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Open Label Trial of Triheptanoin (UX007) in Treatment of Rett Syndrome.

NCT03059160 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-02-23

No results posted yet for this study

Summary

This is a single-center, exploratory, open-label study in 10 girls diagnosed with Rett Syndrome. The study will consist of the following 4 parts: Screening/Baseline run-in, Titration/Dose-Setting, Treatment, and Washout/Follow-up.

Conditions

Interventions

DRUG

Tridecanoic Acid

3 times daily oral doze of the drug for 20 weeks with 4 weeks of baseline and 4 weeks of washout

Sponsors & Collaborators

Principal Investigators

  • Bruria Ben-Zeev, MD · Head of pediatric neurology unit in Sheba medical center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-04-01
Completion
2018-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059160 on ClinicalTrials.gov