Safety, Tolerability, and Preliminary Effectiveness of CTH120 in Fragile X Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-45
SponsorConnecta Therapeutics, S.L.
About this trial
The purpose of this Phase IIa study is to evaluate the safety, tolerability, and effectiveness of CTH120 in adult males with Fragile X syndrome.
Eligibility criteria
Qualifiers
Adult male participants.
Aged ≥ 18 and ≤ 45 years.
Weight ≥ 50 kg and ≤ 100 kg.
Body mass index (BMI) ≥ 18.5 and ≤ 32.
Disqualifiers
Personal history of infantile spasms/convulsions/epilepsy, severe head trauma or CNS infections (e.g. meningitis), except for infantile febrile seizures.
Participants with a current diagnosis of severe (Level 3) autism spectrum disorder or any primary psychiatric diagnosis according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-DSM-5). Diagnoses that are secondary, such as attention deficit hyperactivity disorder, depressive disorders, anxiety disorders and conduct disorders are allowed if they are considered to not interfere with study conduct and are stable during the 8 weeks prior to screening. Related allowed treatments must be on stable dosing for the last 3 months.
Substance use disorder according to the DSM-5 criteria.
Epileptiform abnormalities on EEG (excluding isolated sharp waves and beyond those expected for age).
Trial design
Treatments tested in this trial
- CTH120
- CTH120 placebo hard capsules
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Connecta Therapeutics, S.L.
Lead sponsor
Hospital del Mar Research Institute (IMIM)
Collaborator
Corporacion Parc Tauli
Collaborator
Ministry of Science and Innovation, Spain
Collaborator
Astrum CRO, S.L.
Collaborator
Source ClinicalTrials.gov