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Pilot Study of the Effects of the Desipramine on the Neurovegetative Parameters of the Child With Rett Syndrome

NCT00990691 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-07-26

No results posted yet for this study

Summary

Rett syndrome is a neurodevelopmental disorder characterized by cognitive impairment, communication dysfunction, stereotypic movement disorder, and growth failure. Rett syndrome is caused by mutations in the Methyl CpG-Binding Protein-2 (MECP2) gene and has no treatment.

A mouse experimental model of Rett syndrome created by genetic invalidation of the MECP2 gene is available. It had been then observed that adult MECP2-deficient mice show respiratory alterations and found that endogenous noradrenaline helps to maintain a normal respiratory rhythm. Desipramine, a selective inhibitor of norepinephrine reuptake, seems to be efficient to reduce the respiratory alteration occuring in MECP2-deficient mice (Insem patent 2005, Villard and Roux 2006).

The aim of the study is to evaluate these obtained results in MECP2-deficient mice on patients with Rett syndrome.

Conditions

Interventions

DRUG

Administration of a high dose of desipramine

Administration of a daily dose of desipramine correlated with the patient's weight : * From 15 to 25 kg : 50 mg ; * From 26 to 35 kg : 75 mg ; * From 36 to 45 kg : 100 mg ; * \> 46 kg : 150 mg.

DRUG

Administration of a low dose of desipramine

Administration of a daily dose of desipramine correlated with the patient's weight : * From 15 to 25 kg : 25 mg ; * From 26 to 35 kg : 50 mg ; * From 36 to 45 kg : 75 mg ; * \> 46 kg : 100 mg.

DRUG

Administration of a placebo

Administration of a daily dose of placebo

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Josette Mancini · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-17
Primary Completion
2014-08-11
Completion
2017-08-21

Countries

  • France

Study Locations

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Entities

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 NCT00990691 on ClinicalTrials.gov