MigrainePhase 3NCT00443209

Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

A Phase 3 study testing Telcagepant 300 mg soft gel capsules, Telcagepant 280 mg tablets and Rizatriptan 10 mg tablets 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 this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants. 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 300 mg soft gel capsules, Telcagepant 280 mg tablets and Rizatriptan 10 mg tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,068 participants
Where: No sites listed yet
Study dates: 21 Feb 2007to 22 Jan 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

At least 1 year history of migraine (with or without aura)
Females of child bearing potential must use acceptable contraception throughout trial
In general good health based on screening assessment

Who cannot join

Pregnant/breast-feeding (or is a female expecting to conceive during study period)
History or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
History of cancer within the last 5 years

About this study

Official title: A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura

Conditions: Migraine
Being tested: Telcagepant 300 mg soft gel capsules, Telcagepant 280 mg tablets, Rizatriptan 10 mg tablets, Placebo to telcagepant capsules, Placebo to telcagepant tablets
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 300 mg soft gel capsulesDrug
One capsule taken orally at onset of migraine
Telcagepant 280 mg tabletsDrug
One tablet taken orally at onset of migraine
Rizatriptan 10 mg tabletsDrug
One tablet taken orally at onset of migraine
Placebo to telcagepant capsulesDrug
One capsule taken orally at onset of migraine
Placebo to telcagepant tabletsDrug
One tablet taken orally at onset of migraine
Placebo to rizatriptan tabletsDrug
One tablet taken orally at onset of migraine

Study groups in NCT00443209
Study group	Role	What they receive
Telcagepant 280 mg/300 mg	Experimental	Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. Receives: Drug: Telcagepant 300 mg soft gel capsules; Drug: Telcagepant 280 mg tablets; Drug: Placebo to rizatriptan tablets
Rizatriptan 10 mg	Active comparator	Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months. Receives: Drug: Rizatriptan 10 mg tablets; Drug: Placebo to telcagepant capsules; Drug: Placebo to telcagepant tablets

What is being measured

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

Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.
Measured: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participants With At Least One Clinical AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study 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 is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.
Measured: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participants With At Least One Laboratory AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study 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 is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.
Measured: Within 14 days of any dose of study drug (Up to 18.5 months)
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.
Measured: Within 14 days of any dose of study drug (Up to 18.5 months)

Secondary outcomes (1)

Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.
Measured: 2 hours post-dose (Up to 18 months)

Timeline

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

21 Feb 200722 Jan 2009

First posted5 Mar 2007 (estimated)
Study start21 Feb 2007
Primary completion22 Jan 2009
Study completion22 Jan 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,068 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00443209
Sponsor's protocol ID: 0974-012
Other IDs: MK-0974-012, 2006_524
Status last verified: Sep 2018
First submitted: 28 Feb 2007
Last updated: 17 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

Connor KM, Aurora SK, Loeys T, Ashina M, Jones C, Giezek H, Massaad R, Williams-Diaz A, Lines C, Ho TW. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial. Headache. 2011 Jan;51(1):73-84. doi: 10.1111/j.1526-4610.2010.01799.x. Epub 2010 Nov 10.
PubMed 21070230

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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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura
ClinicalTrials.gov ID: NCT00443209
Acronym / sponsor ID: 0974-012
Conditions: Migraine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,068 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Feb 2007 (actual)
Primary completion: 22 Jan 2009 (actual)
Study completion: 22 Jan 2009 (actual)
First posted: 5 Mar 2007 (estimated)
Results: Posted 18 Aug 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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Telcagepant 280 mg/300 mg	Experimental	Drug: Telcagepant 300 mg soft gel capsules, Drug: Telcagepant 280 mg tablets, Drug: Placebo to rizatriptan tabletsParticipants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
Rizatriptan 10 mg	Active comparator	Drug: Rizatriptan 10 mg tablets, Drug: Placebo to telcagepant capsules, Drug: Placebo to telcagepant tabletsParticipants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.

Who may qualify

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

Key inclusion criteria (3 listed)

At least 1 year history of migraine (with or without aura)
Females of child bearing potential must use acceptable contraception throughout trial
In general good health based on screening assessment

Key exclusion criteria (5 listed)

Pregnant/breast-feeding (or is a female expecting to conceive during study period)
History or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
History of cancer within the last 5 years

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 300 mg soft gel capsulesOne capsule taken orally at onset of migraine	Drug	Telcagepant 280 mg/300 mg
Telcagepant 280 mg tabletsOne tablet taken orally at onset of migraine	Drug	Telcagepant 280 mg/300 mg
Rizatriptan 10 mg tabletsOne tablet taken orally at onset of migraine	Drug	Rizatriptan 10 mg
Placebo to telcagepant capsulesOne capsule taken orally at onset of migraine	Drug	Rizatriptan 10 mg
Placebo to telcagepant tabletsOne tablet taken orally at onset of migraine	Drug	Rizatriptan 10 mg
Placebo to rizatriptan tabletsOne tablet taken orally at onset of migraine	Drug	Telcagepant 280 mg/300 mg

Primary outcome

Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.
Percentage of Participants With At Least One Clinical AE
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study 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 is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.
Percentage of Participants With At Least One Laboratory AE
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study 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 is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Time frame: Within 14 days of any dose of study drug (Up to 18.5 months)
Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.

1 secondary outcome

Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
Time frame: 2 hours post-dose (Up to 18 months)

Results and safety

Results posted to the registry on 18 Aug 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 280 mg/300 mg	712	367
Rizatriptan 10 mg	356	202

Primary outcome: Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)

Time frame: Within 14 days of any dose of study drug (Up to 18.5 months). Number. Unit: Percentage of Participants

Measure	Telcagepant 280 mg/300 mg n = 641	Rizatriptan 10 mg n = 313
Value	5.0	11.2

Telcagepant 280 mg/300 mg vs Rizatriptan 10 mg: Treatment Difference: -6.2 (95% CI -10.4 to -2.6), p <0.001, Miettenen and Nurminen method

Population analysed: The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With At Least One Clinical AE

Time frame: Within 14 days of any dose of study drug (Up to 18.5 months). Number. Unit: Percentage of Participants

Measure	Telcagepant 280 mg/300 mg n = 641	Rizatriptan 10 mg n = 313
Value	58.7	63.9

Telcagepant 280 mg/300 mg vs Rizatriptan 10 mg: Treatment Difference: -5.2 (95% CI -11.7 to 1.4)

Population analysed: The APAT population consisted of all participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With At Least One Laboratory AE

Time frame: Within 14 days of any dose of study drug (Up to 18.5 months). Number. Unit: Percentage of Participants

Measure	Telcagepant 280 mg/300 mg n = 641	Rizatriptan 10 mg n = 313
Value	1.9	1.6

Telcagepant 280 mg/300 mg vs Rizatriptan 10 mg: Treatment Difference: 0.3 (95% CI -2.0 to 2.0)

Population analysed: The APAT population consisted of all participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change

Time frame: Within 14 days of any dose of study drug (Up to 18.5 months). Number. Unit: Percentage of Participants

Measure	Telcagepant 280 mg/300 mg n = 641	Rizatriptan 10 mg n = 313
Systolic Blood Pressure Increase	0.2	0.3
Systolic Blood Pressure Decrease	1.4	1.3
Diastolic Blood Pressure Increase	0.3	0.6
Diastolic Blood Pressure Decrease	1.1	1.0
Pulse Increase	0.0	0.0
Pulse Decrease	0.6	1.6
Body Temperature Increase	0.3	0.3
Respiratory Rate Increase or Decrease	0.8	0.6

Population analysed: The APAT population consisted of all participants who received at least one dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 14 days after any dose of study drug (Up to 18.5 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telcagepant 280 mg/300 mg	12 of 641 (1.9%)	187 of 641 (29.2%)	Not reported
Rizatriptan 10 mg	6 of 313 (1.9%)	127 of 313 (40.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21070230Connor KM, Aurora SK, Loeys T, Ashina M, Jones C, Giezek H, Massaad R, Williams-Diaz A, Lines C, Ho TW. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial. Headache. 2011 Jan;51(1):73-84. doi: 10.1111/j.1526-4610.2010.01799.x. Epub 2010 Nov 10.
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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telcagepant 300 mg soft gel capsules, Telcagepant 280 mg tablets and Rizatriptan 10 mg tablets 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 5 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 17 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 18 Aug 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 At Least One Triptan-Related Adverse Experience (AE) (time frame: Within 14 days of any dose of study drug (Up to 18.5 months)). 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 NCT00443209, 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 17 Oct 2018.