Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is being measured
- Placebo comparison
- Key points for patients
Trial overview
The available study is an interventional trial, which means the research team gives a treatment and then watches what happens.[1] It is titled “Evaluation of the safety, tolerability, and effectiveness of CTH120 in adult males with Fragile X syndrome.”[1] The condition being studied is Fragile X syndrome.[1]
This trial is authorised and plans to enroll 30 participants.[1] The study brief says the goal is to assess the safety and tolerability of CTH120 compared with placebo.[1]
Who can participate
The target population is adult males with Fragile X syndrome.[1] No other inclusion details are provided in the source data, so the main known eligibility point is sex, age group, and diagnosis.[1]
Because the study is focused on a specific group, the results may apply most directly to men who match this profile.[1]
Study design and phase
The trial is in Phase 2.[1] Phase 2 studies usually look more closely at safety and early signs that a treatment may help, after earlier testing has already been done.[1]
The intervention includes 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE given orally as a 150 mg dose, and a matching placebo in hard capsules.[1] The placebo is made to look the same as the study medicine, so comparisons are fair.[1]
What is being measured
The main outcome is treatment-emergent adverse events, also called TEAEs, from Day 1 to the end of study.[1] These are health problems that appear after treatment starts or get worse during the study.[1]
The study also measures potentially clinically significant abnormalities, or PSCAs, in vital signs, 12-lead ECG, and safety laboratory parameters from Day 1 to the end of study.[1] In simple terms, the team checks whether the treatment is linked to important changes in blood pressure, heart tracing, or lab tests.[1]
Placebo comparison
The study compares 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE with a matching placebo.[1] A placebo contains the same inactive ingredients and looks the same as the investigational capsules, but it does not contain the study drug.[1]
This type of comparison helps researchers see whether any changes are more likely linked to the study treatment rather than to chance or to the study setting itself.[1]
Key points for patients
The trial is focused on a very specific group: adult males with Fragile X syndrome.[1]
It is a Phase 2 study, so it is designed to learn more about safety and early benefit signals.[1]
The main safety checks include side effects, vital signs, ECG results, and laboratory tests.[1]
Thirty people are planned to take part, which is a relatively small study size.[1]
The study uses a placebo comparison to help make the results clearer.[1]
