SCI-110 in the Treatment of Tourette Syndrome

NCT05126888 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-04-21

No results posted yet for this study

Summary

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

Conditions

  • Tourette Syndrome

Interventions

DRUG

SCI-110

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.

OTHER

Placebo

Pill that matches in taste, odour and appearance to SCI-110 active pills

Sponsors & Collaborators

  • Neurothera Labs Inc.

    lead INDUSTRY

Principal Investigators

  • Kirsten R Müller-Vahl, PhD. MD · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-10-31
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05126888 on ClinicalTrials.gov