value	13	4	5	16	12	14	14	21

Placebo vs MK3207 2.5 mg vs MK3207 5 mg vs MK3207 10 mg vs MK3207 20 mg vs MK3207 50 mg vs MK3207 100 mg vs MK3207 200 mg: p <0.001, Generalized linear regression model

Population analysed: Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 142 (0.7%)	20 of 142 (14.1%)	Not reported
MK3207 2.5 mg	0 of 32 (0%)	10 of 32 (31.3%)	Not reported
MK3207 5 mg	0 of 47 (0%)	18 of 47 (38.3%)	Not reported
MK3207 10 mg	1 of 66 (1.5%)	9 of 66 (13.6%)	Not reported
MK3207 20 mg	0 of 67 (0%)	14 of 67 (20.9%)	Not reported
MK3207 50 mg	0 of 68 (0%)	16 of 68 (23.5%)	Not reported
MK3207 100 mg	0 of 62 (0%)	17 of 62 (27.4%)	Not reported
MK3207 200 mg	0 of 63 (0%)	11 of 63 (17.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21383045Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
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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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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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK3207- 2.5 mg, MK3207- 5 mg and MK3207- 10 mg in people with Migraine, 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 4 inclusion and 7 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 2 Feb 2015. 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 22 Nov 2010). 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?

Pain Freedom (PF) (time frame: 2 hours postdose). 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 NCT00712725, 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 2 Feb 2015.