Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD (MPLONG)

• ClinicalTrials.gov Identifier: NCT05066282
• Recruitment Status: Enrolling by invitation
• First Posted: October 4, 2021
• Last Update Posted: January 24, 2024
• Sponsor: Lykos Therapeutics
• Information provided by (Responsible Party): Lykos Therapeutics

Tracking Information

• First Submitted Date: September 23, 2021
• First Posted Date: October 4, 2021
• Last Update Posted Date: January 24, 2024
• Actual Study Start Date: March 1, 2021
• Estimated Primary Completion Date: September 25, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 23, 2021)

Clinician Administered PTSD Scale for DSM-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study [ Time Frame: LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1) ]

The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD
• Official Title: Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
• Brief Summary: Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder (PTSD), independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity. Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.
• Detailed Description: The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and education organization working as a clinical trial sponsor to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to therapy for treatment of posttraumatic stress disorder (PTSD). Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic PTSD, independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity. The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to LTFU IR Assessments (Visit 1). Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants with past posttraumatic stress disorder (PTSD) who have completed at least one Experimental Session in the main study protocol.
• Condition: PTSD
• Intervention: Not Provided
• Study Groups/Cohorts: Participants with past PTSD who received IMP in the main study
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 23, 2021): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 25, 2024
• Estimated Primary Completion Date: September 25, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
3. Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits

Exclusion Criteria:

1. Are not able to give adequate informed consent
2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Israel, United States

Administrative Information

• NCT Number: NCT05066282
• Other Study ID Numbers: MPLONG
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lykos Therapeutics
• Original Responsible Party: Multidisciplinary Association for Psychedelic Studies
• Current Study Sponsor: Lykos Therapeutics
• Original Study Sponsor: Multidisciplinary Association for Psychedelic Studies
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Lykos Therapeutics
• Verification Date: January 2024