A Safety Study of NNZ-2566 in Pediatric Rett Syndrome

Summary

The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Rett syndrome in children and adolescents.

Conditions

• Rett Syndrome

Interventions

DRUG

NNZ-2566

Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.

DRUG

Placebo

Strawberry flavored solution and Water for Injection

Sponsors & Collaborators

• rettsyndrome.org

  collaborator UNKNOWN

• Neuren Pharmaceuticals Limited

  lead INDUSTRY

Principal Investigators

• Daniel Glaze, MD · Baylor College of Medicine

• Alan Percy, MD · University of Alabama at Birmingham

• Timothy Feyma, MD · Gillette Children's Specialty Healthcare

• Peter Heydemann, MD · Rush University Medical Center

• Jeff Neul, MD · University of California, San Diego

• Tim Benke, MD · Children's Hospital Colorado

• Mary Jones, MD · UCSF Benioff Children's Hospital Oakland

• Steve Skinner, MD · Greenwood Genetic Center

• Mustafa Sahin, MD · Boston Children's Hospital

• Sarika Peters, PhD · Vanderbilt University

• Shannon Standridge · Children's Hospital Medical Center, Cincinnati

• Eric Marsh, MD · Children's Hospital of Philadelphia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

15 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2017-01-05

Completion

2017-01-05

Countries

• United States

Study Locations