Chronic Subdural HematomaPhase 4GENESISNCT04759196
Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
A Phase 4 study testing Topamax and Levetiracetam in people with Chronic Subdural Hematoma and Epilepsy; Seizure, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Epilepsy; Seizure, Cortical Depression; Cortical Depolarization
- What is being tested?
- Topamax and Levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged ≥ 18 years
- Chronic subdural hematoma
- Transient neurological symptoms (Sensory, motor, cerebellar or speech symptoms, lasting 6 hours or less)
- Initial negative EEG
Who cannot join
- Contraindications to Levetiracetam
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mathieu Lévesque, MD contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Christian Iorio-Morin, MD, PhD, christian.iorio-morin@usherbrooke.ca
About this study
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).
Read the detailed description
Patients presenting with transient neurological symptoms in the context of subdural hemorrhage may present a diagnostic challenge. Many of these patients end up with a probable diagnosis of epilepsy (or acute symptomatic seizures), despite a negative electroencephalogram. The investigators believe that the origin of these transient neurologic symptoms in a significant subpopulation of these patients may in fact be cortical depolarization, rather than epileptiform activity. Very specific characteristics have already been identified that differentiate these patients from those who ultimately have epilepsy. The NESIS entity (nonepileptic, stereotypical, and intermittent symptoms) has been proposed to represent this group of patients. A NESIS score was then designed to help distinguish patients with epileptiform activity (confirmed by EEG) from those likely to have cortical depolarization. In other diseases presenting cortical depolarizations, certain antiepileptic treatments (including Topiramate) have already been recognized as effective. The investigators therefore want to perform a prospective, multicenter, randomized-controlled study (Topiramate group and Levetiracetam group) to determine whether a significant difference in the response to treatment exists between Topiramate and Levetiracetam in the NESIS group compared to the non-NESIS group. In addition, in a few eligible patients, the investigators will implant an electrocorticography electrode to demonstrate the existence of cortical depolarizations.
- Conditions
- Chronic Subdural Hematoma, Epilepsy; Seizure, Cortical Depression; Cortical Depolarization, Nonepileptic, Stereotypical and Intermittent Symptoms, NESIS
- Being tested
- Topamax, Levetiracetam
- Keywords
- Transient neurological symptoms, Levetiracetam; keppra, Lamotrigine; lamictal
- Medical subject headings
- Hematoma, Subdural, Chronic, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopamaxDrug
Also called Topiramate, TPM
TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.
LevetiracetamDrug
Also called LEV, Keppra
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.
| Study group | Role | What they receive |
|---|---|---|
| NESIS - Levetiracetam | Active comparator | 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. Receives: Drug: Levetiracetam |
| NESIS - Topiramate | Experimental | 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. Receives: Drug: Topamax |
| Non NESIS - Levetiracetam | Active comparator | 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. Receives: Drug: Levetiracetam |
| Non-NESIS - Topiramate | Experimental | 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. Receives: Drug: Topamax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
The aim of this study is to demonstrate the efficacy of Topiramate in the treatment of patients with transient neurological symptoms in the context of chronic subdural hemorrhage with a positive NESIS score (4 and more), in whom usual epilepsy treatment appears to be less effective. To do this, the effect of Topiramate (shown to be effective in cortical depressions) will be compared with that of Levetiracetam (which has not been shown to be effective in cortical depressions). This is going to be done by a questionnaire that will assess the resolution of symptoms or not, or the percentage of diminution.
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
Between-group difference in the number of TNS reported at 6 month in all participants (all NESIS scores)
If the investigators manage to demonstrate a significant difference between the response to TPM and LEV in the NESIS group compared to the non-NESIS group with our questionnaire, the evidence concerning the existence of a different process at the origin of the NESIS group will then be more numerous. As demonstrated in studies on rats, cortical spreading depolarization respond well to TPM and not to LEV. Cortical depolarizations will then be the main hypothesis of the reason why some responds better to TPM than LEV in our study.
Measured: Through study completion, an average of 3 years
Incidence of cortical spreading depression on electrocorticography in the first postoperative week of patients with preoperative TNS.
The investigators think that cortical depression rather then epileptic discharges could be involved in some patients with transient neurological symptoms in context of subdural hematomas. Some participant could need decompression surgery for their subdural hematoma. The investigators will offer the insertion of electrocorticography electrods while this surgery. The aim of this intervention will be to prove cortical depression in some subjects by using electrocorticography that will be read by a neurologist specialized in epilepsy.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with chronic subdural hematomas, transient neurological symptoms with negative EEG will be divided in two groups based on their NESIS scores (up to 3 (increased risk of epileptic seizures) and 4 or more (increased risk of cortical depression)). Those two groups are going to receive both Levetiracetam or Lamotrigine.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Iorio-Morin, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759196
- Sponsor's protocol ID
- MP-31-2021-3687
- Acronym
- GENESIS
- Status last verified
- Apr 2021
- First submitted
- 27 Oct 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cousseau DH, Echevarria Martin G, Gaspari M, Gonorazky SE. [Chronic and subacute subdural haematoma. An epidemiological study in a captive population]. Rev Neurol. 2001 May 1-15;32(9):821-4. Spanish.
PubMed 11424031Toi 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.
PubMed 28156246Won SY, Dubinski D, Herrmann E, Cuca C, Strzelczyk A, Seifert V, Konczalla J, Freiman TM. Epileptic Seizures in Patients Following Surgical Treatment of Acute Subdural Hematoma-Incidence, Risk Factors, Patient Outcome, and Development of New Scoring System for Prophylactic Antiepileptic Treatment (GATE-24 score). World Neurosurg. 2017 May;101:416-424. doi: 10.1016/j.wneu.2017.02.024. Epub 2017 Feb 16.
PubMed 28213197King MA, Newton MR, Jackson GD, Fitt GJ, Mitchell LA, Silvapulle MJ, Berkovic SF. Epileptology of the first-seizure presentation: a clinical, electroencephalographic, and magnetic resonance imaging study of 300 consecutive patients. Lancet. 1998 Sep 26;352(9133):1007-11. doi: 10.1016/S0140-6736(98)03543-0.
PubMed 9759742Levesque M, Iorio-Morin C, Bocti C, Vezina C, Deacon C. Nonepileptic, Stereotypical, and Intermittent Symptoms (NESIS) in Patients With Subdural Hematoma: Proposal for a New Clinical Entity With Therapeutic and Prognostic Implications. Neurosurgery. 2020 Jul 1;87(1):96-103. doi: 10.1093/neuros/nyz355.
PubMed 31555809Woitzik J, Hecht N, Pinczolits A, Sandow N, Major S, Winkler MK, Weber-Carstens S, Dohmen C, Graf R, Strong AJ, Dreier JP, Vajkoczy P; COSBID study group. Propagation of cortical spreading depolarization in the human cortex after malignant stroke. Neurology. 2013 Mar 19;80(12):1095-102. doi: 10.1212/WNL.0b013e3182886932. Epub 2013 Feb 27.
PubMed 23446683Klass A, Sanchez-Porras R, Santos E. Systematic review of the pharmacological agents that have been tested against spreading depolarizations. J Cereb Blood Flow Metab. 2018 Jul;38(7):1149-1179. doi: 10.1177/0271678X18771440. Epub 2018 Apr 20.
PubMed 29673289Harriott AM, Takizawa T, Chung DY, Chen SP. Spreading depression as a preclinical model of migraine. J Headache Pain. 2019 May 2;20(1):45. doi: 10.1186/s10194-019-1001-4.
PubMed 31046659Shank RP, Gardocki JF, Streeter AJ, Maryanoff BE. An overview of the preclinical aspects of topiramate: pharmacology, pharmacokinetics, and mechanism of action. Epilepsia. 2000;41(S1):3-9.
PubMed 10768292Bagnato F, Good J. The Use of Antiepileptics in Migraine Prophylaxis. Headache. 2016 Mar;56(3):603-15. doi: 10.1111/head.12781. Epub 2016 Mar 3.
PubMed 26935348Ashtari F, Shaygannejad V, Akbari M. A double-blind, randomized trial of low-dose topiramate vs propranolol in migraine prophylaxis. Acta Neurol Scand. 2008 Nov;118(5):301-5. doi: 10.1111/j.1600-0404.2008.01087.x.
PubMed 18713156Storey JR, Calder CS, Hart DE, Potter DL. Topiramate in migraine prevention: a double-blind, placebo-controlled study. Headache. 2001 Nov-Dec;41(10):968-75. doi: 10.1046/j.1526-4610.2001.01190.x.
PubMed 11903524Brandes JL, Saper JR, Diamond M, Couch JR, Lewis DW, Schmitt J, Neto W, Schwabe S, Jacobs D; MIGR-002 Study Group. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004 Feb 25;291(8):965-73. doi: 10.1001/jama.291.8.965.
PubMed 14982912Millan-Guerrero RO, Isais-Millan R, Barreto-Vizcaino S, Gutierrez I, Rivera-Castano L, Trujillo-Hernandez B, Baltazar LM. Subcutaneous histamine versus topiramate in migraine prophylaxis: a double-blind study. Eur Neurol. 2008;59(5):237-42. doi: 10.1159/000115637. Epub 2008 Feb 8.
PubMed 18264012Diener HC, Tfelt-Hansen P, Dahlof C, Lainez MJ, Sandrini G, Wang SJ, Neto W, Vijapurkar U, Doyle A, Jacobs D; MIGR-003 Study Group. Topiramate in migraine prophylaxis--results from a placebo-controlled trial with propranolol as an active control. J Neurol. 2004 Aug;251(8):943-50. doi: 10.1007/s00415-004-0464-6.
PubMed 15316798
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
- ClinicalTrials.gov ID
- NCT04759196
- Acronym / sponsor ID
- GENESIS / MP-31-2021-3687
- Conditions
- Chronic Subdural Hematoma, Epilepsy; Seizure, Cortical Depression; Cortical Depolarization, Nonepileptic, Stereotypical and Intermittent Symptoms, NESIS
- Keywords
- Transient neurological symptoms, Levetiracetam; keppra, Lamotrigine; lamictal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients presenting with transient neurological symptoms in the context of subdural hemorrhage may present a diagnostic challenge. Many of these patients end up with a probable diagnosis of epilepsy (or acute symptomatic seizures), despite a negative electroencephalogram. The investigators believe that the origin of these transient neurologic symptoms in a significant subpopulation of these patients may in fact be cortical depolarization, rather than epileptiform activity. Very specific characteristics have already been identified that differentiate these patients from those who ultimately have epilepsy. The NESIS entity (nonepileptic, stereotypical, and intermittent symptoms) has been proposed to represent this group of patients. A NESIS score was then designed to help distinguish patients with epileptiform activity (confirmed by EEG) from those likely to have cortical depolarization. In other diseases presenting cortical depolarizations, certain antiepileptic treatments (including Topiramate) have already been recognized as effective. The investigators therefore want to perform a prospective, multicenter, randomized-controlled study (Topiramate group and Levetiracetam group) to determine whether a significant difference in the response to treatment exists between Topiramate and Levetiracetam in the NESIS group compared to the non-NESIS group. In addition, in a few eligible patients, the investigators will implant an electrocorticography electrode to demonstrate the existence of cortical depolarizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients with chronic subdural hematomas, transient neurological symptoms with negative EEG will be divided in two groups based on their NESIS scores (up to 3 (increased risk of epileptic seizures) and 4 or more (increased risk of cortical depression)). Those two groups are going to receive both Levetiracetam or Lamotrigine.
| Arm | Type | Receives |
|---|---|---|
| NESIS - Levetiracetam | Active comparator | Drug: LevetiracetamParticipant 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. |
| NESIS - Topiramate | Experimental | Drug: TopamaxParticipant 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. |
| Non NESIS - Levetiracetam | Active comparator | Drug: LevetiracetamParticipant 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. |
| Non-NESIS - Topiramate | Experimental | Drug: TopamaxParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged ≥ 18 years
- Chronic subdural hematoma
- Transient neurological symptoms (Sensory, motor, cerebellar or speech symptoms, lasting 6 hours or less)
- Initial negative EEG
Key exclusion criteria (13 listed)
- Contraindications to Levetiracetam
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopamaxAlso: Topiramate, TPMTPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID. | Drug | NESIS - Topiramate, Non-NESIS - Topiramate |
| LevetiracetamAlso: LEV, KeppraLEV : 500 mg BID, with increase of 1000 mg die divided in two doses each week until efficacy, to a maximum of 1500 mg BID. | Drug | NESIS - Levetiracetam, Non NESIS - Levetiracetam |
Primary outcome
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)
Time frame: Through study completion, an average of 3 years
The aim of this study is to demonstrate the efficacy of Topiramate in the treatment of patients with transient neurological symptoms in the context of chronic subdural hemorrhage with a positive NESIS score (4 and more), in whom usual epilepsy treatment appears to be less effective. To do this, the effect of Topiramate (shown to be effective in cortical depressions) will be compared with that of Levetiracetam (which has not been shown to be effective in cortical depressions). This is going to be done by a questionnaire that will assess the resolution of symptoms or not, or the percentage of diminution.
2 secondary outcomes
Between-group difference in the number of TNS reported at 6 month in all participants (all NESIS scores)
Time frame: Through study completion, an average of 3 years
Incidence of cortical spreading depression on electrocorticography in the first postoperative week of patients with preoperative TNS.
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 11424031Cousseau DH, Echevarria Martin G, Gaspari M, Gonorazky SE. [Chronic and subacute subdural haematoma. An epidemiological study in a captive population]. Rev Neurol. 2001 May 1-15;32(9):821-4. Spanish.
- Background: PubMed 28156246Toi 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.
- Background: PubMed 28213197Won SY, Dubinski D, Herrmann E, Cuca C, Strzelczyk A, Seifert V, Konczalla J, Freiman TM. Epileptic Seizures in Patients Following Surgical Treatment of Acute Subdural Hematoma-Incidence, Risk Factors, Patient Outcome, and Development of New Scoring System for Prophylactic Antiepileptic Treatment (GATE-24 score). World Neurosurg. 2017 May;101:416-424. doi: 10.1016/j.wneu.2017.02.024. Epub 2017 Feb 16.
- Background: PubMed 9759742King MA, Newton MR, Jackson GD, Fitt GJ, Mitchell LA, Silvapulle MJ, Berkovic SF. Epileptology of the first-seizure presentation: a clinical, electroencephalographic, and magnetic resonance imaging study of 300 consecutive patients. Lancet. 1998 Sep 26;352(9133):1007-11. doi: 10.1016/S0140-6736(98)03543-0.
- Background: PubMed 31555809Levesque M, Iorio-Morin C, Bocti C, Vezina C, Deacon C. Nonepileptic, Stereotypical, and Intermittent Symptoms (NESIS) in Patients With Subdural Hematoma: Proposal for a New Clinical Entity With Therapeutic and Prognostic Implications. Neurosurgery. 2020 Jul 1;87(1):96-103. doi: 10.1093/neuros/nyz355.
- Background: PubMed 23446683Woitzik J, Hecht N, Pinczolits A, Sandow N, Major S, Winkler MK, Weber-Carstens S, Dohmen C, Graf R, Strong AJ, Dreier JP, Vajkoczy P; COSBID study group. Propagation of cortical spreading depolarization in the human cortex after malignant stroke. Neurology. 2013 Mar 19;80(12):1095-102. doi: 10.1212/WNL.0b013e3182886932. Epub 2013 Feb 27.
- Background: PubMed 29673289Klass A, Sanchez-Porras R, Santos E. Systematic review of the pharmacological agents that have been tested against spreading depolarizations. J Cereb Blood Flow Metab. 2018 Jul;38(7):1149-1179. doi: 10.1177/0271678X18771440. Epub 2018 Apr 20.
- Background: PubMed 31046659Harriott AM, Takizawa T, Chung DY, Chen SP. Spreading depression as a preclinical model of migraine. J Headache Pain. 2019 May 2;20(1):45. doi: 10.1186/s10194-019-1001-4.
- Background: PubMed 10768292Shank RP, Gardocki JF, Streeter AJ, Maryanoff BE. An overview of the preclinical aspects of topiramate: pharmacology, pharmacokinetics, and mechanism of action. Epilepsia. 2000;41(S1):3-9.
- Background: PubMed 26935348Bagnato F, Good J. The Use of Antiepileptics in Migraine Prophylaxis. Headache. 2016 Mar;56(3):603-15. doi: 10.1111/head.12781. Epub 2016 Mar 3.
- Background: PubMed 18713156Ashtari F, Shaygannejad V, Akbari M. A double-blind, randomized trial of low-dose topiramate vs propranolol in migraine prophylaxis. Acta Neurol Scand. 2008 Nov;118(5):301-5. doi: 10.1111/j.1600-0404.2008.01087.x.
- Background: PubMed 11903524Storey JR, Calder CS, Hart DE, Potter DL. Topiramate in migraine prevention: a double-blind, placebo-controlled study. Headache. 2001 Nov-Dec;41(10):968-75. doi: 10.1046/j.1526-4610.2001.01190.x.
- Topiramate. Drug information.Link provided by the sponsor.
- Levetiracetam. Drug information.Link provided by the sponsor.
- Santé canada, registres des produits pharmaceutiques. (Canadian drugs register)Link provided by the sponsor.
- Side effects classificationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Lévesque, MD contact
Christian Iorio-Morin, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topamax and Levetiracetam in people with Chronic Subdural Hematoma and Epilepsy; Seizure, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suzie adam, MD (5146990518, suzie.adam@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759196, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.