Idiopathic Generalized Epilepsy Clinical Trial
— BYE BYE DOPAOfficial title:
Dopaminergic Reactivity In Idiopathic Generalized Epilepsy: A "Proof Of Concept" Clinical, Pharmacological And Neurophysiological 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.
Status | Completed |
Enrollment | 31 |
Est. completion date | December 2014 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | CIC Department - University Hospital of Grenoble | La Tronche | Isere |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Santé Et de la Recherche Médicale, France |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of yawn | Number of yawn at 60 minuts after the injection of apomorphine in patients with idiopathic generalized epilepsy compared to healthy volunteers. | 60 minutes after injections | No |
Primary | Number of eyelid blinking | Number of eyelid Blinking at 60 minuts after the injection of apomorphine in patients with idiopathic generalized epilepsy compared to healthy volunteers. | 60 minutes after injections | No |
Secondary | Number of yawn | Evolution of yawn number between base line period and the 60 minuts following the injection of apomorphine in patients with idiopathic generalized epilepsy compared to healthy volunteers matched. | at 60 minutes after injections | No |
Secondary | Number of eyelid blinking in both groups after apomorphin or placebo injection | The number of eyelid blinking after apomorphin or placebo injection is compare in both groups | at 60 minutes after injections | No |
Secondary | Neurophysiological assessment of the dopaminergic reactivity | Number and cumulated duration of Spike-waves discharge assessed after injection of apomorphine in patients with idiopathic generalized epilepsy | 60 min | Yes |
Secondary | To test the correlation between the behavioral and neurophysiological markers of dopaminergic reactivity in patients with epilepsy | Correlation between yawning/blinking and the number of Spike-wave discharges in patients with epilepsy (Pearson test) | 60 min | No |
Secondary | To assess dopaminergic reactivity with biological markers | Comparison between plasma concentrations of prolactin and growth hormone (GH) in patients and controls after injection of apomorphine or placebo. | 60 min | No |
Secondary | Number of Adverse Events as a Measure of Safety and Tolerability | This is a descriptive outcome. The number of each adverse event occured at 4 weeks will be listed | 4 weeks | Yes |
Secondary | Check the absence of spike-wave discharges in healthy volunteers | EEG analysis | 60 min | Yes |
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