Epilepsy Clinical Trial
Official title:
Efficacy of Fluoxetine Against Seizure-induced Central Apneas : a Randomized Placebo-controled Double-blind Trial.
Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that
primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP
incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood,
it appears that the majority of such death occurs in the immediate aftermath of a general
tonic-clonic seizure.
There is currently no validated preventive treatment for SUDEP. Some evidence suggest that
modulation of the serotoninergic tone, and more specifically selective serotonin recapture
inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents
seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models
of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the
control of breathing, especially during sleep and in response to repeated hypoxia.
In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of
seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a
risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs
displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.
The investigators project aimed at testing whether fluoxetine can reduce the risk of
ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled
trial in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of
their focal drug-resistant epilepsy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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