SLS-002 for PTSD

Not yet recruiting at 10 trial locations

Overseen By Please visit the website:

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Global Coalition for Adaptive Research

Must not be taking: MAOIs, Opioids, Antipsychotics, others

Disqualifiers: Seizures, Hypertension, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SLS-002, an experimental therapy, to determine its effectiveness for individuals with Post Traumatic Stress Disorder (PTSD). The researchers aim to assess the safety and efficacy of SLS-002 compared to a placebo, which contains no active ingredients, in participants with PTSD. Suitable candidates for this trial include those who can attend treatment visits twice a week initially and have not previously used ketamine. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. The study prohibits the use of specific drugs like monoamine oxidase inhibitors (MAOIs), opioids, psychostimulants, mood stabilizers, and antipsychotics. If you've taken any of these within 30 days before screening, you cannot participate.

Is there any evidence suggesting that SLS-002 is likely to be safe for humans?

Research has shown that SLS-002, a nasal spray form of ketamine, has been tested for safety in conditions such as Major Depressive Disorder with Acute Suicidal Ideation. Previous studies have found that ketamine treatments are usually well-tolerated. Some patients experienced side effects like dizziness, nausea, and increased blood pressure, but these were often mild and temporary. Additionally, SLS-002 has two investigational new drug applications, indicating some confidence in its safety.

Since this treatment is in Phase 2 trials for PTSD, researchers continue to study its safety and effectiveness carefully. Early tests have shown it to be safe enough for a larger group of participants. However, the complete safety profile will become clearer as more people participate in studies like this one. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Unlike standard PTSD treatments, which often involve medications like SSRIs or SNRIs, SLS-002 is unique because it targets the NMDA receptor in the brain. This novel mechanism of action could potentially rapidly alleviate PTSD symptoms by modulating glutamate activity, which is different from the traditional focus on serotonin levels. Researchers are excited about SLS-002 because it offers a new pathway for addressing PTSD, potentially leading to faster relief for patients compared to existing options. This innovative approach could change how PTSD is managed, providing hope for those who haven't found success with current treatments.

What evidence suggests that SLS-002 might be an effective treatment for PTSD?

Research has shown that SLS-002, a nasal spray form of ketamine, may help treat PTSD. In earlier studies, patients using SLS-002 experienced a significant reduction in PTSD symptoms. Specifically, their PTSD severity scores decreased by over 30% from the beginning to 12 weeks later. This trial will compare SLS-002 with a placebo to further evaluate its effectiveness in reducing PTSD symptoms. While these results are promising, more research is needed to confirm its effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive SLS-002 or placebo for PTSD in a 12-week treatment period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

PPD Development, LP

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06816433

NCT06816433 | Department of Defense PTSD Adaptive ... ≥30% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale ...

2. prnewswire.com prnewswire.com/news-releases/seelos-therapeutics-announces-the-selection-of-sls-002-intranasal-racemic-ketamine-for-inclusion-in-the-us-department-of-defenses-adaptive-platform-trial-to-evaluate-potential-treatments-for-post-traumatic-stress-disorder-pt-301997327.html

Seelos Therapeutics Announces the Selection of SLS-002 ... SLS-002 (intranasal racemic ketamine) has been selected for inclusion in an adaptive platform trial to evaluate treatments for post-traumatic stress disorder ( ...

3. synapse.patsnap.com synapse.patsnap.com/article/seelos-therapeutics-fda-phase-ii-meeting-outcome-for-sls-002-study-adjustments

FDA Phase II Meeting Outcome for SLS-002 Study ... Seelos aims to address this gap with SLS-002, an intranasal formulation of racemic ketamine, which has shown promise as a rapid and effective ...

4. seelostherapeutics.com seelostherapeutics.com/sls-002-ketamine/

SLS-002 (intranasal ketamine) - SLS-002 (intranasal ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05422612

NCT05422612 | Department of Defense PTSD Adaptive ... The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome. 12 ...

6. firstwordpharma.com firstwordpharma.com/story/5804199

Seelos Therapeutics Announces the Selection of SLS-002 ... The design of the trial entails a 30-day screening period, a 12-week treatment period and a 4-week safety follow-up and will collect data to ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40883964/

A nonrandomized open-label clinical trial Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical ...

8. prnewswire.com prnewswire.com/news-releases/seelos-therapeutics-announces-the-signing-of-a-material-transfer-agreement-with-us-army-medical-materiel-development-activity-usammda-to-evaluate-sls-002-for-treatment-of-ptsd-302256228.html

Seelos Therapeutics announces the signing of a Material ... SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior ...