MM120-301 -PANORAMA
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) with a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults with Generalized Anxiety Disorder – Panorama
IRAS ID
1010642
Contact name
Medical Affairs
Contact email
Sponsor organisation
Mind Medicine Inc.
Research summary
Generalised Anxiety Disorder (GAD) is a serious condition with an unmet medical need. The currently available treatments for GAD have unwanted side effects or are not effective for many people. MM120 may be an alternative treatment option that could be an improvement over existing treatments. The purpose of this study is to evaluate the safety and effectiveness of MM120 in people with GAD, at the dose that was determined from the earlier study. The study will also look at how long a single treatment with MM120 provides anxiety symptom relief and when participants may need to be re-dosed with MM120 over the 40 weeks follow-up period. Persons who are between 18 and 74 years of age with a diagnosis of GAD, who want to participate in the study, will have a series of evaluations to determine if they are eligible to enrol in the study. The study consists of a 12-week part (Part A) in which participants will be assigned to a dose group randomly (like drawing straws), to receive MM120 (50 µg MM120 or 100 µg MM120) or placebo (the “dummy drug” that looks like MM120 but does not have any MM120 in it). They will be randomized to receive a single dose of either 100 µg MM120, 50 µg MM120, or matching placebo. The study is considered double-blind, which means that neither the participant nor the study doctor know which study drug a participant receives. The second part of the study, Part B, is a 40-week open-label extension (OLE). All participants in this part of the study will receive 100 µg MM120, taken orally. During treatment, a participant will have assessments regularly performed such as physical exams, blood levels, quality of life questionnaires and other procedures. If a participant withdraws from the study, they are encouraged to continue to have visits & contact with their study doctor to monitor their health.
This study is being funded by Mind Medicine, Inc. and will be conducted at approximately 35 study centres globally.REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0100
Date of REC Opinion
30 Jan 2025
REC opinion
Favourable Opinion