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

Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Noema TTS-201 Site #63
ACTIVE_NOT_RECRUITING
Dothan
Arizona
Noema TTS-201 Site #81
RECRUITING
Sun City
California
Noema TTS-201 Site #95
RECRUITING
Bellflower
Noema TTS-201 Site #75
RECRUITING
Glendale
Noema TTS-201 Site #59
RECRUITING
San Rafael
Noema TTS-201 Site #21
RECRUITING
Walnut Creek
Florida
Noema TTS-201 Site #54
RECRUITING
Gulf Breeze
Noema TTS-201 Site #05
RECRUITING
Hialeah
Noema TTS-201 Site #97
RECRUITING
Jensen Beach
Noema TTS-201 Site #71
RECRUITING
Largo
Noema TTS-201 Site #44
RECRUITING
Maitland
NOE-TTS-201 Site #62
WITHDRAWN
Miami
Noema TTS-201 Site #84
ACTIVE_NOT_RECRUITING
Orange City
Noema TTS-201 Site #61
RECRUITING
Orlando
Georgia
Noema TTS-201 Site #79
RECRUITING
Atlanta
Noema TTS-201 Site #87
RECRUITING
Peachtree Corners
Massachusetts
Noema TTS-201 Site #55
RECRUITING
Boston
Michigan
Noema TTS-201 Site #51
RECRUITING
Ann Arbor
Missouri
Noema TTS-201 Site #96
RECRUITING
Saint Charles
North Carolina
Noema TTS-201 Site #57
RECRUITING
Charlotte
Nebraska
Noema TTS-201 Site #93
RECRUITING
Lincoln
New York
Noema TTS-201 Site #82
ACTIVE_NOT_RECRUITING
New York
Noema TTS-201 Site #03
RECRUITING
Stony Brook
Ohio
Noema TTS-201 Site #58
RECRUITING
Middleburg Heights
South Carolina
Noema TTS-201 Site #73
RECRUITING
North Charleston
Tennessee
Noema TTS-201 Site #98
RECRUITING
Nashville
Texas
Noema TTS-201 Site #42
RECRUITING
Dallas
Noema TTS-201 Site #22
RECRUITING
Fort Worth
Noema TTS-201 Site #94
RECRUITING
San Antonio
Utah
Noema TTS-201 Site #45
RECRUITING
Orem
Virginia
Noema TTS-201 Site #18
RECRUITING
Petersburg
Other Locations
Belgium
Noema TTS-201 Site #06
COMPLETED
Ghent
France
Noema TTS-201 #07
RECRUITING
Bron
NOE-TTS-201 Site #32
RECRUITING
Lille
Noema TTS-201 Site #08
RECRUITING
Poitiers
Germany
Noema TTS-201 Site #35
RECRUITING
Düsseldorf
Noema TTS-201 Site #09
RECRUITING
Hanover
NOE-TTS-201 Site #25
RECRUITING
Munich
Hungary
Noema TTS-201 Site #11
COMPLETED
Budapest
Noema TTS-201 Site #30
COMPLETED
Budapest
Poland
Noema TTS-201 Site #24
COMPLETED
Gdansk
Noema TTS-201 Site #13
COMPLETED
Katowice
Noema TTS-201 Site #14
COMPLETED
Katowice
Noema TTS-201 Site #29
COMPLETED
Poznan
Spain
Noema TTS-201 Site #26
RECRUITING
Barcelona
Noema TTS-201 Site #15
RECRUITING
Burgos
Noema TTS-201 Site #27
RECRUITING
Madrid
Noema TTS-201 Site #17
RECRUITING
Oviedo
Noema TTS-201 Site #16
RECRUITING
Sant Cugat Del Vallès
NOE-TTS-201 Site #28
RECRUITING
Seville
Contact Information
Primary
Noema Pharma
clinicaltrials@noemapharma.com
please contact via email
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2026-04
Participants
Target number of participants: 180
Treatments
Experimental: Gemlapodect
Escalating doses of NOE-105 capsules
Placebo_comparator: Placebo
Escalating doses of matching placebo
Sponsors
Leads: Noema Pharma AG

This content was sourced from clinicaltrials.gov