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Anti-epileptic drug

Anticonvulsants for Subdural Hematoma (GENESIS Trial)

Phase 4

Recruiting

Led By Christian Iorio-Morin, MD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of chronic subdural hematoma

Be aged ≥ 18 years

Must not have

Refusal of the attending physician

Presence of intracranial pathology not caused by subdural hematoma (intra-parenchymal hemorrhage, neoplasia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Summary

This trial will 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).

Who is the study for?

Adults over 18 with chronic subdural hematomas and short-term neurological symptoms, who haven't had positive results from standard seizure medications. Participants must not have glaucoma, be on other antiepileptic drugs, or have a history of severe reactions to the trial drugs. Pregnant individuals or those unable to follow up are excluded.

What is being tested?

The study is testing Topiramate (Topamax) against Levetiracetam in patients with different risks for cortical depression versus epileptic discharges. The goal is to see which drug better treats transient neurological symptoms associated with chronic subdural hematomas.

What are the potential side effects?

Possible side effects include dizziness, fatigue, confusion, speech problems for Topiramate; and sleepiness, weakness, behavioral changes for Levetiracetam. Both can potentially cause more serious adverse reactions in rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic subdural hematoma.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor has advised against me joining the trial.

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I do not have brain bleeding or tumors unrelated to subdural hematoma.

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I have had epilepsy or a seizure before my current brain bleed.

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I am currently on medication for epilepsy.

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I have glaucoma.

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I cannot take Topiramate due to health reasons.

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I cannot take Levetiracetam due to adverse reactions or health reasons.

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I have had kidney stones in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Between-group difference in the number of TNS reported at 6 month in participants with a positive Nonepileptic, Stereotyped, Intermittent Symptoms (NESIS) score (4 and more)

Secondary study objectives

Between-group difference in the number of TNS reported at 6 month in all participants (all NESIS scores)

Incidence of cortical spreading depression on electrocorticography in the first postoperative week of patients with preoperative TNS.

Side effects data

From 2007 Phase 1 trial • 32 Patients • NCT02283814

88%

Somnolence

50%

Paraesthesia oral

44%

Headache

31%

Dizziness

31%

Fatigue

31%

Lip dry

25%

Constipation

25%

Disturbance in attention

25%

Euphoric mood

19%

Back pain

19%

hot flush

13%

Vessel puncture site bruise

13%

Mood altered

13%

Psychomotor retardation

13%

Pharyngolaryngeal pain

13%

Rash

13%

Feeling hot

13%

Rash maculo-papular

13%

Feeling drunk

13%

Flatulence

Dysarthria

Speech disorder

Ocular hyperaemia

Abdominal distension

Paraesthesia

Vision blurred

Irritability

Tongue coated

dry eye

hypoaesthesia teeth

Reflux gastritis

Injury

Alanine aminotransferase increased

Arthalgia

Limb discomfort

Musculoskeletal pain

Muscular weakness

Libido increased

Dysuria

Pollakiuria

Epistaxis

Nasal congestion

Upper repiratory tract infection

Viral upper respiratory tract infection

Dry skin

Pruritus

Rash generalised

Venipuncture site redness

Abdominal pain upper

Diarrheoa

Pyrexia

Coordination abnormal

Head discomfort

Aspartate aminotransferase increased

Red blood cells urine positive

Decreased appetite

Myalgia

Sensation of heaviness

Palpitations

Erection increased

100%

80%

60%

40%

20%

Study treatment Arm

Group A BIA 2-093 + Topamax

Group B BIA 2-093 + Topamax

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Non-NESIS - TopiramateExperimental Treatment1 Intervention

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.

Group II: NESIS - TopiramateExperimental Treatment1 Intervention

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.

Group III: Non NESIS - LevetiracetamActive Control1 Intervention

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.

Group IV: NESIS - LevetiracetamActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topiramate

FDA approved

0 / 10Eligibility criteria met