IMPACT-EXT: Long-term extension

• Research type

  Research Study

• Full title

  A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments with Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

• IRAS ID

  1008896

• Contact name

  Amanda Jones

• Contact email

  amanda@transcendtherapeutics.com

• Sponsor organisation

  Transcend Therapeutics

• Research summary

  This is an open-label 52-week extension study of participants who previously completed a Transcend-sponsored clinical trial with methylone as a treatment for PTSD (eg, IMPACT-1 or IMPACT-2). The aim of this study is to evaluate the long-term durability of methylone as a treatment for PTSD.
  Upon successful completion of the final study visit in the prior methylone study, participants may be eligible to enroll in this study. Participants will have study visits approximately every 4 weeks to assess for PTSD symptoms / relapse. Participants who meet relapse criteria may be given a course of methylone treatment.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0899

• Date of REC Opinion

  16 Nov 2023

• REC opinion

  Further Information Favourable Opinion