Phase 2 double blind, ENX-102 and dose response in GAD patients
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ENX-102 and Determine a Dose-response for ENX-102 in Patients with Generalized Anxiety Disorder (GAD).
IRAS ID
1010593
Contact name
Eve Taylor
Contact email
Sponsor organisation
Engrail Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose.
ENX-102 has been demonstrated to be safe and well-tolerated at multiple doses up to and including 5 mg administered once daily for 12 days in healthy volunteers. Eligible patients will be randomized 1:1:1:1 to placebo or one of three doses of ENX-102 (0.5, 1, or 3 mg).Following randomization, patients will enter a 28-day fixed dose Treatment Period during which they will self-administer study drug once daily starting in the evening of Day 1 through the evening of Day 28. The Treatment Period will be followed by a 14-day Taper period in which patients will receive progressively lower doses of ENX-102 or placebo (if randomized to placebo). The Taper period will be followed by a 14-day Follow-up Period. Patients will return for outpatient assessments on Day 15 (±1 day), Day 29 (±1 day), Day 43 (± 1 days), and Day 56 (± 2 days). In addition, a remote visit will be conducted on Day 8.The patient will receive education on the placebo effect using the Placebo-Control Response Script© (PCRS) to minimize expectation bias in the study. Throughout the study, adverse events (AEs) and concomitant medications will be recorded on all study days.
A total of approximately 36 patients (9 patients/group across 4 groups) with GAD will be enrolled. The sponsor of this trial is Engrail Therapeutics.REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0313
Date of REC Opinion
1 Nov 2024
REC opinion
Further Information Favourable Opinion