Pilot Study of the Effects of the Desipramine on the Neurovegetative Parameters of the Child With Rett Syndrome
NCT ID: NCT00990691
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2009-02-17
2017-08-21
Brief Summary
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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.
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Detailed Description
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Only a few improved cases have been reported concerning buspirone (Andaku, 2005, 1 patient), topiramate (Goyal, 2004, 8 patients), diazepam (Kurihara, 2001, 1 patient) and carnitin (Plochl, 2004, 1 patient).
Only one randomized study versus placebo has been published about a treatment by naltrexone including 25 patients. A light improvement of respiratory parameters was then observed with a deterioration of the cognitive function (Percy, 2004).
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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Desipramine high dose
12 patients with Rett syndrome receiving a daily dose of desipramine correlated with the 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.
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.
Desipramine low dose
12 patients with Rett syndrome receiving a daily dose of desipramine correlated with the 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.
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.
Placebo
12 patients with Rett syndrome receiving a daily dose of placebo.
Administration of a placebo
Administration of a daily dose of placebo
Interventions
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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.
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.
Administration of a placebo
Administration of a daily dose of placebo
Eligibility Criteria
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Inclusion Criteria
* Girls weighing less than 60 kg;
* Respiratory alteration;
* Diagnosis of Rett syndrome confirmed by MECP2 genotyping (Xq28).
Exclusion Criteria
* Pregnancy and breath feeding;
* Case history of status epilepticus;
* Patient treated by IMAO or sultopride;
* Hepatic or renal failure.
4 Years
18 Years
FEMALE
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Josette Mancini
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique Hopitaux De Marseille
Locations
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Assistance Publique - Hopitaux de Marseille
Marseille, , France
Countries
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References
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Mancini J, Dubus JC, Jouve E, Roux JC, Franco P, Lagrue E, Castelnau P, Cances C, Chaix Y, Rougeot-Jung C, Cornu C, Desportes V, Vallee L, Bahi-Buisson N, Truillet R, Attolini L, Villard L, Blin O, Micallef J. Effect of desipramine on patients with breathing disorders in RETT syndrome. Ann Clin Transl Neurol. 2017 Dec 27;5(2):118-127. doi: 10.1002/acn3.468. eCollection 2018 Feb.
Other Identifiers
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2007-006739-30
Identifier Type: -
Identifier Source: secondary_id
2007-37
Identifier Type: -
Identifier Source: org_study_id
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