MigrainesPhase 3NCT00483704

Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

A Phase 3 study testing Telcagepant 140 mg and Talcagepant 280 mg in people with Migraines, 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 assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraines
What is being tested?: Telcagepant 140 mg and Talcagepant 280 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,935 participants
Where: No sites listed yet
Study dates: 14 Aug 2008to 25 Mar 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

History of migraines within the past year
1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
Use acceptable contraception throughout the study
Able to complete the study questionnaire(s) and paper diary
Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Who cannot join

Pregnant or breast-feeding or is expecting to become pregnant during the study
Difficulty distinguishing his/her migraine attacks from tension or interval headaches
A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
Greater than 50 years old at the age of migraine onset
Previously taken telcagepant

About this study

Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura

Conditions: Migraines
Being tested: Telcagepant 140 mg, Talcagepant 280 mg, Placebo
Keywords: multiple attacks of moderate to severe migraine headaches
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
Telcagepant 140 mg tablets
Talcagepant 280 mgDrug
Telcagepant 280 mg tablets
PlaceboDrug
Placebo tablets

Study groups in NCT00483704
Study group	Role	What they receive
Telcagepant 140 mg	Experimental	Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. Receives: Drug: Telcagepant 140 mg
Telcagepant 280 mg	Experimental	Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. Receives: Drug: Talcagepant 280 mg
Control Group 1	Placebo comparator	Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. Receives: Drug: Telcagepant 140 mg; Drug: Placebo
Control Group 2	Placebo comparator	Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. Receives: Drug: Telcagepant 140 mg; Drug: Placebo

What is being measured

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

Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 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 for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
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 for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.
Measured: 2 hours post-dose (up to 6 months)
Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.
Measured: 2 hours post-dose (up to 6 months)
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Measured: 2 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Measured: 2 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
The participant recorded whether nausea was present or absent at each of the predefined time points.
Measured: 2 hours post-dose for the first migraine attack (up to 6 months)
Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.
Measured: Up to 48 hours post-dose for the first migraine attack (up to 6 months)
Number of Participants Discontinuing Study Medication Due to an AE
Participants discontinuing study medication due to an AE were reported for all migraine attacks.
Measured: Up to the 4th dose of study medication (up to 6 months)

Secondary outcomes (4)

Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. 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: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 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 48 hours after dosing with the study medication.
Measured: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.
Measured: 2 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.
Measured: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)

Timeline

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

14 Aug 200825 Mar 2009

First posted7 Jun 2007 (estimated)
Study start14 Aug 2008
Primary completion25 Mar 2009
Study completion25 Mar 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 MigrainesStudies 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: 1,935 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00483704
Sponsor's protocol ID: 0974-031
Other IDs: MK-0974-031, 2007_546
Status last verified: Sep 2018
First submitted: 15 May 2007
Last updated: 18 Oct 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

Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.
PubMed 20974601

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 Migraines 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 Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura
ClinicalTrials.gov ID: NCT00483704
Acronym / sponsor ID: 0974-031
Conditions: Migraines
Keywords: multiple attacks of moderate to severe migraine headaches
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,935 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 14 Aug 2008 (actual)
Primary completion: 25 Mar 2009 (actual)
Study completion: 25 Mar 2009 (actual)
First posted: 7 Jun 2007 (estimated)
Results: Posted 29 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: 4

Arm	Type	Receives
Telcagepant 140 mg	Experimental	Drug: Telcagepant 140 mgTelcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
Telcagepant 280 mg	Experimental	Drug: Talcagepant 280 mgTelcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
Control Group 1	Placebo comparator	Drug: Telcagepant 140 mg, Drug: PlaceboPlacebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Control Group 2	Placebo comparator	Drug: Telcagepant 140 mg, Drug: PlaceboPlacebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.

Who may qualify

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

Key inclusion criteria (5 listed)

History of migraines within the past year
1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
Use acceptable contraception throughout the study
Able to complete the study questionnaire(s) and paper diary
Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Key exclusion criteria (6 listed)

Pregnant or breast-feeding or is expecting to become pregnant during the study
Difficulty distinguishing his/her migraine attacks from tension or interval headaches
A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
Greater than 50 years old at the age of migraine onset

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 mgTelcagepant 140 mg tablets	Drug	Control Group 1, Control Group 2, Telcagepant 140 mg
Talcagepant 280 mgTelcagepant 280 mg tablets	Drug	Telcagepant 280 mg
PlaceboPlacebo tablets	Drug	Control Group 1, Control Group 2

Primary outcome

Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 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.
Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
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.
Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
Time frame: 2 hours post-dose (up to 6 months)
Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.
Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
Time frame: 2 hours post-dose (up to 6 months)
Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
The participant recorded whether nausea was present or absent at each of the predefined time points.
Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
Time frame: Up to 48 hours post-dose for the first migraine attack (up to 6 months)
AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.
Number of Participants Discontinuing Study Medication Due to an AE
Time frame: Up to the 4th dose of study medication (up to 6 months)
Participants discontinuing study medication due to an AE were reported for all migraine attacks.

4 secondary outcomes

Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Time frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
Time frame: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Time frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)

Results and safety

Results posted to the registry on 29 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 140 mg	644	573
Telcagepant 280 mg	645	549
Placebo	646	555

Primary outcome: Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)

Time frame: 2 hours post-dose for the first migraine attack (up to 6 months). Number. Unit: Percentage of participants

Measure	Telcagepant 140 mg n = 556	Telcagepant 280 mg n = 534	Placebo n = 539
Value	21.9	25.1	10.2

Telcagepant 140 mg vs Placebo: Odds Ratio (OR): 2.54 (95% CI 1.80 to 3.58), p <0.001, Regression, Logistic
Telcagepant 280 mg vs Placebo: Odds Ratio (OR): 3.03 (95% CI 2.15 to 4.27), p <0.001, Regression, Logistic

Population analysed: The full-analysis set (FAS) included participants treated that migraine attack, and 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: Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)

Time frame: 2 hours post-dose for the first migraine attack (up to 6 months). Number. Unit: Percentage of participants

Measure	Telcagepant 140 mg n = 556	Telcagepant 280 mg n = 534	Placebo n = 539
Value	58.6	56.7	33.4

Telcagepant 140 mg vs Placebo: Odds Ratio (OR): 3.03 (95% CI 2.35 to 3.90), p <0.001, Regression, Logistic
Telcagepant 280 mg vs Placebo: Odds Ratio (OR): 2.80 (95% CI 2.17 to 3.61), p <0.001, Regression, Logistic

Population analysed: The FAS Population included participants treated that migraine attack, and 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: Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose

Time frame: 2 hours post-dose (up to 6 months). Number. Unit: Percentage of participants

Measure	Telcagepant 140 mg n = 493	Telcagepant 280 mg n = 468	Placebo n = 485
Value	9.3	14.1	2.7

Telcagepant 140 mg vs Placebo: Odds Ratio (OR): 3.85 (95% CI 2.05 to 7.23), p <0.001, Regression, Logistic
Telcagepant 280 mg vs Placebo: Odds Ratio (OR): 6.18 (95% CI 3.36 to 11.39), p <0.001, Regression, Logistic

Population analysed: The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.

Primary outcome: Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose

Time frame: 2 hours post-dose (up to 6 months). Number. Unit: Percentage of participants

Measure	Telcagepant 140 mg n = 469	Telcagepant 280 mg n = 440	Placebo n = 452
Value	41.8	46.8	22.3

Telcagepant 140 mg vs Placebo: Odds Ratio (OR): 2.62 (95% CI 1.96 to 3.51), p <0.001, Regression, Logistic
Telcagepant 280 mg vs Placebo: Odds Ratio (OR): 3.23 (95% CI 2.41 to 4.34), p <0.001, Regression, Logistic

Population analysed: The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days post-dose (up to 6 1/2 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telcagepant 140 mg	8 of 573 (1.4%)	166 of 573 (29%)	Not reported
Telcagepant 280 mg	8 of 543 (1.5%)	144 of 543 (26.5%)	Not reported
Placebo	4 of 561 (0.7%)	138 of 561 (24.6%)	Not reported

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.
Derived from this study: PubMed 20974601Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 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 3 study testing Telcagepant 140 mg and Talcagepant 280 mg in people with Migraines, 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 5 inclusion and 6 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 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 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 29 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 Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) (time frame: 2 hours post-dose for the first migraine attack (up to 6 months)). The study lists 9 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 NCT00483704, 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.