At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
UX007 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Assess the Safety and Efficacy of UX007 in Subjects With Glucose Transporter Type 1 Deficiency Syndrome
In Brief
A Phase 2 clinical trial evaluating UX007 and Placebo for Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS). Completed, enrolled 36 participants across 14 sites in 7 countries.
Detailed Summary
The primary objectives of the study are to evaluate the efficacy of UX007 compared to placebo as measured by the reduction from randomization to Week 8 in frequency of seizures and to evaluate the safety of UX007 via adverse event (AE) rates, laboratory values, and electrocardiogram (ECG).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, France, Israel, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartFeb 2014
Primary CompletionSep 2017
TodayJul 2026
First PostedNov 25, 2013
Enrollment StartFeb 28, 2014
Primary CompletionSep 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.6 years ago
Interventions
UX007drug
oral liquid
Placebodrug
oral liquid