Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK0974 · 3 trials · 1 indication
Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
| Arm | Type | Description |
|---|---|---|
| MK0974 50 mg | EXPERIMENTAL | MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack |
| MK0974 150 mg | EXPERIMENTAL | MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack |
| MK0974 300 mg | EXPERIMENTAL | MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack |
| Placebo | PLACEBO_COMPARATOR | Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack |
| MK0974 25 mg | EXPERIMENTAL | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| MK0974 100 mg | EXPERIMENTAL | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| MK0974 200 mg | EXPERIMENTAL | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| MK0974 400 mg | EXPERIMENTAL | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| MK0974 600 mg | EXPERIMENTAL | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Rizatriptan 10 mg | ACTIVE_COMPARATOR | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| 1 | EXPERIMENTAL | MK0974 Tablet |
| 2 | ACTIVE_COMPARATOR | MK0974 Liquid filled capsule |
| Name | Type | Description |
|---|---|---|
| MK0974 50 mg | DRUG | - |
| MK0974 150 mg | DRUG | - |
| MK0974 300 mg | DRUG | - |
| Comparator: Placebo | DRUG | MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo. |
| MK0974 | DRUG | MK0974 25 mg; one orally-administered dose |
| Rizatriptan | DRUG | Rizatriptan 10 mg; one orally-administered dose |
| MK0974 tablet | DRUG | MK0974 280 mg tablet in one of two treatment periods |
| Comparator: MK0974 liquid filled capsule | DRUG | MK0974 300 mg liquid filled capsule in one of two treatment periods |
Inclusion Criteria: * Patient has at least 1 year history of migraine (with or without aura) * Females of childbearing years must use acceptable contraception throughout trial Exclusion Criteria: * Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period) *...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
MK0974 is an investigational small molecule being developed for the acute treatment of migraine. It is a neurology therapeutic that has been studied in clinical trials for migraine relief. As of the available data, MK0974 remains investigational and has not been reported as approved by regulatory authorities.
MK0974 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck has sponsored clinical trials evaluating MK0974 for the acute treatment of migraine.
MK0974 has completed Phase 3 clinical trials for migraine. The development program includes a completed Phase 3 study, a completed Phase 2 dose-finding study, and a completed Phase 1 bioequivalence study. However, MK0974 is still considered investigational and has not been reported as approved.
MK0974 has been studied in three completed clinical trials. NCT00246337 was a Phase 2 dose-finding study in acute migraine with 420 participants. NCT00432237 was a Phase 3 safety and efficacy study in acute migraine with 1703 participants. NCT00966030 was a Phase 1 bioequivalence study comparing tablet and liquid-filled capsule forms with 50 participants.
MK0974 is also known as telcagepant, a name that has been used in scientific literature and clinical trial references. The drug is a small molecule developed by Merck for the acute treatment of migraine, and both names refer to the same investigational compound.