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2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE

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.

Table of Contents

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]

Trial ID Phase Condition studied Status Enrollment
2025-522972-97-00 Phase 2 Fragile X syndrome Authorised 30

FAQ

  • What is being studied in these trials? The trial is studying 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE, also called CTH120 in the title. It is being compared with a matching placebo to see how safe and effective it is.
  • Who can take part in the trial? The study is for adult males with Fragile X syndrome. Other details about who can join are not provided in the trial data.
  • What phase is the trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and continue checking safety.
  • What condition is the trial focused on? The trial focuses on Fragile X syndrome. This is the condition listed in the study record.
  • What safety measures are being checked? The study measures treatment-emergent adverse events, which are health problems that appear or get worse after treatment starts. It also checks vital signs, ECG results, and safety laboratory tests for clinically important changes.

Ongoing Clinical Trials on 2-[4-[3-(METHYLAMINO)-1-PHENYLPROPOXY]PHENYL]ETHANOL HYDROCHLORIDE

  • Testing the Safety and Effectiveness of CTH120 Compared to Placebo in Adult Men with Fragile X Syndrome

    Recruiting

    1
    Investigated drugs:
    Spain

Glossary

  • Fragile X syndrome: The condition being studied in this trial. The trial data do not give a full description of the disease.
  • Adult males: Men who are old enough to take part in an adult study. This is the target group for the trial.
  • Phase 2: A study stage that looks more closely at whether a treatment may help and continues to check safety.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Interventional study: A study where researchers give a treatment and then measure the effects.
  • Safety: How well a treatment is tolerated and whether it causes unwanted health problems.
  • Tolerability: How well people can take a treatment without major problems.
  • Effectiveness: How well the treatment works in the study setting.
  • Treatment-emergent adverse events: Health problems that start or become worse after the study treatment begins.
  • Vital signs: Basic body measurements such as pulse and blood pressure that help show general health.
  • ECG: A heart test that records the electrical activity of the heart.
  • Safety laboratory parameters: Blood or other lab test results used to check for safety problems.