Health TrialsbyHealthPanel

SCI-110 in the Treatment of Tourette Syndrome

ConditionTourette Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeurothera Labs Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)

Male and female subjects with an age between ≥18 and ≤65 years

Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) >14

Clinical Global Impression-Severity Score (CGI-S) ≥4

Disqualifiers

Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, and anxiety disorder when unstable or in need of an initial adjustment for a therapy-according to the investigator's judgment

Presence of severe psychiatric conditions such as developmental disability, psychotic illness and bipolar disorder- according to the investigator's judgment

Ongoing behavioural treatment for tics

History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: SCI-110Experimental treatment 1 intervention
Group B: DronabinolPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS)

Absolute change from baseline in revised version of YGTSS-R-TTS as a continuous endpoint at week 12 of the respective treatment period. The Global Severity Score has a range of 0- 100. A higher score on the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.

Time frame
At baseline and 12 weeks after start of treatment in both arms.

Secondary outcomes

1

Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 20%

Response to treatment according to YGTSS-R-TTS of at least 20% reduction (compared to baseline) The responder criterion defined as a more severe Tic, or a greater impact the Tic has on the person's life The Global Severity Score has a range of 0- 100. A higher score the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.

Time frame
At baseline and 12 weeks after start of treatment in both arms.
2

Percent reduction in Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS) of at least 30%, 35% and 50%

Response to treatment according to YGTSS-R-TTS responder criterion, defined as a percent reduction in YGTSS-R-TTS of at least 30%, 35% and 50% (compared to baseline) The Global Severity Score has a range of 0- 100. A higher score on the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.

Time frame
Week 12 of each treatment period (visit 8 and 15).
3

Absolute change from baseline of YGTSS-R Total Score

Absolute change from baseline of YGTSS-R Total Score, the corresponding subdomain motor and phonic total tic scores, the YGTSS-R Impairment Score, as well as of the combination of the total tic score and the impairment score (YGTSS-R-GS (= YGTSS-R-TTS + YGTSS-R-impairment score).

Time frame
At baseline and 12 weeks after start of treatment in both arms.
4

Percent change from baseline of YGTSS-R Total Score

Percent change from baseline of YGTSS-R Total Score, the corresponding subdomain motor and phonic total tic scores, the YGTSS-R Impairment Score, as well as of the combination of the total tic score and the impairment score (YGTSS-R-GS (= YGTSS-R-TTS + YGTSS-R-impairment score).

Time frame
At baseline and 12 weeks after start of treatment in both arms.

Other outcomes

1

Number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs

Number of adverse events (AEs), number and rate of patients affected by AEs, Serious Adverse Events (SAE), Suspected Unexpected Serious Adverse reactions (SUSAR) /Adverse Drug Reaction (ADR), Adverse Events of Special Interest (AESI) and AEs leading to withdrawal at each visit.

Time frame
24 weeks
2

Absolute values of vital sign blood pressure at each visit and change from baseline.

Absolute values of vital sign blood pressure at each visit and change from baseline for each visit. Number and percentage of clinically significant abnormal values.

Time frame
24 weeks
3

Absolute values of vital sign heart rate at each visit and change from baseline.

Absolute values of vital sign heart rate at each visit and change from baseline for each visit. Number and percentage of clinically significant abnormal values.

Time frame
24 weeks
4

2.3. Suicide risk assessment measured by the Columbia-Suicide Severity Rating Scale (CSSRS)

Suicide risk assessment measured by the Columbia-Suicide Severity Rating Scale (CSSRS) and change from baseline for each on-site visit.

Time frame
Through out the study

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neurothera Labs Inc.

Lead sponsor

Source ClinicalTrials.gov

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