Status:
COMPLETED
Blinking and Yawning in Epilepsy: The Role of Dopamine
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Idiopathic Generalized Epilepsy
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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 health...
Detailed Description
Clinical data regarding the effects of dopaminergic drugs in idiopathic generalized epilepsies are scarce. The general observation that antipsychotic agents (dopaminergic antagonists) worsen seizures,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01432821
Start Date
September 1 2011
End Date
December 1 2014
Last Update
November 7 2016
Active Locations (1)
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1
CIC Department - University Hospital of Grenoble
La Tronche, Isere, France, 38700