Electroclinical Effect of Diazepam and Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes
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| ClinicalTrials.gov Identifier: NCT03490487 |
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Recruitment Status :
Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Benign Childhood Epilepsy With Centrotemporal Spikes | Drug: conventional antiepileptic drugs Drug: oral steroid Drug: Diazepam | Phase 4 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: A antiepileptic
will receive conventional antiepileptic drugs only
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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 |
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Experimental: B steroid
will receive oral steroid for 3 months beside conventional antiepileptic drugs
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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 |
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Experimental: C diazepam
will receive oral diazepam for 3 months beside conventional antiepileptic drugs
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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 |
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Experimental: D diazepam and oral steroid
will receive both oral diazepam and oral steroid for 3 months beside conventional antiepileptic drugs.
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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 |
- 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.
- 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.
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| Ages Eligible for Study: | 3 Years to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History and EEG findings of benign epilepsy with centrotemporal spikes
Exclusion Criteria:
- Genetic disorders.
- Metabolic or neurodegenerative disease.
- Gross motor delay.
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
| Contact: Gamal A Abdelal, MD | +201111686162 | Gamal.asker@med.au.edu.eg | |
| Contact: Nafisa H Rifaat, MD | +201003472082 | nrefat@aun.edu.eg |
Publications:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |