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Sodium Phosphate

Clinical trials investigating Sodium Phosphate are being used as part of a study in people with Angelman Syndrome. The trial looks at long-term safety and efficacy in a Phase 3 setting and follows patients over time. It mainly includes people with Angelman Syndrome who are receiving intrathecal treatment in the study.

Table of Contents

Trial overview

The clinical trial data shows one authorised study investigating Sodium Phosphate in people with Angelman Syndrome.[1] The study is described as a long-term extension trial, which means it continues research over a longer period after earlier study work.[1]

The brief summary says the trial aims to evaluate the long-term safety profile of GTX-102 in subjects with Angelman Syndrome.[1] The study also includes efficacy, meaning it looks at how well the treatment works over time.[1]

Study design and phase

This is an interventional study, which means researchers give study treatment and then observe the results.[1] The trial is in Phase 3, a later stage of clinical testing that usually includes more patients and focuses on safety and outcomes in a larger group.[1]

The study status is Authorised, and the planned enrollment is 98 participants.[1] This gives a sense of the trial size and that it is open for the research process described in the source data.[1]

Who can participate

The target population is patients with Angelman Syndrome.[1] The trial description does not list broader groups, so the study is focused on this specific condition.[1]

The intervention list includes study products given by intrathecal use, which means they are delivered into the space around the spinal cord.[1] The listed products are GTX-102, GTX/UX Diluent and Flush Solution, and ELLIOTTS B SOLUTION.[1]

What is being measured

The main endpoint is treatment-emergent adverse events and serious adverse events, including their frequency, severity, and relationship to the investigational product throughout the study.[1] In simple terms, the researchers want to know what medical problems happen after treatment starts, how serious they are, and whether they may be linked to the study treatment.[1]

This endpoint is important because it helps show the long-term safety profile of the treatment under study.[1] The source also states that the study is evaluating efficacy, but it does not give a detailed list of secondary outcomes in the trial data provided.[1]

Study treatments

The intervention section lists GTX-102, which is the investigational product named in the trial summary.[1] It also lists GTX/UX Diluent and Flush Solution and ELLIOTTS B SOLUTION as intrathecal study-related products.[1]

The source data does not provide a broader treatment comparison or placebo description, so the key point is that the study is following patients receiving these trial products as part of the research plan.[1]

Patient-friendly terms

Long-term extension trial means the study continues for a longer time so researchers can learn more about safety and results over time.[1] Efficacy means how well the treatment works for the condition being studied.[1]

Safety profile means the overall pattern of side effects or medical problems seen in the study.[1] Frequency means how often an event happens, and severity means how serious it is.[1]

Relationship to the investigational product means researchers judge whether a medical event may be caused by the study treatment.[1] These terms help patients understand what the trial team is watching during the study.[1]

Trial ID Phase Condition studied Status Enrollment
2024-510917-14-00 Phase 3 Angelman Syndrome Authorised 98

FAQ

  • What clinical trial is listed for Sodium Phosphate? The data shows one authorised Phase 3 interventional trial in people with Angelman Syndrome. It is a long-term extension study looking at safety and efficacy.
  • Who can take part in the trial? The target population is patients with Angelman Syndrome. The trial is designed for people already involved in the study treatment plan.
  • What is the main goal of the trial? The main goal is to evaluate long-term safety and efficacy. The study especially tracks treatment-emergent adverse events and serious adverse events.
  • What phase is the trial in? The trial is in Phase 3. This phase usually means the study is testing treatment in a larger group of patients and collecting more detailed safety and outcome data.
  • What outcomes are being measured? The primary outcome is the frequency, severity, and relationship of treatment-emergent adverse events and serious adverse events to the investigational product. This helps researchers understand how the study treatment is tolerated over time.

Ongoing Clinical Trials on Sodium Phosphate

  • Study on the Long-Term Safety of GTX-102 for Patients with Angelman Syndrome

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

Glossary

  • Angelman Syndrome: A condition studied in the trial. The trial is focused on patients who have this diagnosis.
  • Phase 3: A later stage of clinical research where a treatment is studied in a larger group to learn more about safety and results.
  • Interventional study: A type of trial where researchers give a treatment or study product and observe what happens.
  • Long-term extension trial: A study that continues after an earlier trial so researchers can follow patients for a longer time.
  • Safety: How well a treatment is tolerated and whether it causes unwanted medical problems.
  • Efficacy: How well a treatment works for the condition being studied.
  • Treatment-emergent adverse events: Medical problems that start or get worse after treatment begins.
  • Serious adverse events: Severe medical problems that may need urgent care, hospital treatment, or may be life-threatening.
  • Intrathecal use: Given into the space around the spinal cord. This is a special route used in some studies.
  • Investigational product: The study treatment being tested in the trial.

References