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...
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Telcagepant soft is an investigational small molecule being studied for the treatment of acute migraine in adults. It was developed as an oral therapy for migraine attacks and was evaluated in a Phase 3 clinical program. It is not an approved medicine.
Telcagepant soft targets CALCRL, also known as the calcitonin gene-related peptide receptor. It acts as an antagonist at this receptor, meaning it blocks receptor signaling. This mechanism was investigated for interrupting migraine attack pathways without the vasoconstriction associated with older acute migraine treatments.
Telcagepant soft was developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the clinical development program for the asset, including the Phase 3 long-term safety study conducted in adults with acute migraine.
Telcagepant soft reached Phase 3 clinical development. The program included one completed Phase 3 trial, and no trials are currently active. The asset is investigational and is not an FDA-approved treatment for migraine or any other indication.
Telcagepant soft was studied in NCT00443209, a Phase 3 long-term safety study titled Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012). The trial was completed, enrolled 1,068 participants aged 18 years and older, and used an active-controlled, randomized, double-blind design.