Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00432237 | Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016) | PHASE3 | COMPLETED | 1,703 | — | — | Mar 1, 2007 | Dec 1, 2007 | Jul 3, 2015 | - | — |
| NCT00246337 | A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004) | PHASE2 | COMPLETED | 420 | — | — | Nov 1, 2005 | May 1, 2006 | Nov 2, 2015 | - | — |
| NCT00966030 | Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042) | PHASE1 | COMPLETED | 50 | — | — | Mar 1, 2008 | May 1, 2008 | Jul 7, 2015 | - | — |
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 | 15 | PHASE3 | Atogepant, Topiramate, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1, erenumab-aooe |
| Ki Health Partners. LLC | RVNC | 1 | — | Daxibotulinumtonix A |