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NCT07503444 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
A Phase 3 study, sponsored by UCB Biosciences.
- Not yet
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT07503444: Clinical Trial Phase 3 study, sponsored by UCB Biosciences.
NCT07503444 is a Phase 3 study that has not yet begun recruiting, run by UCB Biosciences. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07503444, a Phase 3 study, has not yet begun recruiting, sponsored by UCB Biosciences.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy of fenfluramine hydrochloride (HCl) versus placebo in study participants with Rett syndrome (RTT).
Primary Outcome
The RSBQ is a caregiver-completed, instrument assessing behavioral and emotional features in RTT. The RSBQ consists of 45 items, including 8 subscales: General mood (8 items); Breathing problems (5 items); Hand behavior (6 items); Face movements (4 items); Body rocking and expressionless face (6 items); Nighttime behaviors (3 items); Fear/anxiety (4 items); and Walking/standing (2 items). Caregivers are asked to evaluate each RTT feature based on the current status of the patients on a 3-point s
Interventions
- OTHER Placebo
- DRUG fenfluramine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2030-11-15 |
| Phase | Phase 3 |
What is known before NCT07503444 opens enrollment
NCT07503444 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07503444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07503444 about?
NCT07503444 is a clinical study titled "A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome". The purpose of this study is to investigate the efficacy of fenfluramine hydrochloride (HCl) versus placebo in study participants with Rett syndrome (RTT).
What is the current status of trial NCT07503444?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2026-06-30. Estimated completion is 2030-11-15.
What interventions are being tested in trial NCT07503444?
The interventions under investigation include: Placebo (OTHER), fenfluramine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT07503444?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07503444's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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