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A Double-blind, Placebo-controlled, Phase IIb, Multi-center, Twelve-week Prospective Study to Evaluate the Efficacy and Safety of Gemlapodect in Adult and Adolescent Patients with Tourette Syndrome – Allevia 2
EU CTIS ID: 2023-505086-83-00
What this study is testing
Change in tic severity score YGTSS-R
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 18 years onwards, at the time of signing the ICF/informed assent form. Patients from 12 years to 17 years of age can be enrolled after regional regulatory approval for adolescent inclusion has been granted.
- Moderate to severe TS as defined by DSM-5 diagnostic criteria and TS-CGI-S ≥ 4
- Patient is treatment naive or previously treated patients in need of treatment alternative as per investigators judgemen
- 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
- BMI within the range 18 to 35 kg/m2 (inclusive)
- 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. Contraception should be used as described in Appendix 3 (Section 10.3) of the Protocol .A female patient prior to reaching childbearing potential will be allowed into the study according to the judgement of the investigator and in agreement with the medical monitor with regular reassessment of their status, including accepting the requirement for monthly pregnancy testing, including approximately 28 days following the cessation of study medication.
You likely can't join if
- 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 (defined as ≥2 emergency room visits or ≥1 hospitalization for TS symptoms or its associated behavioral comorbidities), neuroacanthocytosis, autism, and history of known intellectual disability that would affect patient’s ability to comply with study procedures).
- 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 enroll in the study.
- Known DSM-5 diagnosis of substance abuse or dependence
- Active suicidal ideation or behavior, as assessed by the answer “YES” to Items 4, or 5 on the C-SSRS Suicidal Ideation. Management of patients exhibiting such symptoms is described in Section 7.1.4.
- Neurostimulation/deep brain stimulation for TS
- Participation in another clinical study with a study intervention administered in the last 30 days
See the full eligibility criteria
Who can join
- Patients aged 18 years onwards, at the time of signing the ICF/informed assent form. Patients from 12 years to 17 years of age can be enrolled after regional regulatory approval for adolescent inclusion has been granted.
- Moderate to severe TS as defined by DSM-5 diagnostic criteria and TS-CGI-S ≥ 4
- Patient is treatment naive or previously treated patients in need of treatment alternative as per investigators judgemen
- 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
- BMI within the range 18 to 35 kg/m2 (inclusive)
- 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. Contraception should be used as described in Appendix 3 (Section 10.3) of the Protocol .A female patient prior to reaching childbearing potential will be allowed into the study according to the judgement of the investigator and in agreement with the medical monitor with regular reassessment of their status, including accepting the requirement for monthly pregnancy testing, including approximately 28 days following the cessation of study medication.
- Capable of giving signed informed consent or consent from their legal representative is obtained as described in Appendix 1 ((Section 10.1.3) of the Protocol which includes compliance with the requirements and restrictions listed in the ICF/informed assent form and in the protocol
- Fluency in the language of the investigator, study staff, and the ICF/informed assent form when applicable
What rules you out
- 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 (defined as ≥2 emergency room visits or ≥1 hospitalization for TS symptoms or its associated behavioral comorbidities), neuroacanthocytosis, autism, and history of known intellectual disability that would affect patient’s ability to comply with study procedures).
- 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 enroll in the study.
- Known DSM-5 diagnosis of substance abuse or dependence
- Active suicidal ideation or behavior, as assessed by the answer “YES” to Items 4, or 5 on the C-SSRS Suicidal Ideation. Management of patients exhibiting such symptoms is described in Section 7.1.4.
- Neurostimulation/deep brain stimulation for TS
- Participation in another clinical study with a study intervention administered in the last 30 days
- 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. Study participants prescribed cannabinoids for seizure disorders are not eligible for study participation. Recreational cannabinoids, regardless of their form of intake, which include tetrahydrocannabinol and/or cannabidiol, are prohibited.
- Strong inhibitors and inducers of CYP3A4 as well as strong inhibitors and inducers of CYP2C8 are prohibited during the study and will be discontinued during the screening period; See Section 6.10.2.
- The person is currently committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Patients with a known hypersensitivity to gemlapodect or any of the excipients of the product
- Positive urine drug screen for cannabis, cocaine, or nonprescribed opiates
- The person is an employee or family member of an employee of the Sponsor, Investigator, or study site personnel.
- 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
- Previous randomization in the present study
- Current active diagnosis of severe anxiety, bipolar disorder, schizophrenia, major depressive disorder (MDD), or Parkinson’s disease. Patients with a history of comorbid psychiatric conditions, including obsessive-compulsive disorder (OCD), attention-deficit/hyperactivity disorder (ADHD) and MDD, may participate in the study as long as their treatments have been stable for ≥ 1 month
- A history of severe traumatic brain injury or stroke
- 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. In particular, patients with moderate or severe hepatic impairment [Child Pugh class B (7-9 total points) or Child Pugh class C (10-15 total points)] and/or severe renal impairment (eGFR≤30 mL/min/1.73m2 ) are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.