SLS-002 for PTSD

Recruiting at 6 trial locations

Overseen By Please visit the website:

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Global Coalition for Adaptive Research

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design. Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.

Eligibility Criteria

This trial is for individuals with PTSD who can avoid alcohol and cannabis on dosing days, are able to use intranasal medication, and commit to frequent clinic visits. Excluded are those with extreme BMI values, uncontrolled hypertension or other illnesses that could affect safety results, known sensitivities to the treatment, a history of seizures or serious heart issues, nasal absorption impairments, certain bladder conditions, prior recreational ketamine use (medical anesthesia usage allowed), or unwillingness to stop certain medications.

Inclusion Criteria

Is able to refrain from alcohol or cannabis consumption/use on dosing days

I can use nasal sprays or similar treatments.

I can attend all treatment sessions and won't drive or use machinery for 24 hours after.

Exclusion Criteria

Has a body mass index >40 or <18 kg/m2 at Screening

Has known, uncontrolled hypertension or blood pressure that, in the investigator's judgment, should exclude the subject at Screening or Baseline (blood pressure may be repeated as per the site's standard operating procedures)

I have a health condition that could affect the study's safety results.

Treatment Details

Interventions

• SLS-002

Trial Overview The study tests SLS-002's safety and effectiveness against PTSD compared to a placebo in a double-blind setup where neither participants nor researchers know who gets what. It's part of an adaptive platform trial aiming at finding new treatments for PTSD by evaluating multiple interventions simultaneously.

Participant Groups

Group I: Intervention D: SLS-002 Experimental Treatment 1 Intervention

Group II: Intervention D: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Global Coalition for Adaptive Research

Lead Sponsor

Trials

7

Recruited

22,600+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+

Cambridge Cognition Ltd

Industry Sponsor

Trials

17

Recruited

4,700+

Citeline

Collaborator

Trials

5

Recruited

1,600+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Idorsia Pharmaceuticals Ltd.

Industry Sponsor

Trials

124

Recruited

36,400+

Antonio Olivieri

Idorsia Pharmaceuticals Ltd.

Chief Medical Officer since 2024

Not specified

André C. Muller

Idorsia Pharmaceuticals Ltd.

Chief Executive Officer

Not specified

Citeline

Industry Sponsor

Trials

5

Recruited

1,600+