MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 13 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada.
The purpose of this study is to provide the final training for our co-therapy teams.
On February 13, 2018, Senior Clinical Research Associate Charlotte Harrison of MAPS Public Benefit Corporation (MPBC) traveled to Colorado for a Site Initiation Visit of the open-label lead-in study site in Boulder where we will conduct MDMA-assisted psychotherapy for PTSD.
These Study Initiation Visits provide training on study procedures to study sites where new co-therapy teams will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS' therapy training team.
Charlotte also led an Interim Monitoring Visit on February 12 and 14 at the open-label lead-in study site in Fort Collins, Colorado.
The study site in Fort Collins has conducted experimental treatment sessions with two participants, and the New Orleans study site has completed their first experimental treatment session, and other sites will start enrolling participants soon.
The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
A total of 7 study sites have been granted a Schedule I license by the U.S. Drug Enforcement Administration (DEA):
- Los Angeles, CA
- San Francisco, CA
- Fort Collins, CO
- New Orleans, LA
- New York, NY
- Charleston, SC
The Phase 3 trials build on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD. Once approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting.
Within the next month, sites in Charleston, South Carolina and in New York City will begin screening and recruiting participants for enrollment.
A total of 6 study sites have received the necessary study drug:
- San Francisco, CA (received Jan.9)
- Los Angeles, CA (received Jan. 25)
- Fort Collins, CO(received Dec. 19)
- New Orleans, LA (received Dec. 20)
- Charleston, SC (received Feb. 21)
On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.
On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.
MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $20+ million in hand or in multi-year pledges, there's still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will likely require additional funds, with MAPS beginning negotiations with EMA on March 1. EMA agreement is anticipated by the end of Summer 2018.
There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: