Trial · NCT07904533
Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis
NCT07904533, Phase 3, Not yet recruiting, Beijing Ditan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis. Trials, record NCT07904533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904533
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis
- NCT number
- NCT07904533
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 778 participants, estimated
- Lead sponsor
- Beijing Ditan Hospital
- Conditions
- Neurosyphilis
- Interventions
- Minocycline, Minocycline placebo, Aqueous crystalline penicillin G
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants with favorable neurological outcomes at 6 months | At 6 months post-treatment | Unit of measure: Percentage (%). A favorable neurological outcome is defined as meeting both of the following criteria: (1) a modified Rankin Scale score of 0 to 2, AND (2) at least one of the following: an improvement in the Mini-Mental State Examination score of ≥2 points from baseline, or a Mini-Mental State Examination score of \>26. The Mini-Mental State Examination score ranges from 0 to 30, with higher scores indicating better cognitive function. The modified Rankin Scale score ranges from 0 to 6, with higher scores indicating worse disability. |
| Secondary | Proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts (≤5 cells/μL; or ≤20 cells/μL for participants with HIV) at 6 months, as measured by CSF analysis. |
| Secondary | Proportion of participants with normal cerebrospinal fluid (CSF) protein levels | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) protein levels (\<500 mg/L) at 6 months post-treatment, as measured by CSF biochemical analysis. |
| Secondary | Proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers. Titers are measured by Venereal Disease Research Laboratory (VDRL), toluidine red unheated serum test (TRUST), or rapid plasma reagin (RPR) tests on CSF samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable. |
| Secondary | Proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers, measured by toluidine red unheated serum test (TRUST) or rapid plasma reagin (RPR) tests on serum samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable. |
| Secondary | Proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2 | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2 at 6 months post-treatment. The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. A score of 0 to 2 indicates functional independence (a favorable outcome). Higher scores indicate worse disability. |
| Secondary | Proportion of participants with a ≥2-point improvement or a score >26 in the Mini-Mental State Examination | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants meeting at least one of the following criteria at 6 months: (1) an improvement of ≥2 points from baseline in the Mini-Mental State Examination (MMSE) score, or (2) an MMSE score of \>26. The MMSE is a 30-point questionnaire ranging from 0 to 30, where higher scores indicate better cognitive function. |
| Secondary | Change from baseline in the modified Rankin Scale (mRS) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the modified Rankin Scale (mRS) score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and 6 indicates death. Higher scores indicate worse disability. A negative value indicates an improvement (reduction in disability) from baseline. |
| Secondary | Change from baseline in the Mini-Mental State Examination (MMSE) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the MMSE score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The MMSE ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline. |
| Secondary | Change from baseline in the Montreal Cognitive Assessment (MoCA) Beijing version score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the Montreal Cognitive Assessment (MoCA) Beijing version score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The MoCA Beijing version ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers27
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904533
GET https://conductscience.org/api/trials/v1/NCT07904533/registered?page=2