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โ† Trials
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Efavirenz for the Treatment of Creutzfeldt-Jakob Disease

RecruitingPhase 3Ages 18 Years - 80 YearsAllXuanwu Hospital, Beijing
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of efavirenz in patients with Creutzfeldt-Jakob disease (CJD). A total of 246 eligible participants will be enrolled across 21 study centers nationwide. Participants will be randomly assigned in a 1:1 ratio to receive either efavirenz or placebo. Participants in the efavirenz group will receive 200 mg once daily at bedtime for the first week, followed by an increased dose of 400 mg once daily thereafter. Participants in the placebo group will receive matching placebo tablets using the same dosing schedule. Treatment will be administered under double-blind conditions and will continue until death or study completion. During the study, all participants will receive monthly telephone follow-up assessments starting from treatment initiation to eval

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients who meet the World Health Organization (WHO) diagnostic criteria for probable sporadic CJD or have a genetically confirmed diagnosis of hereditary CJD. * Age 18-80 years, any sex. * Baseline score on the Medical Research Council Prion Disease Rating Scale (MRC-PDRS) \>10 (i.e., retaining some functional ability). * The patient has a caregiver aged โ‰ฅ18 years who can accompany the patient during the study and assist in providing relevant information. * The patient or their legally authorized representative has signed the informed consent form. Exclusion Criteria: * Presence of severe somatic diseases or unstable clinical conditions that may affect study compliance or patient safety, including malignancy, advanced liver or kidney dysfunction, severe cardiac disease (including patients with a history of significant QTc prolongation). * Current use of drugs that are known contraindications with efavirenz and cannot be discontinued or substituted. * Female participants who are pregnant or breastfeeding. * Other medical or psychiatric conditions, as judged by the investigator, that may interfere with the patient's participation in or completion of the study.
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What it tests

  • Efavirenz
  • Placebo
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Where

1 site
Xuanwu Hospital, Capital Medical University
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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