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Enrolling by invitationPhase 3

An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD

Key facts

Who runs it
Transcend Therapeutics
Where
Austin, Creve Coeur, Draper, El Paso, Evergreen, Independence, Jacksonville, Lauderhill, Little Rock, Los Angeles, Maitland, Montclair, Orem, Orlando, Plymouth Meeting, Toms River, and Worcester, United StatesSee the 17 sites
Trial code
Status
Enrolling by invitation
Phase
Phase 3
People taking part
300 people, planned
Started
22 Jun 2026
Expected to end
Jan 2029
Type of study
Interventional
Treatments tested
  • TSND-201
Record updated
4 September 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site
  • Proficient in communication (verbal and reading) to complete interviews and written questionnaires
  • Agree to not participate in any other interventional clinical trials for the duration of this study

Who cannot take part

  • Experienced an intolerable side effect following dosing with TSND-201 in the prior study
  • Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation
  • Change or development of any physical or psychological finding that would make participant unsuitable for study

Where in United States

  • Austin Clinical Trial PartnersAustin, United StatesEnrolling by invitation
  • Arch Clinical TrialsCreve Coeur, United StatesEnrolling by invitation
  • Cedar Clinical ResearchDraper, United StatesEnrolling by invitation
  • Haracec Clinical ResearchEl Paso, United StatesEnrolling by invitation
  • Starlight Clinical ResearchEvergreen, United StatesEnrolling by invitation
  • Insight Clinical TrialsIndependence, United StatesEnrolling by invitation
  • Clinical Neuroscience Solutions - JacksonvilleJacksonville, United StatesEnrolling by invitation
  • Segal TrialsLauderhill, United StatesEnrolling by invitation
  • Preferred Research PartnersLittle Rock, United StatesEnrolling by invitation
  • CalNeuro Research GroupLos Angeles, United StatesEnrolling by invitation
  • Accel Clinical ResearchMaitland, United StatesEnrolling by invitation
  • Catalina Research InstituteMontclair, United StatesEnrolling by invitation
  • Inner Space ResearchOrem, United StatesEnrolling by invitation
  • CNS HealthcareOrlando, United StatesEnrolling by invitation
  • Flourish ResearchPlymouth Meeting, United StatesEnrolling by invitation
  • Bio Behavioral HealthToms River, United StatesEnrolling by invitation
  • Vitalix ClinicalWorcester, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial.

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Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.

The group in the trial

  • TSND-201Treatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD
Record updated
4 September 2026