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

Plain-language summary

This is a pilot study comparing the effect of the drug Desipramine with placebo on neurovegetative functions such as breathing in girls with Rett syndrome. It included girls with breathing problems and a diagnosis confirmed by MECP2 gene analysis (Xq28). It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Assistance Publique Hopitaux De Marseille

Intervention

Administration of a high dose of desipramine, Administration of a low dose of desipramine, Administration of a placebo

Start date

2/17/2009

Estimated completion

8/21/2017

Countries

France

Related genes

Locations

• Marseille, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Rett syndrome;
* Girls weighing less than 60 kg;
* Respiratory alteration;
* Diagnosis of Rett syndrome confirmed by MECP2 genotyping (Xq28).

Exclusion Criteria:

* Boys;
* Pregnancy and breath feeding;
* Case history of status epilepticus;
* Patient treated by IMAO or sultopride;
* Hepatic or renal failure.