Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
18. september 2018 opdateret af: Merck Sharp & Dohme LLC
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
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, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1935
Fase
- Fase 3
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Telcagepant 140 mg
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.
|
Telcagepant 140 mg tablets
|
|
Eksperimentel: Telcagepant 280 mg
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.
|
Telcagepant 280 mg tablets
|
|
Placebo komparator: Control Group 1
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.
|
Telcagepant 140 mg tablets
Placebo tabletter
|
|
Placebo komparator: Control Group 2
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.
|
Telcagepant 140 mg tablets
Placebo tabletter
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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
Tidsramme: 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.
|
2 hours post-dose (up to 6 months)
|
|
Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
Tidsramme: 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.
|
2 hours post-dose (up to 6 months)
|
|
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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
Tidsramme: 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.
|
Up to the 4th dose of study medication (up to 6 months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Tidsramme: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
|
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.
|
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)
Tidsramme: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
|
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.
|
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)
Tidsramme: 2 hours post-dose for the first migraine attack (up to 6 months)
|
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.
|
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)
Tidsramme: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
|
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.
|
From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. august 2008
Primær færdiggørelse (Faktiske)
25. marts 2009
Studieafslutning (Faktiske)
25. marts 2009
Datoer for studieregistrering
Først indsendt
15. maj 2007
Først indsendt, der opfyldte QC-kriterier
6. juni 2007
Først opslået (Skøn)
7. juni 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0974-031
- MK-0974-031 (Anden identifikator: Merck Protocol Number)
- 2007_546 (Anden identifikator: Telerx ID Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Studiedata/dokumenter
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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