Clinical Trial 46496

Oceanside, CA 92056


Summary:

Study Synopsis: Randomized, Double Bind, of Troriluzole for Obsessive Compulsive Disorder 

Study Drug: 2 arms- Placebo or Troriluzole (280mg QD, after 2 weeks = 200mg QD) taken in the morning with food but can be changed to evenings per Doctor’s permission.  

Study Length: total treatment period is 10 weeks, with a 42-day screen and 14 day follow up.  

Compensation: $100 after each completed appointment

Key Points: 

  • Subjects can roll over into extension study for 48 weeks after 

Inclusionary: 

  • 18-65 years old 

  • DSM5 Dx of OCD ≥ 1 year 

  • Currently on an SSRI at least 8 weeks at screening and 12 weeks at baseline 

  • Currently experiencing non-response or inadequate response to their current SOC medication 

  • Stable dose of other medications for at least 12 weeks prior to screen 

  • CGI-S score of ≥ 4 at screening and baseline, “pass” the SAFER interview performed by CTNI, and a minimum of 6 years of education. 

Exclusionary: 

  • No history of psychosurgery, substance abuse, stroke/seizure 

  • No history of liver disease, heart, gastrointestinal, hematologic, or diabetes 

  • No BMI >40 kg/m2 

  • No vitamin B12/folate deficiency 

  • No positive cannabis or drug test 

  • No other psychological diagnosis than OCD 

  • Total BABS score >17  

  • No active MDD or anxiety 

  • No suicidal behavior in the last 12 months 

Allowed ConMeds: 

- Zolpidem tartrate (Ambien): up to 10 mg at bedtime (HS) as needed (prn);  

-  Zolpidem tartrate extended-release (Ambien CR): up to 12.5 mg at HS prn;  

- Zaleplon (Sonata): up to 20 mg at HS prn  

- Eszopiclone (Lunesta): up to 3 mg at HS prn.  

- Oral contraceptives which contain ethinyl estradiol 

- Lorazepam (up to 1 mg/day) or equivalent benzodiazepine for sleep and anxiety is allowed if used at a stable dose for at least 3 months prior to screening 

 

Disallowed ConMeds up to 4 weeks prior: 

-stimulants, neuroleptics, mood stabilizer and glutamate agents (e.g. gabapentin, pregabalin, topiramate, lamotrigine, N- acetylcysteine, ketamine, memantine, sodium 

Disallowed ConMeds minimum 5 half-lives prior: 

 

- Strong to moderate CYP1A2 inhibitors like Fluvoxamine 

- Strong to moderate CYP1A2 inducers  

- Hepatotoxic drugs (e.g., allopurinol, methyldopa, sulfaszalzine)  




Qualified Participants May Receive:

- Compensation: $100 after each completed appointment.

- Placebo or Troriluzole (280mg QD, after 2 weeks = 200mg QD) in combination with current ADT.

-Travel assistance if participants need a ride.

 


Available At:

Excell Research
3998 Vista Way, Suite 100
Oceanside, CA 92056
View Clinic Location

 


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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.