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Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

NCT04759196 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-04-30

No results posted yet for this study

Summary

Some patients with chronic subdural hematomas and transient neurological symptoms do not respond to standard antiepileptic drugs. The investigators think that some of them could have cortical depression rather than epileptic discharges. After an intensive literature review, the investigators found out that some antiepileptic dugs (Lamotrigine, Topiramate) were found to be efficient to treat cortical depression in other conditions (migraine, subarachnoid hemorrhage). In contrast, some other drugs (Levetiracetam) were not proved to be efficient. Knowing that, the investigators want to compare the efficacy of Topiramate against Levetiracetam in two different groups, the NESIS group (based on a NESIS score of 4 or more - increased risk of cortical depression) versus a non-NESIS group (score of 3 or less - increased risk of epileptic discharges).

Conditions

  • Chronic Subdural Hematoma
  • Epilepsy; Seizure
  • Cortical Depression; Cortical Depolarization
  • Nonepileptic, Stereotypical and Intermittent Symptoms
  • NESIS

Interventions

DRUG

Topamax

TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.

DRUG

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.

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Christian Iorio-Morin, MD · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759196 on ClinicalTrials.gov