Tourette SyndromePhase 2ALLEVIA2NCT06315751
Efficacy and Safety of Gemlapodect (NOE-105) in Adults and Adolescents With Tourette Syndrome
A Phase 2 study testing Gemlapodect in people with Tourette Syndrome, run by Noema Pharma AG at 46 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Gemlapodect
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 46 sitesin 7 countries
- Study dates
- 10 Sep 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Moderate to severe Tourette Syndrome as defined by DSM-5 diagnostic criteria and TS-CGI-S ≥ 4.
- Treatment naive or previously treated patients in need of treatment alternative as per investigators judgement.
- 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.
- Capable of giving signed informed consent or consent from their legal representative.
- Fluency in the language of the investigator, study staff, and the ICF/informed assent form when applicable.
Who cannot join
- 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, autism, and history of known intellectual disability that would affect patient's ability to comply with study procedures.
- Current active diagnosis of severe anxiety, bipolar disorder, schizophrenia, major depressive disorder (MDD,), or Parkinson's disease. Patients with a history of MDD on selective serotonin reuptake inhibitors treatment stable for at least a month may participate in the study.
- 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.
- 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.
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- Active suicidal ideation or behavior.
- 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 are prohibited during the study.
- Neurostimulation/deep brain stimulation for TS.
- Participation in another clinical study with a study intervention administered in the last 30 days.
- 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.
- The person is currently committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Trial locations and contacts
46 sites in 7 countries.
46 sites in 7 countries
United States31 sites
Noema TTS-201 Site #51
Ann Arbor, Michigan, 48105
Noema TTS-201 Site #79
Atlanta, Georgia, 30318
Noema TTS-201 Site #50
Bellevue, Washington, 98007
Noema TTS-201 Site #95
Bellflower, California, 90706
Noema TTS-201 Site #55
Boston, Massachusetts, 02114
Noema TTS-201 Site #57
Charlotte, North Carolina, 28211
Noema TTS-201 Site #42
Dallas, Texas, 75243
Noema TTS-201 Site #22
Fort Worth, Texas, 76104
Noema TTS-201 Site #75
Glendale, California, 91203
Noema TTS-201 Site #54
Gulf Breeze, Florida, 32561
Noema TTS-201 Site #05
Hialeah, Florida, 33013
Noema TTS-201 Site #97
Jensen Beach, Florida, 34957
Noema TTS-201 Site #71
Largo, Florida, 33777
Noema TTS-201 Site #93
Lincoln, Nebraska, 68526
Noema TTS-201 Site #44
Maitland, Florida, 32751
Noema TTS-201 Site # 74
Miami, Florida, 33136
Noema TTS-201 Site #56
Miami Lakes, Florida, 33016
Noema TTS-201 Site #58
Middleburg Heights, Ohio, 44130
Noema TTS-201 Site #98
Nashville, Tennessee, 37203
NOema TTS-201 Site #19
New York, New York, 10003
Noema TTS-201 Site #73
North Charleston, South Carolina, 29405
Noema TTS-201 Site #45
Orem, Utah, 84097
Noema TTS-201 Site #61
Orlando, Florida, 32802
Noema TTS-201 Site #87
Peachtree Corners, Georgia, 30071
Noema TTS-201 Site #18
Petersburg, Virginia, 23805
Noema TTS-201 Site #96
Saint Charles, Missouri, 63304
Noema TTS-201 Site #94
San Antonio, Texas, 78249
Noema TTS-201 Site #59
San Rafael, California, 94903
Noema TTS-201 Site #03
Stony Brook, New York, 11794
Noema TTS-201 Site #81
Sun City, Arizona, 85351
Noema TTS-201 Site #21
Walnut Creek, California, 94596
Spain6 sites
Noema TTS-201 Site #26
Barcelona, 08041
Noema TTS-201 Site #15
Burgos, 09006
Noema TTS-201 Site #27
Madrid, 28922
Noema TTS-201 Site #17
Oviedo, 33011
Noema TTS-201 Site #16
Sant Cugat del Vallès, 08190
NOE-TTS-201 Site #28
Seville, 41013
Germany3 sites
Noema TTS-201 Site #35
Düsseldorf, 40225
Noema TTS-201 Site #09
Hanover, 30625
NOE-TTS-201 Site #25
Munich, 80336
France2 sites
Noema TTS-201 #07
Bron, 69677
Noema TTS-201 Site #08
Poitiers, 86000
Poland2 sites
Noema TTS-201 Site #13
Katowice, 40097
Noema TTS-201 Site #14
Katowice, 40123
About this study
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
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.
Read the detailed 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. See https://allevia2study.com
- Conditions
- Tourette Syndrome
- Being tested
- Gemlapodect, Placebo
- Keywords
- NOE-105
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemlapodectDrug
Also called NOE-105
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.
PlaceboDrug
Administered in the form of oral capsules with inert ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Gemlapodect | Experimental | Escalating doses of NOE-105 capsules Receives: Drug: Gemlapodect |
| Placebo | Placebo comparator | Escalating doses of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 85 days
Secondary outcomes (4)
Impact on patient functioning
Change in Sheehan Disability Scale from baseline (randomization) to D85 for gemlapodect as compared to placebo
Measured: 85 days
Change in PUTS
Change in premonitory urge for tics scale from baseline (randomization) to D85 for gemlapodect as compared to placebo
Measured: 85 days
Safety and Tolerability of gemlapodect
The Incidence and severity of adverse events, including serious adverse events and adverse events of special interest
Measured: 85 days
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.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start10 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noema Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Director, MD, Study director, Noema Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315751
- Sponsor's protocol ID
- NOE-TTS-201
- Acronym
- ALLEVIA2
- Status last verified
- May 2025
- First submitted
- 6 Dec 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06315751
- Acronym / sponsor ID
- ALLEVIA2 / NOE-TTS-201
- Conditions
- Tourette Syndrome
- Keywords
- NOE-105
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Noema Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. See https://allevia2study.com
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemlapodect | Experimental | Drug: GemlapodectEscalating doses of NOE-105 capsules |
| Placebo | Placebo comparator | Drug: PlaceboEscalating doses of matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Moderate to severe Tourette Syndrome as defined by DSM-5 diagnostic criteria and TS-CGI-S ≥ 4.
- Treatment naive or previously treated patients in need of treatment alternative as per investigators judgement.
- 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).
Key exclusion criteria (17 listed)
- 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, autism, and history of known intellectual disability that would affect patient's ability to comply with study procedures.
- Current active diagnosis of severe anxiety, bipolar disorder, schizophrenia, major depressive disorder (MDD,), or Parkinson's disease. Patients with a history of MDD on selective serotonin reuptake inhibitors treatment stable for at least a month may participate in the study.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemlapodectAlso: NOE-105Gemlapodect 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. | Drug | Gemlapodect |
| PlaceboAdministered in the form of oral capsules with inert ingredients. | Drug | Placebo |
Primary outcome
Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R)
Time frame: 85 days
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
4 secondary outcomes
Impact on patient functioning
Time frame: 85 days
Change in PUTS
Time frame: 85 days
Safety and Tolerability of gemlapodect
Time frame: 85 days
Assessment of suicidality and suicidal ideation
Time frame: 85 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tourette Syndrome
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Director, MD study director
Noema Pharma AG
46 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemlapodect in people with Tourette Syndrome, run by Noema Pharma AG at 46 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Spain, Germany, France, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R) (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.