Migraine DisordersPhase 3NCT00662818

Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

A Phase 3 study testing Telcagepant and Acetaminophen/Paracetamol in people with Migraine Disorders and Heart Disease, 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 this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine Disorders, Heart Disease, Cerebrovascular Accident
What is being tested?: Telcagepant and Acetaminophen/Paracetamol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: No sites listed yet
Study dates: 17 Mar 2008to 2 Sep 2009
Phase: Phase 3
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

Stable coronary artery disease for 3 months or more
18 years of age or older with a history of migraine with or without aura
Must use acceptable contraception throughout the study

Who cannot join

Pregnant, breast-feeding, or planning to become pregnant during this study
50 years of age or older when migraines began
Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease

Conditions: Migraine Disorders, Heart Disease, Cerebrovascular Accident, TIA (Transient Ischemic Attack), Vascular Diseases, Peripheral Vascular Diseases
Being tested: Telcagepant, Acetaminophen/Paracetamol, Placebo to Telcagepant, Placebo to Acetaminophen/Paracetamol
Medical subject headings: Migraine Disorders, Heart Diseases, Stroke, Ischemic Attack, Transient, Vascular Diseases, Peripheral Vascular Diseases

What participants receive

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

TelcagepantDrug
Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
Acetaminophen/ParacetamolDrug
Acetaminophen/Paracetamol (500 mg X 2 dosage units)
Placebo to TelcagepantDrug
Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
Placebo to Acetaminophen/ParacetamolDrug
Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Study groups in NCT00662818
Study group	Role	What they receive
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg	Experimental	Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned. Receives: Drug: Telcagepant; Drug: Acetaminophen/Paracetamol; Drug: Placebo to Telcagepant; Drug: Placebo to Acetaminophen/Paracetamol
Placebo and APAP 1000 mg→Telcagepant 300 mg	Experimental	Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned. Receives: Drug: Telcagepant; Drug: Acetaminophen/Paracetamol; Drug: Placebo to Telcagepant; Drug: Placebo to Acetaminophen/Paracetamol

What is being measured

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

Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Measured: 2 hours post-dose (Up to 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Within 14 days of any dose of study medication (Up to 16 weeks)
Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 48 hours post-dose (Up to 14 weeks)

Secondary outcomes (6)

Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Measured: 2 hours post-dose (Up to 6 weeks)
Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.
Measured: Up to 48 hours after the dose of any study medication (Up to 14 weeks)
Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Measured: 2 hours post-dose (Up to 6 weeks)
Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Measured: 2 Hours post-dose (Up to 6 weeks)
Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
The participant recorded whether nausea was present or absent at each of the predefined time points.
Measured: 2 hours post-dose (Up to 6 weeks)
Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.
Measured: Up to 24 hours post-dose (Up to 14 weeks)

Timeline

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

17 Mar 20082 Sep 2009

First posted21 Apr 2008 (estimated)
Study start17 Mar 2008
Primary completion2 Sep 2009
Study completion2 Sep 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 Migraine DisordersStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00662818
Sponsor's protocol ID: 0974-034
Other IDs: MK-0974-034, 2007_545
Status last verified: Sep 2018
First submitted: 17 Apr 2008
Last updated: 19 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, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6.
PubMed 22221076

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 Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease
ClinicalTrials.gov ID: NCT00662818
Acronym / sponsor ID: 0974-034
Conditions: Migraine Disorders, Heart Disease, Cerebrovascular Accident, TIA (Transient Ischemic Attack), Vascular Diseases, Peripheral Vascular Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 Mar 2008 (actual)
Primary completion: 2 Sep 2009 (actual)
Study completion: 2 Sep 2009 (actual)
First posted: 21 Apr 2008 (estimated)
Results: Posted 17 Sep 2014

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg	Experimental	Drug: Telcagepant, Drug: Acetaminophen/Paracetamol, Drug: Placebo to Telcagepant, Drug: Placebo to Acetaminophen/ParacetamolParticipants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Placebo and APAP 1000 mg→Telcagepant 300 mg	Experimental	Drug: Telcagepant, Drug: Acetaminophen/Paracetamol, Drug: Placebo to Telcagepant, Drug: Placebo to Acetaminophen/ParacetamolParticipants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.

Who may qualify

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

Key inclusion criteria (3 listed)

Stable coronary artery disease for 3 months or more
18 years of age or older with a history of migraine with or without aura
Must use acceptable contraception throughout the study

Key exclusion criteria (4 listed)

Pregnant, breast-feeding, or planning to become pregnant during this study
50 years of age or older when migraines began
Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

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
TelcagepantTelcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)	Drug	Placebo and APAP 1000 mg→Telcagepant 300 mg, Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
Acetaminophen/ParacetamolAcetaminophen/Paracetamol (500 mg X 2 dosage units)	Drug	Placebo and APAP 1000 mg→Telcagepant 300 mg, Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
Placebo to TelcagepantPlacebo 300 mg soft gel capsules or placebo 280 mg tablet.	Drug	Placebo and APAP 1000 mg→Telcagepant 300 mg, Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
Placebo to Acetaminophen/ParacetamolPlacebo to acetaminophen/paracetamol (500 mg X 2 dosage units)	Drug	Placebo and APAP 1000 mg→Telcagepant 300 mg, Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

Primary outcome

Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Time frame: 2 hours post-dose (Up to 6 weeks)
Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
Time frame: Within 14 days of any dose of study medication (Up to 16 weeks)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
Time frame: Up to 48 hours post-dose (Up to 14 weeks)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

6 secondary outcomes

Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Time frame: 2 hours post-dose (Up to 6 weeks)
Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
Time frame: Up to 48 hours after the dose of any study medication (Up to 14 weeks)
Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Time frame: 2 hours post-dose (Up to 6 weeks)
Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Time frame: 2 Hours post-dose (Up to 6 weeks)
Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
Time frame: 2 hours post-dose (Up to 6 weeks)
Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
Time frame: Up to 24 hours post-dose (Up to 14 weeks)

Results and safety

Results posted to the registry on 17 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 300 mg→Acetaminophen/Paracetamol 1000 mg	84	56
Placebo and APAP 1000 mg→Telcagepant 300 mg	81	58

Primary outcome: Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)

Time frame: 2 hours post-dose (Up to 6 weeks). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Telcagepant 300 mg n = 52	Placebo n = 53
Value	25.0 (14.0 to 38.9)	18.9 (9.4 to 32.0)

Telcagepant 300 mg vs Placebo: Odds Ratio (OR): 1.62 (95% CI 0.62 to 4.25), p = 0.329, Regression, Logistic

Population analysed: The full-analysis set (FAS) included participants treated for a migraine attack. Participants had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.

Primary outcome: Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose

Time frame: Within 14 days of any dose of study medication (Up to 16 weeks). Number. Unit: Participants

Measure	Telcagepant 300 mg n = 98	Acetaminophen/Paracetamol (APAP) n = 86
Value	21	14

Population analysed: All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.

Primary outcome: Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose

Time frame: Up to 48 hours post-dose (Up to 14 weeks). Number. Unit: Participants

Measure	Telcagepant 300 mg n = 98	APAP n = 86
Value	0	0

Population analysed: The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 48 hours post-dose (Up to 14 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telcagepant	1 of 98 (1%)	0 of 98 (0%)	Not reported
Acetaminophen/Paracetamol	0 of 86 (0%)	0 of 86 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22221076Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6.
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.

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 3 study testing Telcagepant and Acetaminophen/Paracetamol in people with Migraine Disorders and Heart Disease, 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 4 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 19 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 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?

Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1) (time frame: 2 hours post-dose (Up to 6 weeks)). 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 NCT00662818, 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 19 Oct 2018.