SCI-110 in the Treatment of Tourette Syndrome

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Neurothera Labs Inc.
Study ID
NCT05126888
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SCI-110 — DRUG
    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.
  • Placebo — OTHER
    Pill that matches in taste, odour and appearance to SCI-110 active pills

Study Details

To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2025
Primary completion
Oct 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: SCI-110
    Cannabinoid-based medication consisting of Dronabinol and PEA
  • Placebo Comparator: Dronabinol
    Placebo matched in taste, odour and appearance to SCI-110

Primary Outcome Measure

Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) [ Time Frame: At baseline and 12 weeks after start of treatment in both arms. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Child Study Center - NIHB 205New HavenConnecticut06519
Michael Bloch, MD, MS
[email protected]
203-745-9921
Angeli Landeros-Weisenberger, MD
[email protected]
203-745-9921

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By research site
Yale Child Study Center - NIHB 205· New Haven, CT

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