Trial · NCT07430046
Repurposing Mirtazapine in Rett Syndrome
NCT07430046, Phase 2, Recruiting, University of Trieste
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Repurposing Mirtazapine in Rett Syndrome. Trials, record NCT07430046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07430046
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Repurposing Mirtazapine in Rett Syndrome
- NCT number
- NCT07430046
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 54 participants, estimated
- Lead sponsor
- University of Trieste
- Conditions
- RETT Syndrome With Proven MECP2 Mutation
- Interventions
- mirtazapine
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoint: Improvement in the rating scale Motor-Behavior Assessment Scale (MBAS). | From enrollment to the end of treatment at 24 weeks | The drug will be considered effective if the treatment decreases the Motor-Behavior Assessment Scale (MBAS) score (maximum score=68) by at least 8.5 points (12.5%) compared to the pre-treatment value. |
| Secondary | Secondary endpoint 1. Reduced mood and anxiety disorder symptoms | From enrollment to the end of treatment at 24 weeks | 1\. The drug will be considered effective if the treatment reduces the overall Anxiety, Depression, Mood Scale (ADAMS) score (maximum score=84) by at least 10.6 points (12.5%) compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 1bis: Reduced mood and anxiety disorder symptoms | From enrollment to the end of treatment at 24 weeks | 1bis. The drug will be considered effective if is will reduce the overall Rett Syndrome Behaviour questionnaire (RSBQ) score by at least 11.25 points (12.5%) compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-a. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-a. The drug will be considered effective if the treatment improves the measurements of Respiratory Rate (RR), obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-b. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-b. The drug will be considered effective if the treatment improves the measurements of Heart Rate (HR), obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-c. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-c. The drug will be considered effective if the treatment improves the measurements of Variation of Heart Rate (VHR), obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-d. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-d. The drug will be considered effective if the treatment improves the measurements of Skin Temperature (SkT) obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 3-a: Improved Sleep quality | From enrollment to the end of treatment at 24 weeks | 3-a. The drug will be considered efficacious if the Sleep Disturbances Scale for Children (SDSC) scores will be reduced by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 3-b: Improved Sleep Quality | From enrollment to the end of treatment at 24 weeks. | 3-b: The drug will be considered efficacious if the estimated time in bed (eTIB) measured by wrist actigraphy will be increasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-c: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-c: The drug will be considered efficacious if the estimated total sleep time (eTST), measured by wrist actigraphy, will be increasing by 20% over the pre-treatment score. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07430046
GET https://conductscience.org/api/trials/v1/NCT07430046/registered?page=2