Efficacy and Safety of Gemlapodect in Adults and Adolescents With Tourette Syndrome

Tourette Syndrome Clinical Trial

— Allevia2  

Official title:

A Double-blind, Placebo-controlled, Phase 2b, Multi-center, Twelve-week Prospective Study to Evaluate the Efficacy and Safety of Gemlapodect in Adult and Adolescent Patients With Tourette Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315751
• Other study ID #: NOE-TTS-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 31, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Noema Pharma AG
• Contact: Noema Pharma
• Phone: please contact via email
• Email: clinicaltrials[@]noemapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS. Adolescents will be enrolled after a sentinel cohort of adults is complete.

Description:

Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with Tourette Syndrome (TS). This is a multi-center, double-blind, parallel-arm, placebo-controlled study in patients with TS. Following screening to confirm eligibility and to wash-out previous TS medication during a 14-day placebo run-in, patients will be randomized 1:1 on Day 1 to receive gemlapodect or placebo once daily for 12 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Initially, patients aged 18 years onwards, at the time of signing the ICF form. Adolescents aged 12 years and older at the time of signing the ICF/informed assent form will be eligible for inclusion after completion of a sentinel cohort of adults

2. Moderate to severe Tourette Syndrome as defined by DSM-5 diagnostic criteria and TS-CGI-S = 4.

3. Treatment naive or previously treated patients in need of treatment alternative as per investigators judgement.

4. Patients must discontinue all medications used to treat TS for at least 14 days prior to randomization. Other psychotropic drugs, including stimulants, will be allowed provided they have been stable for at least 30 days prior to randomization and are expected to remain stable for the duration of the study.

5. BMI within the range 18 to 35 kg/m2 (inclusive).

6. Women of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

7. Capable of giving signed informed consent or consent from their legal representative.

8. Fluency in the language of the investigator, study staff, and the ICF/informed assent form when applicable.

Exclusion Criteria:

1. Any medical condition which, in the opinion of the investigator, could interfere with study procedures including but not limited to functional tic-like disorder, secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, malignant TS, neuroacanthocytosis, mental retardation as defined by the investigator, and autism.

2. Current diagnosis of severe anxiety, bipolar disorder, schizophrenia, or major depressive disorder (MDD). Patients with MDD on selective serotonin reuptake inhibitors treatment stable for greater than or equal to 1 month can participate in the study.

3. A history of severe traumatic brain injury or stroke.

4. Any unstable medical conditions, severe symptoms, or clinically significant abnormalities on screening test/examinations, including uncontrolled seizure disorders, which, in the investigator's judgment, will put them at a risk of major AE during this trial, or will interfere with safety and efficacy assessments.

5. Are undergoing active CBT (including but not limited to comprehensive behavioral intervention for tics, exposure and response prevention, relaxation training) during the last 28 days before the planned date of randomization and until the end of the trial. Patients willing to discontinue their CBT over this period are eligible to the study.

6. Known DSM-5 diagnosis of substance abuse or dependence.

7. Active suicidal ideation or behavior, as assessed by the C-SSRS

8. Use of prescribed or recreational cannabinoids during the study are prohibited. Prescribed cannabinoids include Epidiolex® (cannabidiol), Marinol® /Syndros® (dronabinol), and Cesamet® (nabilone). These medications will be discontinued during the Screening period. Recreational cannabinoids, regardless of their form of intake, which include tetrahydrocannabinol and/or cannabidiol, are prohibited.

9. Strong inhibitors of CYP3A4 are prohibited; commonly used strong inhibitors of CYP3A4 are limited to systemic oral antibiotics (e.g., clarithromycin, telithromycin), systemic, oral antifungals (eg, itraconazole, ketoconazole), and antivirals (eg, atazanavir, darunavir, indinavir).

10. Neurostimulation/deep brain stimulation for TS.

11. Participation in another clinical study with a study intervention administered in the last 30 days.

12. Patients with a known hypersensitivity to gemlapodect or any of the excipients of the product

13. Positive urine drug screen for cannabis, cocaine, or nonprescribed opiates.

14. The person is an employee or family member of an employee of the Sponsor, Investigator, or study site personnel..

15. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

16. Previous randomization in the present study.

17. The person is currently committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• Gemlapodect
Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with TS. Administered in the form of oral capsules.
• Placebo
Administered in the form of oral capsules with inert ingredients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Noema Pharma AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R)	YGTSS-R is a clinician rated score that evaluates number, frequency, intensity, complexity and interference of motor and phonic tics with a total score ranging from 0 to 50, with 50 being the most severe and 0 being no tics. Change in YGTSS-R total tic scores from baseline (randomization) to D85 for gemlapodect as compared to placebo.; The primary estimand is the difference in means between gemlapodect and placebo for the change in the TTS of the YGTSS-R from baseline (randomization) to D85, in the target patient population of adult and adolescent patients with TS, regardless of whether or not dose reduction, suspension, or treatment discontinuation occurred due to events attributable to treatment, and regardless of change in background medication (dose and product) while under treatment, but in the absence of any new treatment started after discontinuation of investigational intervention	85 days
Secondary	Impact on patient functioning	Change in Sheehan Disability Scale from baseline (randomization) to D85 for gemlapodect as compared to placebo	85 days
Secondary	Change in PUTS	Change in premonitory urge for tics scale from baseline (randomization) to D85 for gemlapodect as compared to placebo	85 days
Secondary	Safety and Tolerability of gemlapodect	The Incidence and severity of adverse events, including serious adverse events and adverse events of special interest	85 days
Secondary	Assessment of suicidality and suicidal ideation	Change in Columbia suicide severity rating scale (C-SSRS) subscale from baseline(randomization) to D85 for gemlapodect as compared to placebo. The C-SSRS supports suicide risk assessment through a series of simple, plain-language questions to assesses suicidal ideation and suicidal behavior.	85 days