A Phase IIb Study to Determine the Safety, Tolerability and Efficacy of a Daily Oral Dose of SCI-110 in Adult Patients with Tourette's Syndrome (TS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Neurothera Labs Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

26 Mar 2026 → ongoing

Decision date (initial)

2024-07-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Neurothera Labs Inc.

External identifiers

EU CT number

2024-512949-17-00

EudraCT number

2021-001513-37

WHO UTN

U1111-1312-0090

ClinicalTrials.gov

NCT05126888

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Dose response, Therapy

Primary efficacy objective:
[CCI]

Secondary objectives 7

1. [CCI]
2. [CCI]
3. [CCI]
4. [CCI]
5. [CCI]
6. To proof safety of SCI-110 in adult patients with TS through the assessment of Adverse Events (AE), Serious Adverse Events (SAE), Serious Unexpected Adverse Reactions (SUSARs)/ Adverse Drug Reactions (ADRs) and discontinuations due to AE.
7. To assure acceptable tolerability via measurement of normal body functions (vital signs).

Conditions and MedDRA coding

Tourette's syndrome in adults (≥18 and ≤65 years) in out-patient care

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. TS according to DSM-5
2. Male and female subjects with an age between ≥18 and ≤65 years
3. Total tic score (TTS) of the YGTSS-R >14
4. CGI-S ≥4
5. Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study
6. Signed written informed consent and willingness to comply with treatment and follow-up procedures
7. Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study
8. Women of child-bearing potential must have a negative pregnancy test (e.g., urine human chorionic gonadotropin [HCG]) before first treatment with study medication. They must practice a highly effective, reliable and medically approved contraceptive regimen during the study (e.g., theoretical failure rate less than 1% per year a when used consistently and correctly), which include oral or parenteral or implanted hormonal contraception, vaginal ring releasing hormonal contraception (e.g., Nuvaring), intrauterine device or intrauterine system. Women without childbearing potential may enter this study.
9. Male subjects must be willing to use a condom with sexual partners during this study and for a period of three months following the last administration of study medication until the follow-up visit. Male subjects must be willing to abstain from sperm donation for 3 months after the completion of this study.

Exclusion criteria 18

1. Comorbid OCD, ADHD, depression, and anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
2. Ongoing behavioural treatment for tics
3. History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder
4. Current clinical diagnosis of substance abuse or dependence
5. History of or current cannabis dependence
6. Secondary and other chronic tic disorders or other significant neurological disorders
7. Known severe cardiac diseases, known severe cardiovascular diseases, known positive for human immunodeficiency virus (HIV), known hepatitis C, known hepatitis B, or other severe hepatic and renal disorders by history
8. Concomitant medications have to be on stable dose since at least 6 weeks before entering the study and must be well tolerated at baseline without causing dizziness, confusion, sedation, or somnolence such as central nervous system depressants (e.g., antipsychotics, barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants)
9. Subjects with active suicidal ideation and behaviour (SI/B) according to the Columbia-Suicide Severity Rating Scale (C-SSRS) and/or subjects that have attempted suicide in the past.
10. Use of cannabis or CBM in the 30-day period prior to study entry and/or positive delta-9-THC urine test at baseline
11. Positive urine beta-hCG pregnancy test
12. Pregnant or breast-feeding women
13. Subjects who received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug or to use an investigational device during the course of the study
14. Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and excipients of study medication (e.g., cannabis, cannabinoids, etc.)
15. Any condition, which in the opinion of the investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
16. Subjects who are employees of the sponsor or employees or close relatives of the investigator
17. Presence of comorbid psychiatric conditions: developmental disability, psychotic illness and bipolar disorder
18. Subjects who suffer from Cirrhosis of the Liver based on the Child-Pugh Scoring System (Child A to C)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. [CCI]

Secondary endpoints 9

1. [CCI]
2. [CCI]
3. [CCI]
4. [CCI]
5. [CCI]
6. [CCI]
7. [CCI]
8. Number of adverse events (AEs), number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs leading to withdrawal at each visit.
9. Absolute values of vital signs (blood pressure, heart rate) at each visit and change from baseline for each visit. Number and percentage of clinically significant abnormal values.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Neurothera Labs Inc.

Sponsor organisation

Neurothera Labs Inc.

Address

Suite 600-890 West Pender Street

City

Vancouver

Postcode

V6C 1J9

Country

Canada

Scientific contact point

Organisation

Neurothera Labs Inc.

Contact name

Clinical trials division

Public contact point

Organisation

Neurothera Labs Inc.

Contact name

Clinical trials division

Third parties 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications