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NCT07150013
Rett REVOLUTION Trial: An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Rett Syndrome
Phase 1 trial testing Vorinostat (SAHA) in Rett Syndrome in 15 participants. Not yet recruiting.
15 July 2026
Quick facts
| Lead sponsor | Unravel Biosciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 October 2025 |
| Primary completion | 15 July 2026 |
| Estimated completion | 15 October 2026 |
| Sites | 1 location across Colombia |
Drugs / interventions tested
- Vorinostat (SAHA) — full drug profile →
- Placebo
Conditions studied
- Rett Syndrome — all drugs for Rett Syndrome →
Sponsor
Unravel Biosciences, Inc. — full company profile →
Who can join
Adults 6 to 21, female only, with Rett Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The RETT REVOLUTION trial is a placebo-controlled, single-blinded, exploratory study with patients serving as their own control ("N of 1" trial design) where the safety and efficacy of vorinostat in the treatment of Rett syndrome will be evaluated. Each patient will be self-controlled in an adapted N-of-1 study design methodology by using a 4-week placebo baseline. Vorinostat dose escalation will occur every 8 weeks of daily dosing: placebo, 80mg/m2/day, 160mg/m2/day. Key study objectives will include: * To confirm the safety and tolerability of oral vorinostat 80mg/m2/day and 160mg/ m2/day dose levels when administered to typical Rett patients * To identify the nature and magnitude of treatment response to vorinostat, as measured by changes in clinical and laboratory parameters indicative of trend towards benefit, as well as changes in mRNA expression (transcriptome response) * Provide a data-driven justification for future study design and statistical analysis plan for subsequent clinical studies assessing safety and efficacy of vorinostat in Rett syndrome
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07150013
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vorinostat (SAHA)
Trials testing the same drug.
- NCT07150026 — An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Pitt Hopkins Syndrome · Phase 1 · not yet recruiting
- NCT01132911 — A Phase I Study of Vorinostat and Bortezomib in Children With Refractory of Recurrent Solid Tumors, Including CNS Tumors · Phase 1 · completed
Other recruiting trials for Rett Syndrome
Currently open trials in the same condition.
- NCT06840496 — To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome · Phase 3 · recruiting
- NCT07151950 — Obi Medical Robot: Evaluating Effectiveness Related to Usability · active not recruiting
- NCT06856759 — Single-Dose AAV-MECP2 Safety/Tolerability and Efficacy in Rett Syndrome · EARLY_PHASE1 · recruiting
- NCT07418905 — Technology-supported Motor Rehabilitation for People With Rett Syndrome · NA · active not recruiting
- NCT06152237 — Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study) · Phase 1, PHASE2 · active not recruiting
Other Unravel Biosciences, Inc. trials
Trials by the same sponsor.
- NCT07150026 — An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Pitt Hopkins Syndrome · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07150013 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Unravel Biosciences, Inc.
- Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07150013.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing