CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
SGS-742 +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.

Search/NCT02019667
NCT02019667Phase 2Completed

Phase 2 Clinical Trial of SGS-742 Therapy in Succinic Semialdehyde Dehydrogenase Deficiency

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Dec 24, 2013·Updated Feb 24, 2020

In Brief

A Phase 2 clinical trial evaluating SGS-742 and Placebo for Metabolic Disease and Seizures. Completed, enrolled 19 participants across 2 sites.

Detailed Summary

Objective: To perform a clinical trial assessing the safety, tolerability and efficacy of the GABA(B) receptor antagonist SGS-742 in patients with SSADH deficiency. Study Population: Twenty-two children and adults with SSADH deficiency. Design: Double-blind, cross-over, phase II clinical trial. Outcome Measures: The primary outcome measures for drug efficacy will be performance on neuropsychological testing and responses to parent questionnaire. The secondary outcome measure will be TMS parameters of cortical excitation and inhibition. The outcome measures for safety will include clinical examination and neuropsychological tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 24, 2013
Enrollment StartMar 31, 2014
Primary CompletionJan 31, 2019
Study CompletionApr 3, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.5 years ago

Interventions

SGS-742drug

Placebodrug