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Efavirenz for the Treatment of Creutzfeldt-Jakob Disease Phase 3 246 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT07482085 is designed to study Treatment for Creutzfeldt-Jakob Disease. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 March 2026 until the study accrues 246 participants. Led by Xuanwu Hospital, Beijing, this study is expected to complete by 1 December 2028. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief Summary
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 efaviren...
Show MoreOfficial 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
Conditions
Creutzfeldt-Jakob DiseasePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 临研审[2026]009号-002
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
246
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Creutzfeldt-Jakob disease
efavirenz
efavirenz
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalEfavirenz Treatment Arm Participants will receive oral efavirenz at a dose of 200 mg once daily (1 tablet per dose). After 1 week of continuous treatment, the dose will be increased to 400 mg once daily (2 tablets per dose). To reduce central nervous system-related adverse effects, administration at bedtime is recommended.
Participants will continue study treatment under double-blind conditions from the time of randomization until the prim...Show More | Efavirenz The study drug in this trial is Efavirenz, and the control is a matching placebo. Efavirenz is supplied as 200 mg film-coated tablets. The placebo tablets are identical in appearance, color, and size to the Efavirenz tablets but contain no active ingredient. The main excipients of the placebo include lactose, microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, hydroxypropyl cellulose, sodium laur...Show More |
Placebo ComparatorPlacebo Control Arm Participants will receive oral placebo tablets that are identical in appearance, color, and size to efavirenz tablets at a dose of 200 mg once daily (1 tablet per dose). After 1 week of continuous treatment, the dose will be increased to 400 mg once daily (2 tablets per dose).
Participants will continue study treatment until the primary study endpoint is reached or the study is completed. All other treatment procedu...Show More | Placebo The study drug in this trial is Efavirenz, and the control is a matching placebo. Efavirenz is supplied as 200 mg film-coated tablets. The placebo tablets are identical in appearance, color, and size to the Efavirenz tablets but contain no active ingredient. The main excipients of the placebo include lactose, microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, hydroxypropyl cellulose, sodium laur...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Median survival time | The median number of days from randomization to death | From randomization to death, assessed up to 36 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to Loss of Independent Feeding Ability | Time from randomization to the first occurrence of loss of independent feeding ability, defined as the first time the feeding item in the Barthel Index drops to 0 (days) | From randomization until the feeding item in the Barthel Index first reaches 0, assessed up to 36 months |
Time to Loss of Bowel and Bladder Control | Time from randomization to the first occurrence of loss of bowel and bladder control, defined as the first time both "bowel control" and "bladder control" items in the Barthel Index drop to 0 (days) | From randomization until both bowel and bladder control items in the Barthel Index first reach 0, assessed up to 36 months |
Time to Development of Akinetic Mutism | Time from randomization to the onset of akinetic mutism, defined as the time at which the patient is independently assessed and jointly confirmed by two investigators to have no spontaneous movements but maintains a sleep-wake cycle (days) | From randomization until the patient meets criteria for akinetic mutism, assessed up to 36 months |
Changes in MRC-PDRS and Barthel Index Scores | Changes in functional assessment scores from randomization to each pre-specified follow-up time point, including MRC-PDRS scores and Barthel Index scores, assessed monthly via telephone follow-up interviews with the patient or caregiver | From randomization to each monthly follow-up assessment, assessed every month up to 36 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Xuanwu Hospital, BeijingStudy Central Contact
Contact: Zhongyun Chen, MD, +86-10-1365-100-6467, [email protected]
1 Study Locations in 1 Countries
Xuanwu Hospital, Capital Medical University, Beijing, 100053, China
Yan Yin, Contact, 010-83199270, [email protected]
Liyong Wu, MD, Principal Investigator