Neurothera Labs Inc.
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.
It is believed that SCI-110 will be a valuable treatment option, especially for t those subjects with TS, who do not benefit from or do not tolerate first-line treatment with antipsychotics. Since there is evidence that currently available CBM improves not only tics, but also psychiatric comorbidities, SCI-110 might be even more beneficial to improve a broader spectrum of symptoms resulting in both improved quality of life and decreased disease related costs. Moreover, PEA was shown to minimize AEs associated with cannabinoids use and to reduce their required effective dose (data not published…
Inclusion Criteria: 1. Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 2. Male and female subjects with an age between ≥18 and ≤65 years 3. Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \>14 4. Clinical Global Impression-Severity Score (CGI-S) ≥4 5. Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study 6. Signed written in…
SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg. Maximum dose 20mg Dronabinol and 800mg PEA a day.
Pill that matches in taste, odour and appearance to SCI-110 active pills
Arctuva estimate
Verify or correct the compensation shown for this listing.