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Blinking and Yawning in Epilepsy: The Role of Dopamine

NCT01432821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Idiopathic Generalized Epilepsy

Interventions

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

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Laurent VERCUEIL, Doctor · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-12-31
Completion
2014-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432821 on ClinicalTrials.gov