Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
NCT ID: NCT04759196
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
56 participants
INTERVENTIONAL
2021-03-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The doctors in charge of administering the questionnaires will be blind. The person in charge of analyzing the results will also be blind.
Study Groups
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NESIS - Levetiracetam
Participant with a score NESIS of 4 or more (increased risk of having cortical depression).
Levetiracetam is an anti-epileptic drug known to be inefficient in other condition with cortical depression. It will be use as an active comparator.
Levetiracetam
LEV : 500 mg BID, with increase of 1000 mg die divided in two doses each week until efficacy, to a maximum of 1500 mg BID.
NESIS - Topiramate
Participant with a score NESIS of 4 or more (increased risk of having cortical depression).
Topiramate is an anti-epileptic drug known to be efficient in other condition with cortical depression. The investigators want to test his efficacy in chronic subdural hematoma with probable cortical depression.
Topamax
TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.
Non NESIS - Levetiracetam
Participant with a score NESIS of 3 or less (increased risk of having epileptic discharges).
Levetiracetam is an anti-epileptic drug known to be inefficient in other condition with cortical depression. It will be use as an active comparator.
Levetiracetam should be as efficient as Topiramate in a group a participant with epileptic discharges.
Levetiracetam
LEV : 500 mg BID, with increase of 1000 mg die divided in two doses each week until efficacy, to a maximum of 1500 mg BID.
Non-NESIS - Topiramate
Participant with a score NESIS of 3 or less (increased risk of having epileptic discharges).
Topiramate is an anti-epileptic drug known to be efficient in other condition with cortical depression. The investigators want to test his efficacy in chronic subdural hematoma with probable cortical depression.
Topiramate should be as efficient as Levetiracetam in a group a participant with epileptic discharges.
Topamax
TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.
Interventions
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Topamax
TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.
Levetiracetam
LEV : 500 mg BID, with increase of 1000 mg die divided in two doses each week until efficacy, to a maximum of 1500 mg BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic subdural hematoma
* Transient neurological symptoms (Sensory, motor, cerebellar or speech symptoms, lasting 6 hours or less)
* Initial negative EEG
Exclusion Criteria
* Psychiatric history (major depression, psychosis, risk of suicide)
* History of hypersensitivity to LEV (anaphylaxis, angioedema, skin reaction)
* Contraindications to Topiramate
* History of hypersensitivity to TPM
* Glaucoma
* Past of nephrolithiasis
* Known epilepsy or past seizure before the current subdural hemorrhage
* Actual taking of an antiepileptic drug
* Intracranial pathology not caused by subdural hematoma (intra-parenchymal hemorrhage, neoplasia)
* Pregnancy or planning to
* Inability to carry out the necessary follow-ups for the study
* Refusal of the attending physician
18 Years
ALL
No
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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Principal Investigators
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Christian Iorio-Morin, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Christian Iorio-Morin, MD, PhD
Role: primary
References
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Toi H, Kinoshita K, Hirai S, Takai H, Hara K, Matsushita N, Matsubara S, Otani M, Muramatsu K, Matsuda S, Fushimi K, Uno M. Present epidemiology of chronic subdural hematoma in Japan: analysis of 63,358 cases recorded in a national administrative database. J Neurosurg. 2018 Jan;128(1):222-228. doi: 10.3171/2016.9.JNS16623. Epub 2017 Feb 3.
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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Topiramate. Drug information.
Levetiracetam. Drug information.
Santé canada, registres des produits pharmaceutiques. (Canadian drugs register)
Side effects classification
Other Identifiers
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MP-31-2021-3687
Identifier Type: -
Identifier Source: org_study_id