Efavirenz for Creutzfeldt-Jakob Disease (CJD)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Efavirenz in Patients With Creutzfeldt-Jakob Disease
Run by Xuanwu Hospital, Beijing · NCT07482085 · Data updated 2026-11-12
This study tests whether efavirenz can help people with Creutzfeldt-Jakob disease compared with a placebo, across multiple centers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 246 (estimated) |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | April 14, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07482085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with probable sporadic or genetically confirmed hereditary CJD, a baseline MRC-PDRS score greater than 10, and a caregiver able to assist.
✕Probably not a fit
Patients with severe comorbid conditions, significant liver/kidney dysfunction, or contraindications to efavirenz may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial enrolling up to 246 participants with probable sporadic or hereditary CJD. Participants are assigned 1:1 to receive either efavirenz or matching placebo, starting at 200 mg at night for one week and then 400 mg daily, with treatment continuing until death or study end. Monthly follow-up calls monitor long-term safety and efficacy in all participants. The trial is conducted under rigorous blinding and oversight at 21 study centers, led by Xuanwu Hospital in Beijing.
Why it matters
Potential benefit: If successful, participants could experience slowed disease progression or improved quality of life due to efavirenz treatment.
How similar studies have gone: Previous approaches in prion diseases have been exploratory; this trial tests a well-established drug in a rigorous Phase 3 design for CJD.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 ≥18 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.
Where it's running
-
Xuanwu Hospital, Capital Medical University
Beijing, China Recruiting
Study contacts
- Study coordinator: Zhongyun Chen, MD
- Email: chenzhongyun3@163.com
- Phone: +86-10-1365-100-6467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.