At a glance
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Dopaminergic Reactivity In Idiopathic Generalized Epilepsy: A "Proof Of Concept" Clinical, Pharmacological And Neurophysiological Study
In Brief
A clinical study evaluating Apomorphine (Experimental product) for Idiopathic Generalized Epilepsy. Completed, enrolled 31 participants across 1 site.
Detailed Summary
The objective of the present study is to assess dopaminergic reactivity with behavioural markers (i.e. yawning and blinking) in patients with idiopathic generalized epilepsy compared to matched healthy controls, after injection of either low dose of apomorphine or placebo. Other parameters will be recorded: biochemical (prolactin, GH) and neurophysiological (Spike-Waves Discharge: SWD rating). Safety parameters will be recorded to assess tolerance.
Study Details
Timeline
Interventions
Dosage Form: Injection Dosage: 1 or 5 mg / kg Route of administration: Subcutaneous Duration of treatment: two injections of apomorphine followed by two injections of a placebo one week after or vice versa. Two injections will be made by visiting during visits 2 and 3. The study was conducted cross-over with two visits EEG recording, the order will be randomized injections: * Sequence A during visit 2 followed by sequence B during visit 3 * or sequence B during visit 2