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)
- Conditions
- Tourette's syndrome in adults (≥18 and ≤65 years) in out-patient care
- Registration Number
- 2024-512949-17-00
- Lead Sponsor
- Scisparc Ltd.
- Brief Summary
Primary efficacy objective:
[CCI]
- Detailed Description
It is believed that SCI-110 will be a valuable treatment option, especially for t those subjects with TS, who do not benefit from or do not tolerate first-line treatment with antipsychotics. Since there is evidence that currently available CBM improves not only tics, but also psychiatric comorbidities, SCI-110 might be even more beneficial to improve a broader spectrum of symptoms resulting in both improved quality of life and decreased disease related costs. Moreover, PEA was shown to minimize AEs associated with cannabinoids use and to reduce their required effective dose (data not published). Hence, the use of SCI-110 is expected to show a therapeutic effect superior to currently available CBMs.
It can be assumed that AEs in TS subjects do not differ from AEs described in other groups of subjects treated with medicinal cannabis and/or cannabinoids. In general, cannabinoids are considered as well tolerated.
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 56
TS according to DSM-5
Male and female subjects with an age between ≥18 and ≤65 years
Total tic score (TTS) of the YGTSS-R >14
CGI-S ≥4
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
Signed written informed consent and willingness to comply with treatment and follow-up procedures
Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study
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.
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.
Comorbid OCD, ADHD, depression, and anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
Use of cannabis or CBM in the 30-day period prior to study entry and/or positive delta-9-THC urine test at baseline
Positive urine beta-hCG pregnancy test
Pregnant or breast-feeding women
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
Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and excipients of study medication (e.g., cannabis, cannabinoids, etc.)
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
Subjects who are employees of the sponsor or employees or close relatives of the investigator
Presence of comorbid psychiatric conditions: developmental disability, psychotic illness and bipolar disorder
Subjects who suffer from Cirrhosis of the Liver based on the Child-Pugh Scoring System (Child A to C)
Ongoing behavioural treatment for tics
History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder
Current clinical diagnosis of substance abuse or dependence
History of or current cannabis dependence
Secondary and other chronic tic disorders or other significant neurological disorders
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
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)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method [CCI] [CCI]
- Secondary Outcome Measures
Name Time Method [CCI] [CCI]
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. 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.
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. 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.
Trial Locations
- Locations (1)
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Medizinische Hochschule Hannover🇩🇪Hanover, GermanyKirsten Müller-VahlSite contact+495115323551mueller-vahl.kirsten@mh-hannover.de