SCI-110 for Tourette Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cannabinoid-based treatment called SCI-110 for individuals with Tourette syndrome, a condition causing involuntary movements and sounds known as tics. The trial aims to assess the treatment's effectiveness, safety, and tolerability compared to a placebo (a treatment with no active drug). Individuals diagnosed with Tourette syndrome who have stable medication use for their tics may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important early findings.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications, but they must be on a stable dose for at least 6 weeks before the study and remain stable during the study.
Is there any evidence suggesting that SCI-110 is likely to be safe for humans?
Research has shown that SCI-110, a treatment made from cannabinoids, appears safe for people with Tourette syndrome. In a study with a small group of patients, SCI-110 was well-tolerated over 12 weeks, with most participants experiencing no serious side effects.
Although some mild side effects were reported, the treatment met its main safety goals. This suggests that SCI-110 could be a safe option for managing Tourette syndrome symptoms, although further research is needed to confirm these results.12345Why do researchers think this study treatment might be promising for Tourette syndrome?
Unlike the standard treatments for Tourette Syndrome, which often include antipsychotics and behavioral therapies, SCI-110 introduces a cannabinoid-based approach. SCI-110 combines Dronabinol, a synthetic form of THC, with PEA (palmitoylethanolamide), potentially offering a dual mechanism of action that targets neurological pathways differently. Researchers are excited because this combination could provide relief with fewer side effects, tapping into the endocannabinoid system to manage symptoms more naturally. This novel approach might offer an alternative for patients who don't respond well to current treatments.
What evidence suggests that SCI-110 might be an effective treatment for Tourette syndrome?
Research has shown that the combination of Dronabinol and PEA, which form SCI-110, might help people with Tourette syndrome. In a 12-week study with 18 adults, this combination reduced tics, which are sudden, repetitive movements or sounds. Another study with 16 adults also demonstrated improvements in tic severity. These findings suggest that SCI-110, which participants in this trial may receive, could help manage Tourette syndrome symptoms. Although more research is needed, early results are promising for those considering this treatment.23567
Who Is on the Research Team?
Kirsten R Müller-Vahl, PhD. MD
Principal Investigator
Hannover Medical School
Are You a Good Fit for This Trial?
Adults aged 18-65 with Tourette Syndrome, having moderate to severe tics and a willingness to follow study procedures. Participants must have stable medication doses for at least 6 weeks prior and agree to maintain them during the trial. Women must not be pregnant or breastfeeding and use reliable contraception; men should use condoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily oral SCI-110 or placebo in a double-blind, cross-over design
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- SCI-110
Find a Clinic Near You
Who Is Running the Clinical Trial?
SciSparc
Lead Sponsor