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HYALURONIDASE

Clinical trials are investigating HYALURONIDASE as part of a study in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The trial is looking at whether the study treatment can reduce symptoms and how the symptom score changes over time. It focuses on adults with moderate to severe ME/CFS.

Table of Contents

Trial overview

One authorized clinical trial is studying HYALURONIDASE in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).[1] The trial is titled “Plasma cell targeting in ME/CFS” and is designed as an interventional study.[1]

Study population

The trial is focused on people with moderate to severe ME/CFS.[1] The source data do not give more detailed entry rules, but the study is clearly aimed at this patient group.[1]

Study design and phase

This study is in Phase 2 and has a planned enrollment of 66 people.[1] Phase 2 studies usually look more closely at whether a treatment may help and continue to collect study results in a defined patient group.[1]

What the trial measures

The main outcome is the course of the DSQ-SF total score from baseline through follow-up until week 60.[1] In simple terms, this means researchers are tracking how symptom scores change from the start of the study to later visits.[1]

Treatment and comparison

The trial brief summary says the study is evaluating the efficacy of daratumumab versus placebo for reducing ME/CFS symptoms.[1] HYALURONIDASE is listed as one of the study interventions, given by subcutaneous injection with the other study drug.[1]

A placebo is a look-alike treatment used for comparison, so researchers can see whether the study treatment makes a real difference.[1] The trial is therefore looking at symptom improvement over time in a controlled setting.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-520094-13-00Phase 2Myalgic Encephalomyelitis/Chronic Fatigue SyndromeAuthorised66

FAQ

  • What clinical trial is studying HYALURONIDASE? One authorized Phase 2 trial is studying HYALURONIDASE in people with ME/CFS. It is part of an interventional study, which means the researchers give a treatment and measure the results.
  • Who can take part in the trial? The trial targets people with moderate to severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. The trial data do not give more detailed participation rules.
  • What is the trial trying to find out? The main goal is to see whether the study treatment can reduce ME/CFS symptoms. Researchers are also tracking how the symptom score changes from the start of the study through week 60.
  • What phase is the HYALURONIDASE trial? The study is in Phase 2. Phase 2 trials usually look more closely at whether a treatment may work and continue to collect safety and outcome data.
  • What outcome is being measured? The main outcome is the course of the DSQ-SF total score from baseline through follow-up until week 60. This score is used to track symptom change over time.

Ongoing Clinical Trials on HYALURONIDASE

  • Study on Daratumumab for Reducing Symptoms in Patients with Moderate to Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

    Recruiting

    2 1 1
    Investigated drugs:
    Norway

Glossary

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A long-term illness with severe fatigue and other symptoms. The trial is studying people with moderate to severe ME/CFS.
  • Interventional study: A study in which researchers give a treatment or intervention and then measure what happens.
  • Phase 2: A trial stage that looks more closely at whether a treatment may work and continues to collect study data.
  • Authorized: The study has been approved to start.
  • Enrollment: The number of people planned for the study.
  • DSQ-SF: A symptom questionnaire score used in the trial to follow changes in symptoms over time.
  • Baseline: The starting point before treatment or study follow-up begins.
  • Follow-up: The period after treatment starts when researchers keep checking study results.
  • Week 60: The time point 60 weeks after the study begins, used for later outcome measurement.
  • Placebo: A look-alike treatment with no active study medicine, used for comparison in some trials.

References

  1. https://clinicaltrials.gov/study/2024-520094-13-00