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Mbf-015

Clinical trials are investigating Mbf-015 in people with Huntington’s disease. This article explains what the study is testing, who took part, and which results were measured, such as safety, tolerability, and early signs of benefit. The available trial is a phase 2 study with a small group of patients.

Table of Contents

Trial overview

This clinical trial studied Mbf-015 in people with Huntington’s disease.[1] The study was designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy over a 28-day treatment period.[1]

The trial was completed and enrolled 10 participants.[1]

Study design and phase

This was a phase 2 study, which means it was a mid-stage trial that looked more closely at how the treatment performed in patients.[1] It was also open label, so the research team and the participants knew what treatment was being given.[1]

The study was single centre, meaning it took place at one research site.[1] The intervention was oral Mbf-015, given as 32 mg by mouth.[1]

Who participated

The target population was people with Huntington’s disease.[1] The brief summary says the trial studied Mbf-015 in participants with Huntington’s disease on top of standard of care, which means usual treatment was continued during the study.[1]

Because only 10 people were enrolled, this was a small study meant to gather early clinical information rather than prove long-term benefit.[1]

What was measured

The main endpoint was safety and tolerability from baseline to the end of follow-up on day 43.[1] Safety means whether the treatment caused harmful problems, and tolerability means how well patients could handle the treatment.[1]

Researchers counted and graded adverse events, which are unwanted medical problems that happen during a study.[1] They also looked for clinically significant changes in vital signs, physical examination findings, laboratory measurements, ECGs, and the Columbia-Suicide Severity Rating Scale (C-SSRS).[1]

The study also aimed to assess pharmacokinetics and pharmacodynamics.[1] Pharmacokinetics describes how the body handles a treatment, while pharmacodynamics describes how the treatment affects the body.[1]

Safety and follow-up tracking

Participants were followed for 28 days of treatment, with follow-up continuing to day 43.[1] This follow-up period helped the researchers watch for later safety findings after the main treatment period ended.[1]

The available trial data do not report detailed outcome results in the source, but they do show that the study was completed and focused on early clinical evaluation of Mbf-015 in Huntington’s disease.[1]

Trial ID Phase Condition studied Status Enrollment
2023-505241-10-00 Phase 2 Huntington’s disease Completed 10

FAQ

  • What is being studied in the Mbf-015 trial? The trial studied Mbf-015 in people with Huntington's disease. It looked at safety, tolerability, and early signs of benefit over 28 days.
  • Who could take part in the study? The study enrolled participants with Huntington's disease. It was a small, single-centre trial, so the group was limited.
  • What phase was the Mbf-015 trial? This was a phase 2 study. Phase 2 trials usually look more closely at safety and early effectiveness in patients.
  • What results did the researchers measure? The main result was safety and tolerability. Researchers also checked side effects, vital signs, physical exams, lab tests, ECGs, and suicide risk screening.
  • Was the study completed? Yes, the trial status was completed. The study followed participants for 28 days, with follow-up until day 43.

Ongoing Clinical Trials on Mbf-015

  • Study on the Safety and Effects of MBF-015 for Patients with Huntington’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Huntington's disease: A brain disease that gets worse over time and can affect movement, thinking, and behavior.
  • Phase 2: A mid-stage clinical trial that looks at safety and early signs that a treatment may help.
  • Open label: A study design where both the researchers and participants know what treatment is being given.
  • Single centre: A study done at one hospital or research site.
  • Interventional study: A trial where researchers give a treatment and then observe the effects.
  • Safety: How well a treatment is tolerated and whether it causes harmful effects.
  • Tolerability: How manageable the treatment is for the patient, especially in terms of side effects.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Pharmacodynamics: How a treatment affects the body.
  • ECG: A heart test that records the electrical activity of the heart.
  • C-SSRS: A questionnaire used to check for suicidal thoughts or behavior.
  • Adverse events: Medical problems or unwanted effects that happen during a study.

References

  1. https://clinicaltrials.gov/study/2023-505241-10-00