A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome

Summary

The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Fragile X Syndrome in adolescent and adult males.

Conditions

• Fragile X Syndrome

Interventions

DRUG

NNZ-2566

Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials or 3g in 30mL bottles) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.

DRUG

Placebo

Strawberry flavored solution

Sponsors & Collaborators

• Neuren Pharmaceuticals Limited

  lead INDUSTRY

Principal Investigators

• Elizabeth M Berry-Kravis, MD · Rush University Medical Center

• Joseph Cubells, MD, PhD · Emory University

• Alexander Kolevzon, MD · Icahn School of Medicine at Mount Sinai

• Nicole Tartaglia, MD · Children's Hospital Colorado

• Jean Frazier, MD · University of Massachusetts, Worcester

• Shivkumar Hatti, MD · Suburban Research Associates

• Craig Erickson, MD · Children's Hospital Medical Center, Cincinnati

• Thomas Challman, MD · Autism & Developmental Medicine Institute Geisinger Health System

• Kevin Sanders, MD · Vanderbilt University Medical Center

• Diane Treadwell-Deering, MD · Baylor College of Medicine

• Jeffrey Innis, MD · University of Michigan

• Howard Needleman, MD · University of Nebraska

• Steve Skinner, MD · Greenwood Genetic Center

• Bryan King, MD · Seattle Children's Hospital

• Randi Hagerman, MD · UC Davis MIND Institute

• Robert Findling, MD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2015-09-30

Completion

2015-10-31

Countries

• United States

Study Locations