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

Completed

Phase 3 Results

Trial Description

The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.

Conditions

Interventions

  • Comparator: MK0974 Drug
    Intervention Desc: MK0974 (300 mg soft gel capsules or 280 mg tablets)
    ARM 1: Kind: Experimental
    Label: 1
    Description: Crossover study: All migraine attacks to be treated with up to 12 doses of MK0974 over the 1st six week treatment period. This will be followed by up to 12 doses of acetaminophen/paracetamol (1000 mg dry filled capsules) over the 2nd six week treatment period.
    ARM 2: Kind: Experimental
    Label: 2
    Description: Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.
  • Comparator: acetaminophen Drug
    Intervention Desc: acetaminophen (500 mg X 2 dosage units)
    ARM 1: Kind: Experimental
    Label: 1
    Description: Crossover study: All migraine attacks to be treated with up to 12 doses of MK0974 over the 1st six week treatment period. This will be followed by up to 12 doses of acetaminophen/paracetamol (1000 mg dry filled capsules) over the 2nd six week treatment period.
    ARM 2: Kind: Experimental
    Label: 2
    Description: Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.
  • Comparator: Placebo Drug
    Intervention Desc: placebo (0 mg soft gel capsules)
    ARM 1: Kind: Experimental
    Label: 2
    Description: Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.
  • Telcagepant Drug
    Intervention Desc: Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
    ARM 1: Kind: Experimental
    Label: Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
    Description: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
    ARM 2: Kind: Experimental
    Label: Placebo and APAP 1000 mg→Telcagepant 300 mg
    Description: Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
  • Acetaminophen/Paracetamol Drug
    Intervention Desc: Acetaminophen/Paracetamol (500 mg X 2 dosage units)
    ARM 1: Kind: Experimental
    Label: Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
    Description: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
    ARM 2: Kind: Experimental
    Label: Placebo and APAP 1000 mg→Telcagepant 300 mg
    Description: Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
  • Placebo to Telcagepant Drug
    Intervention Desc: Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
    ARM 1: Kind: Experimental
    Label: Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
    Description: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
    ARM 2: Kind: Experimental
    Label: Placebo and APAP 1000 mg→Telcagepant 300 mg
    Description: Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
  • Placebo to Acetaminophen/Paracetamol Drug
    Intervention Desc: Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)
    ARM 1: Kind: Experimental
    Label: Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
    Description: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
    ARM 2: Kind: Experimental
    Label: Placebo and APAP 1000 mg→Telcagepant 300 mg
    Description: Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary To evaluate the efficacy of MK0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours post dose. 2 hours post dose No
Secondary Number of confirmed vascular event within 48 hours after any dose of study medication. following 12 weeks of treatment Yes
Primary Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1) 2 hours post-dose (Up to 6 weeks) No
Primary Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose Within 14 days of any dose of study medication (Up to 16 weeks) Yes
Primary Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose Up to 48 hours post-dose (Up to 14 weeks) Yes
Secondary Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1) 2 hours post-dose (Up to 6 weeks) No
Secondary Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose Up to 48 hours after the dose of any study medication (Up to 14 weeks) Yes
Secondary Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) 2 hours post-dose (Up to 6 weeks) No
Secondary Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) 2 Hours post-dose (Up to 6 weeks) No
Secondary Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1) 2 hours post-dose (Up to 6 weeks) No
Secondary Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose Up to 24 hours post-dose (Up to 14 weeks) No

Sponsors