SCI-110 for Tourette Syndrome

Not yet recruiting at 3 trial locations

Overseen By Adi Zuloff-Shani, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SciSparc

Must not be taking: Cannabis, Cannabinoid-based medicine

Disqualifiers: Severe psychiatric conditions, Substance abuse, Severe cardiac diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 3 5 6 7}

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

My medication and treatment for tics have been stable for 6 weeks, and I agree to keep them unchanged during the study.

I am not pregnant and will use effective birth control during the study.

Signed written informed consent and willingness to comply with treatment and follow-up procedures

Exclusion Criteria

I have used cannabis or cannabinoid-based medicine in the last 30 days.

You have severe mental health conditions like developmental disability, psychotic illness, or bipolar disorder, as determined by the investigator.

I am currently receiving therapy for my tics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral SCI-110 or placebo in a double-blind, cross-over design

12 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Regular visits for assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SCI-110

Trial Overview

The trial is testing SCI-110, a cannabinoid-based medicine, against a placebo to see if it's effective, safe, and tolerable for treating Tourette Syndrome symptoms. Participants will randomly receive either SCI-110 or an inactive substance (placebo).

How Is the Trial Designed?

Group I: SCI-110 Experimental Treatment 1 Intervention

Cannabinoid-based medication consisting of Dronabinol and PEA

Group II: Dronabinol Placebo Group 1 Intervention

Placebo matched in taste, odour and appearance to SCI-110

Who Is Running the Clinical Trial?

SciSparc

Lead Sponsor

Trials

5

Recruited

330+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03066193

Efficacy of a Therapeutic Combination of Dronabinol and ...

A 12-week, investigator-initiated, open-label trial of a therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03066193?cond=%22Nervous%20System%20Disease%22&intr=%22Palmidrol%22&viewType=Table&rank=2

Efficacy of a Therapeutic Combination of Dronabinol and PEA for ...

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34340527/

A Phase-2 Pilot Study of a Therapeutic Combination of Δ 9

A 12-week uncontrolled trial of THX-110 (maximum daily Δ 9 -THC dose, 10 mg, and a constant 800-mg dose of PEA) in 16 adults with Tourette's syndrome was ...

4.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.neuropsych.19080178

A Phase-2 Pilot Study of a Therapeutic Combination of Δ 9

Our goals for this pilot study were to provide initial safety, feasibility, and tolerability data on THX-110 in a Tourette's syndrome population ...

5.

ctv.veeva.com

ctv.veeva.com/study/efficacy-of-a-therapeutic-combination-of-dronabinol-and-pea-for-tourette-syndrome

Efficacy of a Therapeutic Combination of Dronabinol and PEA ...

This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05126888

SCI-110 in the Treatment of Tourette Syndrome

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

7.

neurologylive.com

neurologylive.com/view/cannabis-agent-sci-110-meets-primary-end-points-phase-2-interim-analysis-alzheimer-agitation

Cannabis Agent SCI-110 Meets Primary End Points in ...

SCI-110 not only met its primary safety end points, but the agent showed benefits on secondary outcomes such as need to use rescue ...