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NCT02019667 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Seizures and Metabolic Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
Phase 2
Development phase
19
Enrollment target
2
Study locations

NCT02019667: Completed Phase 2 study of Seizures and Metabolic Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT02019667 is a Phase 2 study of Seizures and Metabolic Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 19 participants, below the 934-participant average among 39 other Seizures trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02019667, a Phase 2 study of Seizures and Metabolic Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

The ABAS questionnaire was completed by the participant's parent or caregiver at the end of each six month treatment period.The ABAS provides a comprehensive picture of adaptive skills across the lifespan. The questionnaire addresses Conceptual, Social and Practical skills including communication, self-direction, use of leisure time, health, safety and self-care. The General Adaptive Composite score ranges from \<40 to \>160 with a lower score representing lower adaptive behavior. The difference

Interventions

  • DRUG Placebo
  • DRUG SGS-742

Study Locations (2)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Washington

  • Washington State University - Pullman

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2014-03-31
Est. Completion 2019-04-03
Phase Phase 2

What the finished NCT02019667 record still lists

NCT02019667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 934-participant average among 39 other Seizures trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Seizures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02019667 reports a single indexed study location in Maryland, Washington.

Frequently Asked Questions

What is clinical trial NCT02019667 about?

NCT02019667 is a clinical study titled "Phase 2 Clinical Trial of SGS-742 Therapy in Succinic Semialdehyde Dehydrogenase Deficiency". 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....

What is the current status of trial NCT02019667?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2014-03-31. Estimated completion is 2019-04-03.

What conditions does trial NCT02019667 study?

This clinical trial studies the following conditions: Seizures, Metabolic Disease.

What interventions are being tested in trial NCT02019667?

The interventions under investigation include: Placebo (DRUG), SGS-742 (DRUG).

Who is sponsoring clinical trial NCT02019667?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02019667 being conducted?

This trial has 2 study locations across Maryland, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Seizures

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02019667's enrollment target sits among peer trials

19 36th of 39 higher than 4 of 39 other Seizures trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Seizures 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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Source: ClinicalTrials.gov NCT02019667, the US trial registry maintained by the National Library of Medicine. NCT02019667 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.