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Valproate Semisodium

Clinical trials are investigating Valproate Semisodium in different patient groups, including older adults with severe epilepsy and people with low- to moderate-risk rectal cancer. These studies are looking at whether the treatment is effective and what outcomes it can improve in each condition. Some trials are also testing safety and the best treatment approach.

Table of Contents

Trials overview

The data include two interventional studies of Valproate Semisodium, also listed in one trial record as valproic acid. One study is in older adults with a seizure emergency, and the other is in people with rectal cancer before surgery.[1][2]

Both studies are authorised, but they are at different phases and measure different outcomes. This means the research is not about one single disease; it is testing the substance in separate clinical settings.[1][2]

Status epilepticus study in older adults

The first trial is a Phase 3 study called “Treatment of Established Status Epilepticus in the Elderly – a prospective, randomized, double-blind comparative effectiveness trial.” It studies people 65 years or older who have convulsive or nonconvulsive benzodiazepine-resistant established status epilepticus (eSE).[1]

This is a serious seizure emergency. In this trial, Valproate Semisodium is given by infusion and compared with levetiracetam, which is also given by infusion.[1]

The study is designed as a prospective, randomized, double-blind comparative effectiveness trial. Randomized means participants are assigned by chance, and double-blind means neither the patient nor the study team knows which treatment is being given during the study period.[1]

Rectal cancer study before surgery

The second trial is titled “VshoRT-R3: Phase 1/2 study of valproic acid and short-course radiotherapy plus capecitabine as preoperative treatment in low-moderate risk rectal cancer.” It studies people with low-risk rectal cancer, described in the source as low- risk rectal cancel, before radical surgery.[2]

This study uses oral Valproate Semisodium with capecitabine during short-course radiotherapy. The trial is looking at treatment given before surgery, which is called preoperative treatment.[2]

The study has two parts. In Phase 1, it aims to find the maximum tolerated dose, or MTD, for capecitabine alone or with valproic acid during short-course radiotherapy. In Phase 2, it explores whether adding valproic acid or adding capecitabine to short-course radiotherapy may improve tumor response before surgery.[2]

Outcomes and endpoints

In the epilepsy trial, the primary endpoint is whether intravenous Valproate Semisodium or levetiracetam can stop eSE and keep epileptic activity under control for up to 60 minutes after treatment starts.[1]

In the rectal cancer trial, the Phase 1 endpoint is the MTD, which helps researchers learn the highest dose that can be used in the study setting. The Phase 2 endpoint is TRG1, a measure of strong tumor regression, meaning the tumor responds very well to treatment.[2]

These endpoints show that the trials are asking different questions. One is focused on stopping seizures quickly, while the other is focused on dose finding and tumor response before surgery.[1][2]

Who may participate

The epilepsy study includes people who are 65 years or older and have convulsive or nonconvulsive benzodiazepine-resistant established status epilepticus.[1]

The rectal cancer study includes patients with low- to moderate-risk rectal cancer who are being treated before surgery.[2]

Because the studies target very different populations, a person could only be eligible for one of them if their medical condition matches the trial’s requirements.[1][2]

What these trials mean for patients

These studies show that Valproate Semisodium is being tested in both emergency neurology and cancer care. The research is not about routine use in general; it is about answering specific questions in carefully defined patient groups.[1][2]

In the seizure trial, the main goal is rapid control of established status epilepticus in older adults. In the cancer trial, the main goal is to see whether treatment before surgery can improve tumor response and help define a workable dose plan.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-516634-35-00 Phase 3 Convulsive or nonconvulsive benzodiazepine-resistant established status epilepticus in people 65 years or older Authorised 132
NCT01898104 Phase 1 / Phase 2 Low- to moderate-risk rectal cancer Authorised 120

FAQ

  • What conditions are being studied with Valproate Semisodium? The trials in this data are studying established status epilepticus in older adults and low- to moderate-risk rectal cancer. These are very different conditions, so the research questions are also different.
  • Who can take part in these trials? One trial includes people 65 years or older with benzodiazepine-resistant established status epilepticus. Another trial includes patients with low- to moderate-risk rectal cancer who are being treated before surgery.
  • What phases are the Valproate Semisodium trials in? The epilepsy trial is Phase 3. The rectal cancer study is a Phase 1 study with a Phase 2 part.
  • What is the main goal of the epilepsy trial? The main goal is to see whether intravenous Valproate Semisodium can stop established status epilepticus and keep it controlled for up to 60 minutes after treatment starts.
  • What is being measured in the rectal cancer trial? The study looks at the maximum tolerated dose, which means the highest dose that can be given safely, and the rate of pathologic complete tumor regression, called TRG1. TRG1 means the tumor shows a very strong response after treatment.

Ongoing Clinical Trials on Valproate Semisodium

  • Study of Valproic Acid, Capecitabine, and Radiotherapy for Patients with Low-Moderate Risk Rectal Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study on Treating Status Epilepticus in Seniors Using Levetiracetam and Valproate Semisodium

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, effective, or both.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 1: An early trial phase that often focuses on dose finding and safety.
  • Phase 2: A trial phase that looks more closely at whether a treatment may work.
  • Phase 3: A larger trial phase that compares treatments and helps confirm how well they work.
  • Established status epilepticus: A serious seizure emergency where seizures keep going or come back without full recovery in between.
  • Benzodiazepine-resistant: Not controlled by the first seizure medicine group called benzodiazepines.
  • Pathologic complete tumor regression: A very strong treatment response seen when the tumor disappears or is no longer found in tissue after treatment.
  • TRG1: A tumor regression grade showing the best or near-best response in the study’s grading system.
  • Maximum tolerated dose (MTD): The highest dose that can be given without causing too many serious side effects in a study.
  • Intravenous infusion: A treatment given through a vein over time.
  • Preoperative: Before surgery.

References