A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome

ClinicalTrials.gov ID: NCT07503444

Public ClinicalTrials.gov record NCT07503444. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 28, 2026, 3:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study With Open-Label Extension to Evaluate the Efficacy And Safety of Fenfluramine Hydrochloride in Study Participants With Rett Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to investigate the efficacy of fenfluramine hydrochloride (HCl) versus placebo in study participants with Rett syndrome (RTT).

Study identification

NCT ID: NCT07503444
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: UCB BIOSCIENCES, Inc.; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Rett Syndrome

Interventions

fenfluramine hydrochloride Drug
Placebo Other

Drug · Other

Eligibility (public fields only)

Age range: 5 Years to 35 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 14, 2026 (Actual)
Primary completion: Feb 6, 2029 (Estimated)
Completion: Aug 29, 2031 (Estimated)
Last update posted: Oct 15, 2026

2026 – 2031

United States locations

U.S. sites: 8
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
Ep0247 21010	Little Rock	Arkansas	72202	Recruiting
Ep0247 21009	Miami	Florida	33155	Recruiting
Ep0247 21011	Orlando	Florida	32806	Recruiting
Ep0247 21007	Atlanta	Georgia	30322	Recruiting
Ep0247 21003	Philadelphia	Pennsylvania	19104-4318	Recruiting
Ep0247 21005	Houston	Texas	77030	Recruiting
Ep0247 21013	Irving	Texas	75062	Recruiting
Ep0247 21004	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07503444, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 15, 2026 · Synced Oct 28, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07503444 live on ClinicalTrials.gov.

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