After randomization healthy volunteers or patients with idiopathic generalized epilepsy receive:
-sequence A: 1 mg/kg and then 5 mg/kg of apomorphine

After randomization healthy volunteers or patients with idiopathic generalized epilepsy receive:
sequence B: 2 injections of saline

Idiopathic Generalized Epilepsy

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

Apomorphine (Experimental product)

CIC Department - University Hospital of Grenoble

Blinking and Yawning in Epilepsy: The Role of Dopamine

Dopaminergic Reactivity In Idiopathic Generalized Epilepsy: A "Proof Of Concept" Clinical, Pharmacological And Neurophysiological Study

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 at 60 minuts after the injection of apomorphine in patients with idiopathic generalized epilepsy compared to healthy volunteers.

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.

The number of eyelid blinking after apomorphin or placebo injection is compare in both groups

Number and cumulated duration of Spike-waves discharge assessed after injection of apomorphine in patients with idiopathic generalized epilepsy

Correlation between yawning/blinking and the number of Spike-wave discharges in patients with epilepsy (Pearson test)

Comparison between plasma concentrations of prolactin and growth hormone (GH) in patients and controls after injection of apomorphine or placebo.

This is a descriptive outcome. The number of each adverse event occured at 4 weeks will be listed

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

Tigan® : Oral capsule, 300mg three times daily.

Trimethobenzamide (Tigan®)

Placebo : Oral capsule, three times daily.

Placebo

Total

Period 1:
Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 134.
Overall Number of Baseline Participants in 'Placebo' arm is 46.

Period 2 (Re-randomized patients):
Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 64.
Overall Number of Baseline Participants in 'Placebo' arm is 30 (re-randomized) and 59 (all placebo).

Period 3 (Re-randomized patients):
Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 28.
Overall Number of Baseline Participants in 'Placebo' arm is is 30 (re-randomized) and 82 (all placebo).

Data for Period 1.
Period 2 & 3 are as follows:
Period 2, Re-randomized patients
Female: 19 participants in 'Trimethobenzamide (Tigan®)' arm and 11 participants in 'Placebo' arm.
Male: 45 participants in 'Trimethobenzamide (Tigan®)' arm and 19 participants in 'Placebo' arm.
Period 3, Re-randomized patients
Female: 7 participants in 'Trimethobenzamide (Tigan®)' arm and 8 participants in 'Placebo' arm.
Male: 21 participants in 'Trimethobenzamide (Tigan®)' arm and 22 participants in 'Placebo' arm.

Sex: Female, Male

The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson's disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability.

Unified Parkinson's Disease Rating Scale (UPDRS) total score for Period 1

Part III (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.

UPDRS motor score for Period 1

UPDRS total score for Period 2

UPDRS motor score for Period 2

UPDRS total score for Period 3

UPDRS motor score for Period 3

Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1

Incidence of Nausea and/or Vomiting for Period 1

Incidence of Nausea and/or Vomiting for Period 2

Incidence of Nausea and/or Vomiting for Period 3

The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.

Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1

Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2

Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3

The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.

Subject Global Evaluation of Randomized Study Medication for Period 1

Subject Global Evaluation of Randomized Study Medication for Period 2

Subject Global Evaluation of Randomized Study Medication for Period 3

Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.

Median Time to 'on' for Visit 2/Period 1 Injection 1

Median Time to 'on' for Visit 2/Period 1 Injection 2

Median Time to 'on' for Visit 3/End of Period 1 Injection

Median Time to 'on' for Visit 4/End of Period 2 Injection

Median Time to 'on' for Visit 5/End of Period 3 Injection

Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3

Tigan:Placebo

Screening and Initial Randomization

Period 1: Days 1 to 28

Period 2: Days 29 to 56

Period 3: Days 57 to 84

Medical Director, Neurology

Parkinson's Disease

Tigan®

Barrow Neurological Movement Disorder Clinic

Mayo Clinic

Coastal Neurological Medical Group Inc.

Neurosearch, Inc.

Neurosearch II, Inc.

Parkinson's Disease and Movement Disorders Center of Boca Raton

Neurology at Shands Medical Center

University of Florida at Jacksonville

Neurology Associates of Ormond Beach

Charlotte Neurological Services

Suncoast Neuroscience Associates, Inc.

USF Parkinson's Disease and Movement Disorders Center of Excellence

Emory University

NorthShore University Health System

Iowa Health Physicians

Parkinson's & Movements Disorders Center of Maryland

Quest Research Institute

Henry Ford Health System - Franklin Point

Parkinson's Disease and Movement Disorders Center of Long Island

Kingston Neurological Associates

Raleigh Neurology Associates

Neurological Institute, Cleveland Clinic

Neurology Specialist of Dallas P.A

Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine

Neurology Associates, P.A.

East Texas Medical Center

Sentara Neurological Associates

Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo

apomorphine/повръщане

Blinking and Yawning in Epilepsy: The Role of Dopamine

Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment

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