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A Safety Study of NNZ-2566 in Patients With Rett Syndrome

NCT01703533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-02-05

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

NNZ-2566

Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) 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

  • Baylor College of Medicine

    collaborator OTHER

  • International Rett Syndrome Foundation

    collaborator OTHER

  • Neuren Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Daniel G Glaze, M.D. · Baylor College of Medicine

  • Jeffrey L Neul, M.D., Ph.D. · Baylor College of Medicine

  • Alan Percy, MD · University of Alabama at Birmingham

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

  • Arthur Beisang, MD · Gillette Children's Specialty Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01703533 on ClinicalTrials.gov