Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telcagepant soft · 1 trial · 1 indication
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.
Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (\>=180 mm Hg and 20 mm Hg increase OR \<=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (\>=105 mm Hg and 15 mm Hg increase OR \<=50 mm Hg and 15 mm Hg decrease), Pulse (\>=120 beats per minute \[bpm\] and 15 bpm increase OR \<=50 bpm and 15 bpm decrease), Body Temperature (\>38º C \[oral equivalent\]) and Respiratory Rate (\>25 or increase of 10 OR \<5 or decrease of 10 \[per minute\]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Telcagepant 280 mg/300 mg | EXPERIMENTAL | Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. |
| Rizatriptan 10 mg | ACTIVE_COMPARATOR | Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months. |
| Name | Type | Description |
|---|---|---|
| Telcagepant 300 mg soft gel capsules | DRUG | One capsule taken orally at onset of migraine |
| Telcagepant 280 mg tablets | DRUG | One tablet taken orally at onset of migraine |
| Rizatriptan 10 mg tablets | DRUG | One tablet taken orally at onset of migraine |
| Placebo to telcagepant capsules | DRUG | One capsule taken orally at onset of migraine |
| Placebo to telcagepant tablets | DRUG | One tablet taken orally at onset of migraine |
| Placebo to rizatriptan tablets | DRUG | One tablet taken orally at onset of migraine |
Inclusion Criteria: * At least 1 year history of migraine (with or without aura) * Females of child bearing potential must use acceptable contraception throughout trial * In general good health based on screening assessment Exclusion Criteria: * Pregnant/breast-feeding (or is a female expecting t...
| 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 |
Telcagepant is an investigational small molecule being developed for the acute treatment of migraine in adults. It is intended to relieve migraine symptoms, and it has been studied in a Phase 3 clinical trial. Telcagepant is not approved and remains in clinical development.
Telcagepant is a small molecule that targets the calcitonin gene-related peptide (CGRP) receptor. By blocking this receptor, it is designed to inhibit the effects of CGRP, a protein involved in migraine pain transmission. This mechanism is being evaluated for acute migraine treatment.
Telcagepant is being developed by Merck & Company, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of Telcagepant for migraine.
Telcagepant is in Phase 3 clinical development. It has completed a Phase 3 trial, but it is not yet approved by regulatory authorities. The drug remains investigational and is still being studied for the acute treatment of migraine.
Telcagepant has been studied in a Phase 3 clinical trial with the identifier NCT00443209. This was a long-term safety study in adult participants with acute migraine, enrolling 1,068 participants. The trial was randomized, double-blind, and active-controlled, and it has been completed.
Yes, Telcagepant is also known as MK-0974. The clinical trial NCT00443209 is titled 'Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012),' confirming that both names refer to the same investigational drug.