MigrainePhase 3NCT00442936

Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

A Phase 3 study testing Telcagepant potassium 150 mg, Telcagepant potassium 300 mg and Zolmitriptan 5 mg in people with Migraine, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and… 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 potassium 150 mg, Telcagepant potassium 300 mg and Zolmitriptan 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,380 participants
Where: No sites listed yet
Study dates: 15 Feb 2007to 2 Oct 2007
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

Has at least 1 year history of migraine (with or without aura)
Females of child bearing potential must use acceptable contraception throughout trial.

Who cannot join

Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
Has 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
Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Has a history of cancer within the last 5 years.

About this study

Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura

The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.

Conditions: Migraine
Being tested: Telcagepant potassium 150 mg, Telcagepant potassium 300 mg, Zolmitriptan 5 mg, Placebo to telcagepant 150 mg, Placebo to tecagepant 300 mg
Medical subject headings: Migraine Disorders

What participants receive

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

Telcagepant potassium 150 mgDrug
Telcagepant 150 mg liquid-filled soft gel capsules
Telcagepant potassium 300 mgDrug
Telcagepant 300 mg liquid-filled soft gel capsules
Zolmitriptan 5 mgDrug
Zolmitriptan 5 mg tablets
Placebo to telcagepant 150 mgDrug
Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
Placebo to tecagepant 300 mgDrug
Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
Placebo to zolmitriptan 5 mgDrug
Placebo to match zolmitriptan 5 mg tablets
Rescue medicationDrug
If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Study groups in NCT00442936
Study group	Role	What they receive
Telcagepant 150 mg	Experimental	Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. Receives: Drug: Telcagepant potassium 150 mg; Drug: Placebo to tecagepant 300 mg; Drug: Placebo to zolmitriptan 5 mg; Drug: Rescue medication
Telcagepant 300 mg	Experimental	Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. Receives: Drug: Telcagepant potassium 300 mg; Drug: Placebo to telcagepant 150 mg; Drug: Placebo to zolmitriptan 5 mg; Drug: Rescue medication
Zolmitriptan 5 mg	Active comparator	Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. Receives: Drug: Zolmitriptan 5 mg; Drug: Placebo to telcagepant 150 mg; Drug: Placebo to tecagepant 300 mg; Drug: Rescue medication
Placebo	Placebo comparator	Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. Receives: Drug: Placebo to telcagepant 150 mg; Drug: Placebo to tecagepant 300 mg; Drug: Placebo to zolmitriptan 5 mg; Drug: Rescue medication

What is being measured

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

Number of Participants 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 a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.
Measured: 2 hours post-dose
Number of Participants With Pain Relief (PR) 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. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.
Measured: 2 hours post-dose
Number of Participants With Absence of Photophobia at 2 Hours Post-Dose
Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.
Measured: 2 hours post-dose
Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose
Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.
Measured: 2 hours post-dose
Number of Participants With Absence of Nausea at 2 Hours Post-Dose
Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.
Measured: 2 hours post-dose
Number of Participants Who Experience At Least One Adverse Event (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 drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.
Measured: Up to 14 days after last dose of study drug
Number of Participants Who Discontinue Study Drug Due to an 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 drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.
Measured: Up to 48 hours after first dose of study drug

Secondary outcomes (3)

Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose
SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.
Measured: 2 to 24 hours post-dose
Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose
TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.
Measured: 2 hours post-dose
Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose
TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.
Measured: 2 to 24 hours post-dose

Timeline

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

15 Feb 20072 Oct 2007

First posted5 Mar 2007 (estimated)
Study start15 Feb 2007
Primary completion2 Oct 2007
Study completion2 Oct 2007

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 (2)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: 1,380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442936
Sponsor's protocol ID: 0974-011
Other IDs: MK-0974-011, 2006_525
Status last verified: Sep 2018
First submitted: 28 Feb 2007
Last updated: 17 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 TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, Koppen H, Winner PK. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 Dec 20;372(9656):2115-23. doi: 10.1016/S0140-6736(08)61626-8. Epub 2008 Nov 25.
PubMed 19036425
Ho TW, Olesen J, Dodick DW, Kost J, Lines C, Ferrari MD. Antimigraine efficacy of telcagepant based on patient's historical triptan response. Headache. 2011 Jan;51(1):64-72. doi: 10.1111/j.1526-4610.2010.01790.x. Epub 2010 Nov 4.
PubMed 21054362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

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, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura
ClinicalTrials.gov ID: NCT00442936
Acronym / sponsor ID: 0974-011
Conditions: Migraine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,380 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 15 Feb 2007 (actual)
Primary completion: 2 Oct 2007 (actual)
Study completion: 2 Oct 2007 (actual)
First posted: 5 Mar 2007 (estimated)
Results: Posted 4 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 150 mg	Experimental	Drug: Telcagepant potassium 150 mg, Drug: Placebo to tecagepant 300 mg, Drug: Placebo to zolmitriptan 5 mg, Drug: Rescue medicationParticipants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg	Experimental	Drug: Telcagepant potassium 300 mg, Drug: Placebo to telcagepant 150 mg, Drug: Placebo to zolmitriptan 5 mg, Drug: Rescue medicationParticipants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg	Active comparator	Drug: Zolmitriptan 5 mg, Drug: Placebo to telcagepant 150 mg, Drug: Placebo to tecagepant 300 mg, Drug: Rescue medicationParticipants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo	Placebo comparator	Drug: Placebo to telcagepant 150 mg, Drug: Placebo to tecagepant 300 mg, Drug: Placebo to zolmitriptan 5 mg, Drug: Rescue medicationParticipants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

Who may qualify

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

Key inclusion criteria (2 listed)

Has at least 1 year history of migraine (with or without aura)
Females of child bearing potential must use acceptable contraception throughout trial.

Key exclusion criteria (5 listed)

Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
Has 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
Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Has a 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 potassium 150 mgTelcagepant 150 mg liquid-filled soft gel capsules	Drug	Telcagepant 150 mg
Telcagepant potassium 300 mgTelcagepant 300 mg liquid-filled soft gel capsules	Drug	Telcagepant 300 mg
Zolmitriptan 5 mgZolmitriptan 5 mg tablets	Drug	Zolmitriptan 5 mg
Placebo to telcagepant 150 mgPlacebo to match telcagepant 150 mg liquid-filled soft gel capsules	Drug	Placebo, Telcagepant 300 mg, Zolmitriptan 5 mg
Placebo to tecagepant 300 mgPlacebo to match tecagepant 300 mg liquid-filled soft gel capsules	Drug	Placebo, Telcagepant 150 mg, Zolmitriptan 5 mg
Placebo to zolmitriptan 5 mgPlacebo to match zolmitriptan 5 mg tablets	Drug	Placebo, Telcagepant 150 mg, Telcagepant 300 mg
Rescue medicationIf moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.	Drug	Placebo, Telcagepant 150 mg, Telcagepant 300 mg, Zolmitriptan 5 mg

Primary outcome

Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose
Time frame: 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 a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.
Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose
Time frame: 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. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.
Number of Participants With Absence of Photophobia at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.
Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.
Number of Participants With Absence of Nausea at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.
Number of Participants Who Experience At Least One Adverse Event (AE)
Time frame: Up to 14 days after last dose of study drug
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 drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to 48 hours after first dose of study drug
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 drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.

3 secondary outcomes

Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose
Time frame: 2 to 24 hours post-dose
Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose
Time frame: 2 to 24 hours post-dose

Results and safety

Results posted to the registry on 4 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 150 mg	333	332
Telcagepant 300 mg	354	354
Zolmitriptan 5 mg	345	344
Placebo	348	347

Primary outcome: Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number. Unit: Participants

Measure	Telcagepant 150 mg n = 317	Telcagepant 300 mg n = 338	Zolmitriptan 5 mg n = 328	Placebo n = 328
Value	56	89	101	29

Telcagepant 150 mg vs Placebo: Odds Ratio (OR): 2.26 (95% CI 1.40 to 3.66), p <0.001, Regression, Logistic
Telcagepant 300 mg vs Placebo: Odds Ratio (OR): 3.81 (95% CI 2.42 to 6.00), p <0.001, Regression, Logistic

Population analysed: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.

Primary outcome: Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number. Unit: Participants

Measure	Telcagepant 150 mg n = 317	Telcagepant 300 mg n = 338	Zolmitriptan 5 mg n = 328	Placebo n = 328
Value	157	183	185	88

Telcagepant 150 mg vs Placebo: Odds Ratio (OR): 2.82 (95% CI 2.02 to 3.95), p <0.001, Regression, Logistic
Telcagepant 300 mg vs Placebo: Odds Ratio (OR): 3.44 (95% CI 2.47 to 4.79), p <0.001, Regression, Logistic

Primary outcome: Number of Participants With Absence of Photophobia at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number. Unit: Participants

Measure	Telcagepant 150 mg n = 317	Telcagepant 300 mg n = 338	Zolmitriptan 5 mg n = 328	Placebo n = 327
Value	143	169	163	92

Telcagepant 150 mg vs Placebo: Odds Ratio (OR): 2.14 (95% CI 1.54 to 2.97), p <0.001, Regression, Logistic
Telcagepant 300 mg vs Placebo: Odds Ratio (OR): 2.61 (95% CI 1.89 to 3.61), p <0.001, Regression, Logistic

Population analysed: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.

Primary outcome: Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Number. Unit: Participants

Measure	Telcagepant 150 mg n = 317	Telcagepant 300 mg n = 338	Zolmitriptan 5 mg n = 326	Placebo n = 327
Value	170	193	180	120

Telcagepant 150 mg vs Placebo: Odds Ratio (OR): 2.05 (95% CI 1.49 to 2.82), p <0.001, Regression, Logistic
Telcagepant 300 mg vs Placebo: Odds Ratio (OR): 2.37 (95% CI 1.73 to 3.25), p <0.001, Regression, Logistic

Population analysed: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days after last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telcagepant 150 mg	0 of 334 (0%)	66 of 334 (19.8%)	Not reported
Telcagepant 300 mg	0 of 352 (0%)	74 of 352 (21%)	Not reported
Zolmitriptan 5 mg	0 of 345 (0%)	107 of 345 (31%)	Not reported
Placebo	1 of 349 (0.3%)	54 of 349 (15.5%)	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.
Background: PubMed 19036425Ho TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, Koppen H, Winner PK. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 Dec 20;372(9656):2115-23. doi: 10.1016/S0140-6736(08)61626-8. Epub 2008 Nov 25.
Derived from this study: PubMed 21054362Ho TW, Olesen J, Dodick DW, Kost J, Lines C, Ferrari MD. Antimigraine efficacy of telcagepant based on patient's historical triptan response. Headache. 2011 Jan;51(1):64-72. doi: 10.1111/j.1526-4610.2010.01790.x. Epub 2010 Nov 4.
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 potassium 150 mg, Telcagepant potassium 300 mg and Zolmitriptan 5 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 2 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. 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 4 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?

Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose (time frame: 2 hours post-dose). The study lists 7 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 NCT00442936, which also lists 2 linked publications.

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.