Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 40 for:    CARBAMAZEPINE AND Valproic Acid

Electroclinical Effect of Diazepam and Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490487
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Khalaf A Sayed, Assiut University

Brief Summary:
Benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in children. It is known to be age-dependent and presumably genetic. Age of onset ranges from one to fourteen years and it represents fifteen percent to twenty five percent of epilepsy in children under 15 years of age.

Condition or disease Intervention/treatment Phase
Benign Childhood Epilepsy With Centrotemporal Spikes Drug: conventional antiepileptic drugs Drug: oral steroid Drug: Diazepam Phase 4

Detailed Description:

Generally, Benign epilepsy with centro-temporal spikes is characterized by infrequent focal sensorimotor seizures in the face during sleep, which may secondarily generalize, along with spike-wave discharges, reflecting nonlesional cortical excitability from rolandic regions.

The prognosis is usually considered to be excellent. Over the past years, however, some investigators have questioned whether Benign epilepsy with centro-temporal spikes is indeed benign, considering the variety of different presentations associated with the disorder.It is not uncommon for Benign epilepsy with centro-temporal spikes to be associated with neuropsychological deficits, such as linguistic, cognitive, and behavioral impairment. In particular, reading difficulties and speech/language disorders are more common in children with Benign epilepsy with centro-temporal spikes than in healthy controls.Various neuropsychological deficits seem to be very dependent on the spike index, as well as the predominant localization of epileptiform discharges.Furthermore, the frequency of epileptiform discharges is closely related not only to the degree of neuropsychological deficits, but also to an atypical evolution of benign epilepsy with centro-temporal spikes.

The high comorbid prevalence of attention deficit hyperactivity disorder and epilepsy suggests that there is a bidirectional relationship between these disorders .Cognitive impairment and attention problems are particularly crucial issues in children with epilepsy who are in a vigorous phase of neurodevelopment.

Resolution of continuous spike-and-wave during sleep had been achieved with conventional antiepileptic drugs including ethosuximide, valproic acid, levetiracetam, and sulthiame. When these agents fail to normalize the EEG, a trial with second-line agents such as steroids or high-dose diazepam is attempted.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electroclinical Effect of Diazepam and Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes
Estimated Study Start Date : April 20, 2018
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Diazepam

Arm Intervention/treatment
Active Comparator: A antiepileptic
will receive conventional antiepileptic drugs only
Drug: conventional antiepileptic drugs
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: carbamazepine, valproate, oxcarbazepine or levetiracetam

Experimental: B steroid
will receive oral steroid for 3 months beside conventional antiepileptic drugs
Drug: conventional antiepileptic drugs
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: carbamazepine, valproate, oxcarbazepine or levetiracetam

Drug: oral steroid
will receive oral steroid for 3 months beside conventional antiepileptic drugs. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: Prednisolone

Experimental: C diazepam
will receive oral diazepam for 3 months beside conventional antiepileptic drugs
Drug: conventional antiepileptic drugs
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: carbamazepine, valproate, oxcarbazepine or levetiracetam

Drug: Diazepam
will receive oral diazepam for 3 months beside conventional antiepileptic drugs. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: Valium

Experimental: D diazepam and oral steroid
will receive both oral diazepam and oral steroid for 3 months beside conventional antiepileptic drugs.
Drug: conventional antiepileptic drugs
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: carbamazepine, valproate, oxcarbazepine or levetiracetam

Drug: oral steroid
will receive oral steroid for 3 months beside conventional antiepileptic drugs. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: Prednisolone

Drug: Diazepam
will receive oral diazepam for 3 months beside conventional antiepileptic drugs. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Other Name: Valium




Primary Outcome Measures :
  1. To compare between the effect of oral steroids and diazepam regarding normalization of sleep EEG. [ Time Frame: 3 months ]
    follow up Electroencephalography and calculation of spike-wave index before and after three months of treatment with diazepam and steroid.Any reduction in spike wave index on electroencephalograph after receiving diazepam or steroid will be considered improvement.The EEG technicians will be requested to perform a prolonged daytime nap EEG. The researcher first will look at the full sleep recording and visually pick the epoch with the highest spike density. The counting start with a page of a high spike density and continued for 10 consecutive minutes. Each page will be scored separately. Each second which contained spikes, either focal or generalized, will be considered positive, and the total number of positive seconds per page will be calculated as percents of the whole page. At the end of the counting, an average of 60 pages (10 min) will be performed and then displayed in terms of the nearest ten percentile number.

  2. To compare between the effect of oral steroids and diazepam regarding improvement of cognitive functions of patients with BECTS. [ Time Frame: 3 months ]
    Intelligence quotient assessment with Stanford-Binet scales will be done before and after three months of treatment with diazepam and steroid.Stanford-Binet Intelligence Scale (Fourth Edition) score: very superior (140 and above), superior (120-139), high average (110-119), normal average (90-109), low average (80-89), borderline defective (70-79), mentally defective (30-69). Higher scores will be considered a better or outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History and EEG findings of benign epilepsy with centrotemporal spikes

Exclusion Criteria:

  • Genetic disorders.
  • Metabolic or neurodegenerative disease.
  • Gross motor delay.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490487


Contacts
Layout table for location contacts
Contact: Gamal A Abdelal, MD +201111686162 Gamal.asker@med.au.edu.eg
Contact: Nafisa H Rifaat, MD +201003472082 nrefat@aun.edu.eg

Sponsors and Collaborators
Assiut University

Publications:

Layout table for additonal information
Responsible Party: Khalaf A Sayed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03490487     History of Changes
Other Study ID Numbers: DS
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes
Diazepam
Anticonvulsants
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Peripheral Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents