Efficacy, safety, tolerability and pharmacokinetics of TRV-250
Research type
Research Study
Full title
A Phase 1, two-part, single dose, randomised, double-blind, placebo-controlled, parallel study to evaluate the efficacy, safety, tolerability and pharmacokinetics of subcutaneous TRV250 following glyceryl trinitrate infusion.
IRAS ID
265772
Contact name
Dileep Dasyam
Contact email
Sponsor organisation
Trevena Inc
Eudract number
2019-002972-14
Duration of Study in the UK
2 years, 10 months, 13 days
Research summary
The purpose of this study is to test a drug called TRV250 (the ‘study drug’) that is being developed for the treatment of migraine. The study compound being tested is a new type of migraine treatment called TRV250. TRV250 works in a different way in the body compared to previously marketed medicines which are used for migraine treatment. In the past, drugs which work in a similar way to the study drug TRV250 have been tested in animals and humans and caused seizures (fits), which meant the drugs were not developed further. Based on data from animals, TRV250 could be an effective drug for a migraine attack with a lower risk of causing seizures (fits) than other drugs of this type. Nitroglycerin, also referred to as GTN, can be used for the study of headache.
Research studies have demonstrated that GTN administration at 0.5µg/kg/min to a person who is currently well, induces an immediate headache of short duration, referred to as the “GTN immediate headache”. Patients with a history of migraine may additionally develop a migraine headache a few hours after GTN administration referred to as “GTN delayed headache”. The delayed headache is most commonly seen in migraine patients and has several features of the person’s typical migraine.
In this study, we will investigate whether the study drug is effective at treating a migraine type headache that has been induced with GTN administration. The main aims of this study are:
To assess the effect of the study drug on a migraine headache induced by GTN administration.
To assess the safety and tolerability of the study drug.
To see how the body absorbs and removes the study drug.REC name
Wales REC 1
REC reference
19/WA/0184
Date of REC Opinion
22 Aug 2019
REC opinion
Further Information Favourable Opinion