Idiopathic Generalized Epilepsy | Blinking and Yawning in Epilepsy: The Role of Dopamine
Idiopathic Generalized Epilepsy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: For patients: - Men and women aged between 18 and 40 - Person affiliated to social security or beneficiary of such a regime - idiopathic generalized epilepsy treated with lamotrigine, an association of lamotrigine, topiramate, levetiracetam, lamotrigine or levetiracetam alone (group patients) for at least 14 days without changing doses The idiopathic generalized epilepsy is defined by generalized seizures: generalized tonic-clonic seizures, absences or myoclonic seizures, excluding any other type of seizure, and electroencephalographic appearance following: presence of interictal EEG discharge generalized to type of spikes, spike-wave or wave polyspikes generalized, sporadic or rhythmic> or = 3 Hz background activity is normal. For healthy volunteers: - Men and women aged between 18 and 40 - Person affiliated to social security or beneficiary of such a regime Exclusion Criteria: - Topic wrongly included - Deflecting protocol that can skew the primary endpoint - Primary endpoint missing - If the investigator considers the health of the subject is incompatible with the continuation of the study. Criteria for non-inclusion - For patients: - The presence of interictal focal discharges on EEG previous - The emergence of partial seizures - Restless Leg Syndrome - All non-antiepileptic treatment may affect levels of dopamine - Current use of illicit drugs. - A person deprived of liberty by judicial or administrative person being a measure of legal protection. - Pregnant, parturient, lactating mother. - For women, lack of effective contraception - For healthy volunteers: - Any medical treatment associated - Current use of illicit drugs - Pregnant, parturient, lactating mother - For women, lack of effective contraception - A person deprived of liberty by judicial or administrative person being a measure of legal protection.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Idiopathic Generalized Epilepsy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Apomorphine (Experimental product)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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ApomorphineAfter randomization healthy volunteers or patients with idiopathic generalized epilepsy receive: -sequence A: 1 mg/kg and then 5 mg/kg of apomorphine
SalineAfter randomization healthy volunteers or patients with idiopathic generalized epilepsy receive: sequence B: 2 injections of saline
Start Date: September 2011
Completed Date: December 2014
Primary Outcome: Number of yawn
Secondary Outcome: Number of yawn
Study sponsors, principal investigator, and references
Principal Investigator: Laurent VERCUEIL, Doctor
Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Ahmad S, Fowler LJ, Whitton PS. Effect of acute and chronic lamotrigine on basal and stimulated extracellular 5-hydroxytryptamine and dopamine in the hippocampus of the freely moving rat. Br J Pharmacol. 2004 May;142(1):136-42. Epub 2004 Mar 22.
Ahmad S, Fowler LJ, Whitton PS. Lamotrigine, carbamazepine and phenytoin differentially alter extracellular levels of 5-hydroxytryptamine, dopamine and amino acids. Epilepsy Res. 2005 Feb;63(2-3):141-9.
Aymard G, Berlin I, de Brettes B, Diquet B. Pharmacokinetic-pharmacodynamic study of apomorphine's effect on growth hormone secretion in healthy subjects. Fundam Clin Pharmacol. 2003 Aug;17(4):473-81.
Biraben A, Semah F, Ribeiro MJ, Douaud G, Remy P, Depaulis A. PET evidence for a role of the basal ganglia in patients with ring chromosome 20 epilepsy. Neurology. 2004 Jul 13;63(1):73-7.
Blin O, Masson G, Azulay JP, Fondarai J, Serratrice G. Apomorphine-induced blinking and yawning in healthy volunteers. Br J Clin Pharmacol. 1990 Nov;30(5):769-73.