MigrainePhase 2NCT00797667

MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

A Phase 2 study testing Telcagepant 140 mg and Telcagepant 280 mg in people with Migraine, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: Telcagepant 140 mg and Telcagepant 280 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 660 participants
Where: No sites listed yet
Study dates: 12 Nov 2008to 20 May 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is 18 years of age or older
Patient has had a history of migraine with or without aura
Patient is able to complete study questionnaire(s) and paper diary

Who cannot join

Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
Patient was older than 50 years of age at migraine onset
History of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
Currently participating in a study with MK-0974 or MK-3207

About this study

Official title: A Phase IIa, Multicenter, Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine

A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.

Conditions: Migraine
Being tested: Telcagepant 140 mg, Telcagepant 280 mg, 140 mg telcagepant placebo, 280 mg telcagepant placebo
Medical subject headings: Migraine Disorders

What participants receive

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

Telcagepant 140 mgDrug
Also called MK-0974
Telcagepant 280 mgDrug
Also called MK-0974
140 mg telcagepant placeboDrug
280 mg telcagepant placeboDrug

Study groups in NCT00797667
Study group	Role	What they receive
Telcagepant 140 mg	Experimental	Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks Receives: Drug: Telcagepant 140 mg; Drug: 280 mg telcagepant placebo
Telcagepant 280 mg	Experimental	Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks Receives: Drug: Telcagepant 280 mg; Drug: 140 mg telcagepant placebo
Placebo	Placebo comparator	Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks Receives: Drug: 140 mg telcagepant placebo; Drug: 280 mg telcagepant placebo

What is being measured

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

Change From Baseline in Mean Monthly Headache Days
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.
Measured: Baseline and Week 12
Change From Baseline in Mean Monthly Migraine Days
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.
Measured: Baseline and Week 12
Percentage of Participants Who Experienced an Adverse Event
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.
Measured: up to 14 days after last dose of study drug (up to 12 weeks)
Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.
Measured: up to 12 weeks

Secondary outcomes (3)

Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized
Measured: Week 12
Change From Baseline in the Mean Monthly Migraine Attacks
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.
Measured: Baseline and Week 12
Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication
Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.
Measured: Baseline and Week 12

Timeline

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

12 Nov 200820 May 2009

First posted25 Nov 2008 (estimated)
Study start12 Nov 2008
Primary completion20 May 2009
Study completion20 May 2009

Why it stopped: The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases

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: 660 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797667
Sponsor's protocol ID: 0974-049
Other IDs: 2008_591
Status last verified: Sep 2018
First submitted: 24 Nov 2008
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X, Lines C, Edvinsson L, Goadsby PJ, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014 Sep 9;83(11):958-66. doi: 10.1212/WNL.0000000000000771. Epub 2014 Aug 8.
PubMed 25107879

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

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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 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 Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine
ClinicalTrials.gov ID: NCT00797667
Acronym / sponsor ID: 0974-049
Conditions: Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases
Enrolment: 660 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Nov 2008 (actual)
Primary completion: 20 May 2009 (actual)
Study completion: 20 May 2009 (actual)
First posted: 25 Nov 2008 (estimated)
Results: Posted 8 Sep 2014

Clinical summary

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

A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Telcagepant 140 mg	Experimental	Drug: Telcagepant 140 mg, Drug: 280 mg telcagepant placeboParticipants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Telcagepant 280 mg	Experimental	Drug: Telcagepant 280 mg, Drug: 140 mg telcagepant placeboParticipants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Placebo	Placebo comparator	Drug: 140 mg telcagepant placebo, Drug: 280 mg telcagepant placeboParticipants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks

Who may qualify

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

Key inclusion criteria (3 listed)

Patient is 18 years of age or older
Patient has had a history of migraine with or without aura
Patient is able to complete study questionnaire(s) and paper diary

Key exclusion criteria (7 listed)

Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
Patient was older than 50 years of age at migraine onset
History of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the 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
Telcagepant 140 mgAlso: MK-0974	Drug	Telcagepant 140 mg
Telcagepant 280 mgAlso: MK-0974	Drug	Telcagepant 280 mg
140 mg telcagepant placebo	Drug	Placebo, Telcagepant 280 mg
280 mg telcagepant placebo	Drug	Placebo, Telcagepant 140 mg

Primary outcome

Change From Baseline in Mean Monthly Headache Days
Time frame: Baseline and Week 12
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.
Change From Baseline in Mean Monthly Migraine Days
Time frame: Baseline and Week 12
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.
Percentage of Participants Who Experienced an Adverse Event
Time frame: up to 14 days after last dose of study drug (up to 12 weeks)
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.
Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event
Time frame: up to 12 weeks
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.

3 secondary outcomes

Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days
Time frame: Week 12
Change From Baseline in the Mean Monthly Migraine Attacks
Time frame: Baseline and Week 12
Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 8 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telcagepant 140 mg	265	5
Telcagepant 280 mg	264	5
Placebo	131	4

Primary outcome: Change From Baseline in Mean Monthly Headache Days

Time frame: Baseline and Week 12. Mean (95% Confidence Interval). Unit: Days per month

Measure	Telcagepant 140 mg n = 248	Telcagepant 280 mg n = 247	Placebo n = 125
Value	-3.4 (-3.9 to -2.8)	-3.6 (-4.1 to -3.1)	-2.4 (-3.2 to -1.7)

Population analysed: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

Primary outcome: Change From Baseline in Mean Monthly Migraine Days

Time frame: Baseline and Week 12. Mean (95% Confidence Interval). Unit: Days per month

Measure	Telcagepant 140 mg n = 248	Telcagepant 280 mg n = 247	Placebo n = 125
Value	-3.0 (-3.5 to -2.5)	-3.4 (-3.9 to -3.0)	-2.3 (-3.0 to -1.6)

Population analysed: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

Primary outcome: Percentage of Participants Who Experienced an Adverse Event

Time frame: up to 14 days after last dose of study drug (up to 12 weeks). Number. Unit: Percentage of Participants

Measure	Telcagepant 140 mg n = 263	Telcagepant 280 mg n = 265	Placebo n = 128
Value	52.5	54.0	57.8

Population analysed: All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.

Primary outcome: Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event

Time frame: up to 12 weeks. Number. Unit: Percentage of Participants

Measure	Telcagepant 140 mg n = 263	Telcagepant 280 mg n = 265	Placebo n = 128
Value	8.0	3.0	7.8

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 14 days after last dose of study drug (up to 12 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0974 140 mg	4 of 263 (1.5%)	61 of 263 (23.2%)	Not reported
MK-0974 280 mg	3 of 265 (1.1%)	73 of 265 (27.5%)	Not reported
Placebo	1 of 128 (0.8%)	30 of 128 (23.4%)	Not reported

Limitations and caveats (from the sponsor): Based on a recommendation from the external Data Safety Monitoring Board (DSMB), a decision to terminate the trial was made on 26-Mar-2009.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25107879Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X, Lines C, Edvinsson L, Goadsby PJ, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014 Sep 9;83(11):958-66. doi: 10.1212/WNL.0000000000000771. Epub 2014 Aug 8.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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 Telcagepant 140 mg and Telcagepant 280 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 3 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: stopped early, as of the sponsor's last update on 18 Oct 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 8 Sep 2014). 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?

Change From Baseline in Mean Monthly Headache Days (time frame: Baseline and Week 12). The study lists 4 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 NCT00797667, 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 18 Oct 2018.