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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights
GENESIS Trial 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.Check my eligibility
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.See study design
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.
GENESIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic subdural hematoma.
Select...
I am 18 years old or older.
GENESIS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 • NCT0228381488%
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
6%
Ocular hyperaemia
6%
Dysarthria
6%
Paraesthesia
6%
Speech disorder
6%
Abdominal distension
6%
Irritability
6%
Vision blurred
6%
Tongue coated
6%
dry eye
6%
hypoaesthesia teeth
6%
Reflux gastritis
6%
Injury
6%
Alanine aminotransferase increased
6%
Arthalgia
6%
Limb discomfort
6%
Musculoskeletal pain
6%
Muscular weakness
6%
Libido increased
6%
Dysuria
6%
Pollakiuria
6%
Epistaxis
6%
Nasal congestion
6%
Upper repiratory tract infection
6%
Viral upper respiratory tract infection
6%
Dry skin
6%
Pruritus
6%
Rash generalised
6%
Venipuncture site redness
6%
Abdominal pain upper
6%
Diarrheoa
6%
Pyrexia
6%
Coordination abnormal
6%
Head discomfort
6%
Aspartate aminotransferase increased
6%
Red blood cells urine positive
6%
Decreased appetite
6%
Myalgia
6%
Sensation of heaviness
6%
Palpitations
6%
Erection increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group A BIA 2-093 + Topamax
Group B BIA 2-093 + Topamax
GENESIS 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
Find a Location
Who is running the clinical trial?
Université de SherbrookeLead Sponsor
292 Previous Clinical Trials
69,385 Total Patients Enrolled
Christian Iorio-Morin, MDPrincipal InvestigatorUniversité de Sherbrooke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your first EEG test shows no abnormal brain activity.My doctor has advised against me joining the trial.I have been diagnosed with chronic subdural hematoma.I do not have brain bleeding or tumors unrelated to subdural hematoma.I have had epilepsy or a seizure before my current brain bleed.I am currently on medication for epilepsy.You have had a serious allergic reaction to LEV.You have had a bad reaction to TPM in the past.I have had brief episodes of numbness, weakness, coordination problems, or speech difficulties.I am 18 years old or older.I have glaucoma.I cannot take Topiramate due to health reasons.I cannot take Levetiracetam due to adverse reactions or health reasons.I have had kidney stones in the past.You have a history of major depression, psychosis, or risk of suicide.
Research Study Groups:
This trial has the following groups:- Group 1: Non-NESIS - Topiramate
- Group 2: Non NESIS - Levetiracetam
- Group 3: NESIS - Levetiracetam
- Group 4: NESIS - Topiramate
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies can be treated through the administration of Topamax?
"Topamax is widely used to treat tonic-clonic seizures, as well as lennox gastaut syndrome (LGS), type 2 diabetes mellitus and juvenile myoclonic epilepsy."
Answered by AI
What are the potential hazards associated with Topamax use?
"According to the team at Power, Topamax is rated a 3 on their safety scale. This rating reflects that this treatment has been approved following Phase 4 clinical trials."
Answered by AI
How many persons are being admitted to the experiment?
"Affirmative. According to the clinicaltrials.gov website, this therapeutic trial is actively seeking out participants and has been since March 1st 2021. The last update was made on April 27th 2021 with a goal of 56 patients at one medical centre."
Answered by AI
Is there still an opportunity to enrol in this investigation?
"Confirmed. According to clinicaltrials.gov, this research is currently open for recruitment; the first post was on March 1st 2021 and the most recent update occurred April 27th 2021."
Answered by AI
Are there any additional investigations involving Topamax?
"Currently, 35 clinical trials are underway for Topamax and 5 of those have reached the final stage. These research initiatives are mainly based in Brisbane, Queensland but span a total of 69 locations globally."
Answered by AI
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