A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250

• Status: Terminated
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

Summary

A trial to assess the efficacy, safety, tolerability and effect of a drug (code name TRV250) given as an injection to subjects who have received an injection of a drug called glyceryl trinitrate (GTN) which is clinically known to induce an immediate headache of short duration (under 30 minutes), known as the "GTN immediate headache"

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trevena Inc.

Criteria

Inclusion Criteria:

• Patient is male or female, aged between 18 and 55 years inclusive.

• Patient's Body Mass Index (BMI) is between 18 and 32 kg/m2 inclusive.

• Patient should have a clinical diagnosis of migraine without aura (IHS criteria 1.1) and experience between 1 migraine attack every other month to 8 migraine attacks per month. They should have had a positive outcome with Triptans, for their migraine attacks (Triptan Responders).

Exclusion Criteria:

• Patient has previous exposure to TRV250.

• Abnormal EEG at screening or risk factors of increased seizure potential, such as previous seizures, history of febrile seizures, cerebral tumor, stroke, cerebrovascular disease, or significant traumatic brain injury.

• Patient with a history of hypotension or hypertension, including where this is currently under control.

• Patient taking prophylactic migraine treatments such as beta blockers 28 days before GTN infusion on Day 1.

• Resting heart rate <45 beats per minute on assessment of vital signs at screening or pre-GTN infusion on Day 1.

• QTcF >450 msec at screening (mean of three ECGs) or pre-GTN infusion on Day 1.

• Patient with another headache disorder such as menstrual migraine, chronic migraine, cluster headache, tension headache or other chronic headache states.

• Patient who have a history, or family history of any vascular intracranial lesion such as subarachnoid aneurysm or similar and patients with a relevant neurological history.

• Patients who have any allergies/contraindications for Triptan administration.