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:
Inclusionary:
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 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
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)