Adverse Reaction to Drug

Allergic Reaction to Contrast Media

Gadoteric Acid

Saint Louis University

Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age

Assessment of Immediate Adverse Reactions in Children Under 2 Years of Age Following Administration of Gadoteric Acid (Gd-DOTA or Dotarem)

To assess whether lesion detection and characterization is improved with Dotarem compared to the noncontrast images.

Shannon G. Farmakis, M.D.

Assistant Professor

St. Louis University

61 participating subjects were randomized into 2 groups: 30 received metoclopramide up to 30 mg/day and 31 received placebo, each for 4 weeks in a double-blind mode

Clozapine-induced Hypersalivation

Metoclopramide

placebo

Be'er Sheva Mental Health Center,

Metoclopramide as Treatment of Clozapine-induced Hypersalivation

Vladimir Lerner

Prof. Vladimir Lerner

Beersheva Mental Health Center

Tirat Carmel Mental Health Center

0.25 mg/kg/day; tablets; orally; for 15-18 weeks

Clobazam Low Dose

0.5 mg/kg/day; tablets; orally; for 15-18 weeks

Clobazam Medium Dose

1.0 mg/kg/day; tablets; orally; for 15-18 weeks

Clobazam High Dose

Placebo

Total

Sex: Female, Male

Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.

Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).

Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).

Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).

Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).

Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.

Tolerance

The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".

Investigator Global Evaluations of the Patient's Overall Change in Symptoms.

The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.

This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.

Percent Reduction in the Number of Non-drop Seizures.

This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.

Percent Reduction of Total (Drop and Non-Drop) Seizures.

Overall Study

Email contact via H. Lundbeck A/S

Epilepsy

Epilepsy, Generalized

Seizures

University of Alabama at Birmingham

St. Joseph's Hospital and Medical Center

Phoenix Children's Hospital

Childrens Hospital Los Angeles

The Children's Hospital

Children's National Medical Center

Pediatric Neurology and Epilepsy Center

Child Neurology Center of NW FL

University of South Florida

Pediatric Epilepsy & Neurology Specialists

Medical College of Georgia

Pediatric Neurology of Idaho Children's Specialty Center

Rush University Medical Center

University of Chicago Medical Center

Children's Memorial Hospital

University of Kentucky, Kentucky Clinic, Department of Neurology

LSU Health Sciences Center

Mid-Atlantic Epilepsy and Sleep Center

Massachusetts General Hospital

Minnesota Epilepsy Group

The Comprehensive Epilepsy Care Center for Children and Adults

Dartmouth-Hitchcock Medical Center

Robert Wood Johnson University Hospital

St. Joseph's Regional Medical Center

Clinical Research Center of New Jersey (CRCNJ)

University of Rochester Medical Center

University Neurology, Inc.

The Children's Hospital of Philadelphia

Jefferson Epilepsy Center

UTMG Pediatric Neurology

Children's Medical Center at UT Southwestern-Dallas

Cook Children's Health Care System

Baylor College of Medicine Pediatric Neurology

Virginia Commonwealth University

Strategic Health Evaluators

Royal Melbourne Hospital Department of Neurology

Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre

Vitebsk Regional Diagnostic Center

Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre

Neurology Center

St. John's Medical College Hospital

Malikatta Neuro Center

K. S. Hedge Medical Academy

Jaslok Hospital & Research Centre

KEM Hospital & Research Centre

Institute of Human Behaviour and Allied Sciences

Deenanath Mangeshkar Hospital and Research Center

Christian Medical College

Dr. Kamakshi Memorial Hospital

Chhatrapati Sahu Ji Maharaj Medical University

Apollo Gleneagles Hospitals

P.D. Hinduja National Hospital Medical Research Centre

Kaunas University of Medicine Hospital

Clobazam in Patients With Lennox-Gastaut Syndrome

Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome

Lundbeck LLC

Epilepsy, Rolandic

topamax

Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

A Randomized, Open Label, Comparative, Multi-center Clinical Trial to Determine the Efficacy and Safety of Topiramate Comparing With Carbamazepine in Benign Rolandic Epilepsy.

Janssen Korea, Ltd., Korea

sialorrhea

napad padaczkowy

seizures

sialorrhea/napad padaczkowy

Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age

Metoclopramide as Treatment of Clozapine-induced Hypersalivation

Clobazam in Patients With Lennox-Gastaut Syndrome

Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

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