In short
Clinical trials are investigating 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE, also called CTH120 in the study title, in adult males with Fragile X syndrome. The trial is looking at safety, tolerability, and effectiveness compared with placebo. It is a Phase 2 study.
Key points
- Clinical trials are studying 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE in adult males with Fragile X syndrome. The available trial is a Phase 2 interventional study with 30 participants. It compares the study drug with a matching placebo to assess safety, tolerability, and effectiveness. The main outcomes include treatment-emergent adverse events and changes in vital signs, ECG results, and safety laboratory tests. The trial status is Authorised. The study title also names the substance as CTH120.
Trial overview
The available study is titled Evaluation of the safety, tolerability, and effectiveness of CTH120 in adult males with Fragile X syndrome.1 It is an interventional trial, which means researchers are giving a study treatment and then measuring the results.1
The study is testing 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE against a matching placebo.1 The trial record also uses the name CTH120 for the study treatment.1
Who can participate
This trial is for adult males with Fragile X syndrome.1 The source data do not list any other participation details, such as age limits beyond adulthood or other health requirements.1
What is being studied
The main goal is to assess the safety, tolerability, and effectiveness of CTH120 compared with placebo.1 Safety means whether unwanted health problems happen, tolerability means how well people can take the treatment, and effectiveness means whether the treatment appears to help in the study setting.
The trial is in Phase 2, which is a study stage that usually looks more closely at whether a treatment may work while continuing safety checks.1
Trial endpoints and safety checks
The primary outcomes are treatment-emergent adverse events from Day 1 to the end of study and potentially clinically significant abnormalities in vital signs, 12-lead ECG, and safety laboratory parameters from Day 1 to the end of study.1
Treatment-emergent adverse events are health problems that start or get worse after treatment begins.1 Vital signs are basic health measures such as pulse and blood pressure, ECG is a heart test, and laboratory parameters are test results from blood or other samples used to watch for safety changes.1
Trial status and design
The trial status is Authorised.1 The planned enrollment is 30 participants.1
The study compares an oral 150 mg dose of 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE with a matching placebo given as hard capsules.1 The placebo is described as having the same excipients and the same appearance as the study capsules.1
Key patient points
- The trial is focused on one condition only: Fragile X syndrome.1
- The target group is adult males, so the study is not listed for women or children in the source data.1
- The study is mainly about safety and tolerability, with effectiveness also being evaluated.1
- Researchers are watching for changes in symptoms, vital signs, heart rhythm by ECG, and lab test results.1