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Blinking and Yawning in Epilepsy: The Role of Dopamine (BYE BYE DOPA)

This study is currently recruiting participants.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01432821
First received: June 14, 2011
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Idiopathic Generalized Epilepsy
 Other: Apomorphine (Experimental product)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Dopaminergic Reactivity In Idiopathic Generalized Epilepsy: A "Proof Of Concept" Clinical, Pharmacological And Neurophysiological Study

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Number of yawn [ Time Frame: 60 minutes after injections ] [ Designated as safety issue: No ]
    Number of yawn at 60 minuts after the injection of apomorphine in patients with idiopathic generalized epilepsy compared to healthy volunteers.

  • Number of eyelid blinking [ Time Frame: 60 minutes after injections ] [ Designated as safety issue: No ]
    Number of eyelid Blinking at 60 minuts after the injection of apomorphine in patients with idiopathic generalized epilepsy compared to healthy volunteers.


Secondary Outcome Measures:
  • Number of yawn [ Time Frame: at 60 minutes after injections ] [ Designated as safety issue: No ]
    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.

  • Number of eyelid blinking in both groups after apomorphin or placebo injection [ Time Frame: at 60 minutes after injections ] [ Designated as safety issue: No ]
    The number of eyelid blinking after apomorphin or placebo injection is compare in both groups

  • Neurophysiological assessment of the dopaminergic reactivity [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]
    Number and cumulated duration of Spike-waves discharge assessed after injection of apomorphine in patients with idiopathic generalized epilepsy

  • To test the correlation between the behavioral and neurophysiological markers of dopaminergic reactivity in patients with epilepsy [ Time Frame: 60 min ] [ Designated as safety issue: No ]
    Correlation between yawning/blinking and the number of Spike-wave discharges in patients with epilepsy (Pearson test)

  • To assess dopaminergic reactivity with biological markers [ Time Frame: 60 min ] [ Designated as safety issue: No ]
    Comparison between plasma concentrations of prolactin and growth hormone (GH) in patients and controls after injection of apomorphine or placebo.

  • Number of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    This is a descriptive outcome. The number of each adverse event occured at 4 weeks will be listed

  • Check the absence of spike-wave discharges in healthy volunteers [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]
    EEG analysis


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apomorphine

After randomization healthy volunteers or patients with idiopathic generalized epilepsy receive:

-sequence A: 1 mg/kg and then 5 mg/kg of apomorphine

 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
Placebo Comparator: Saline

After randomization healthy volunteers or patients with idiopathic generalized epilepsy receive:

sequence B: 2 injections of saline

 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432821

Contacts
Contact: Jean-Luc CRACOWSKI 0033 4 76 76 92 60 JLCracowski@chu-grenoble.fr

Locations
France
CIC Department - University Hospital of Grenoble Recruiting
La Tronche, Isere, France, 38700
Contact: Laurent VERCUEIL, Doctor     00 33 4 76 76 55 61     LVercueil@chu-grenoble.fr    
Principal Investigator: Laurent VERCUEIL, Doctor            
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Laurent VERCUEIL, Doctor Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01432821     History of Changes
Other Study ID Numbers: C10-27
Study First Received: June 14, 2011
Last Updated: September 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Epilepsy,
dopamine
yawning,
blinking eyelids,
electroencephalography

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Generalized
Myoclonus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Apomorphine
Dopamine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013