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Stiripentol

Clinical trials are studying Stiripentol in people age 6 years and older with primary hyperoxaluria types 1, 2, and 3. These studies are looking at whether it can help lower urinary oxalate and how safe it is in this patient group. The main trial is a Phase 3 study.

Table of Contents

Trial overview

The available trial is an interventional study, which means researchers give a study treatment and compare results with a control group.[1] It is studying Stiripentol in people with primary hyperoxaluria, including PH1, PH2, and PH3.[1]

The study title says it is evaluating the efficacy and safety of Stiripentol in patients 6 years and older with primary hyperoxaluria type 1, 2, or 3.[1] The study is authorised and planned for 42 participants.[1]

Who can participate

This trial is for patients who are at least 6 years old and have primary hyperoxaluria type 1, type 2, or type 3.[1] The trial data do not list other entry rules, so the main known target group is children, teens, and adults in this age range with these conditions.[1]

What the study measures

The main endpoint is the percent change in 24-hour urinary oxalate excretion corrected for body surface area from baseline to Month 6.[1] In simple terms, the study checks whether the amount of oxalate in urine changes after treatment over 6 months.[1]

Oxalate is measured in a full-day urine sample, which helps show how much of this substance the body is passing out.[1] The correction for body surface area helps adjust the result for differences in body size.[1]

Treatment and comparison groups

The trial includes Stiripentol given as Diacomit 250 mg hard capsules and Diacomit 500 mg hard capsules.[1] The listed dose in the trial data is 3000 mg by oral use.[1]

The study also uses a matched placebo, which is a look-alike capsule with no active ingredient.[1] Using a placebo helps researchers compare the study treatment with a control group in a fair way.[1]

Study design and phase

This is a Phase 3 trial.[1] Phase 3 studies are later-stage trials that usually involve more participants and focus on whether a treatment works and how safe it is in the target group.[1]

The study status is Authorised, which means it has been approved to take place.[1] The planned enrollment is 42 people.[1]

What this means for patients

For patients and families, this trial is mainly about whether Stiripentol can help lower urinary oxalate in primary hyperoxaluria.[1] The study is not broad; it is focused on people with specific subtypes of the disease and starts at age 6.[1]

Because the main endpoint is measured over 6 months, the trial is looking for a change over time rather than a quick short-term result.[1] The available data show a clear research aim, but they do not provide final results yet.[1]

Trial ID Phase Condition studied Status Enrollment
2023-508062-15-00 Phase 3 Primary Hyperoxaluria (PH1, PH2, PH3) Authorised 42

FAQ

  • What is being studied in Stiripentol clinical trials? The trial is studying whether Stiripentol can reduce urinary oxalate in people with primary hyperoxaluria. It also looks at safety.
  • Who can join the main Stiripentol trial? The trial includes patients 6 years and older with primary hyperoxaluria type 1, 2, or 3. The study is designed for this specific group.
  • What phase is the Stiripentol trial? The study is in Phase 3. This means it is a later-stage trial that helps test how well the treatment works and how safe it is.
  • What condition is this trial for? The trial is for primary hyperoxaluria, including all subtypes: PH1, PH2, and PH3. This is the condition listed in the study data.
  • What main result is the trial measuring? The main result is the percent change in 24-hour urinary oxalate excretion corrected for body surface area from the start of the study to Month 6. In simple terms, it measures how much oxalate leaves the body in urine over time.

Ongoing Clinical Trials on Stiripentol

  • Study on Stiripentol for Patients Aged 6 and Older with Primary Hyperoxaluria Types 1, 2, or 3

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy

Glossary

  • Primary hyperoxaluria: A rare condition in which the body makes too much oxalate, which can build up and be measured in urine.
  • PH1, PH2, PH3: The three subtypes of primary hyperoxaluria named in the trial. The study includes all of them.
  • Phase 3: A later stage of clinical research that tests how well a treatment works and checks safety in a larger group.
  • Interventional study: A trial where participants receive a study treatment or placebo so researchers can compare results.
  • Placebo: A look-alike treatment with no active ingredient. It helps researchers compare the study drug with a control group.
  • Matched placebo: A placebo made to look like the study capsules so the comparison is fair.
  • Urinary oxalate excretion: The amount of oxalate passed out in urine. The trial measures whether this amount changes over time.
  • 24-hour urine collection: A test that measures substances in all urine passed over one full day.
  • Body surface area (BSA): A body size measure used to adjust some test results so they are easier to compare between patients.
  • Enrollment: The number of people planned or included in the study.
  • Authorised: The study has been approved to take place.

References

  1. https://clinicaltrials.gov/study/2023-508062-15-00