search
Back to results

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

Primary Purpose

Chronic Subdural Hematoma, Epilepsy; Seizure, Cortical Depression; Cortical Depolarization

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Topamax
Levetiracetam
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Transient neurological symptoms, Levetiracetam; keppra, Lamotrigine; lamictal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be aged ≥ 18 years
  • Chronic subdural hematoma
  • Transient neurological symptoms (Sensory, motor, cerebellar or speech symptoms, lasting 6 hours or less)
  • Initial negative EEG

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Centre Hospitalier Universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

NESIS - Levetiracetam

NESIS - Topiramate

Non NESIS - Levetiracetam

Non-NESIS - Topiramate

Arm Description

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.

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.

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.

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.

Outcomes

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)
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 27, 2020
Last Updated
April 27, 2021
Sponsor
Université de Sherbrooke
search

1. Study Identification

Unique Protocol Identification Number
NCT04759196
Brief Title
Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
Acronym
GENESIS
Official Title
Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma, Epilepsy; Seizure, Cortical Depression; Cortical Depolarization, Nonepileptic, Stereotypical and Intermittent Symptoms, NESIS
Keywords
Transient neurological symptoms, Levetiracetam; keppra, Lamotrigine; lamictal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Masking Description
The participant will not know the medication they are taking. When accepting to participate, they are going to have the full list of possible side effects, without knowing which one are link to which medication. The doctors in charge of administering the questionnaires will be blind. The person in charge of analyzing the results will also be blind.
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NESIS - Levetiracetam
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NESIS - Topiramate
Arm Type
Experimental
Arm Description
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.
Arm Title
Non NESIS - Levetiracetam
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-NESIS - Topiramate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Topamax
Other Intervention Name(s)
Topiramate, TPM
Intervention Description
TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
LEV, Keppra
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Between-group difference in the number of TNS reported at 6 month in all participants (all NESIS scores)
Description
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.
Time Frame
Through study completion, an average of 3 years
Title
Incidence of cortical spreading depression on electrocorticography in the first postoperative week of patients with preoperative TNS.
Description
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.
Time Frame
Through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be aged ≥ 18 years Chronic subdural hematoma Transient neurological symptoms (Sensory, motor, cerebellar or speech symptoms, lasting 6 hours or less) Initial negative EEG Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
suzie adam, MD
Phone
5146990518
Email
suzie.adam@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Lévesque, MD
Email
Levesque@neurorivesud.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Iorio-Morin, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Iorio-Morin, MD, PhD
Email
christian.iorio-morin@usherbrooke.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11424031
Citation
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.
Results Reference
background
PubMed Identifier
28156246
Citation
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.
Results Reference
background
PubMed Identifier
28213197
Citation
Won 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.
Results Reference
background
PubMed Identifier
9759742
Citation
King 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.
Results Reference
background
PubMed Identifier
31555809
Citation
Levesque 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.
Results Reference
background
PubMed Identifier
23446683
Citation
Woitzik 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.
Results Reference
background
PubMed Identifier
29673289
Citation
Klass 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.
Results Reference
background
PubMed Identifier
31046659
Citation
Harriott 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.
Results Reference
background
PubMed Identifier
10768292
Citation
Shank 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.
Results Reference
background
PubMed Identifier
26935348
Citation
Bagnato 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.
Results Reference
background
PubMed Identifier
18713156
Citation
Ashtari 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.
Results Reference
background
PubMed Identifier
11903524
Citation
Storey 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.
Results Reference
background
PubMed Identifier
14982912
Citation
Brandes 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.
Results Reference
background
PubMed Identifier
18264012
Citation
Millan-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.
Results Reference
background
PubMed Identifier
15316798
Citation
Diener 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.
Results Reference
background
PubMed Identifier
15624081
Citation
Mei D, Capuano A, Vollono C, Evangelista M, Ferraro D, Tonali P, Di Trapani G. Topiramate in migraine prophylaxis: a randomised double-blind versus placebo study. Neurol Sci. 2004 Dec;25(5):245-50. doi: 10.1007/s10072-004-0350-0.
Results Reference
background
PubMed Identifier
15096395
Citation
Silberstein SD, Neto W, Schmitt J, Jacobs D; MIGR-001 Study Group. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004 Apr;61(4):490-5. doi: 10.1001/archneur.61.4.490.
Results Reference
background
PubMed Identifier
17371357
Citation
Gupta P, Singh S, Goyal V, Shukla G, Behari M. Low-dose topiramate versus lamotrigine in migraine prophylaxis (the Lotolamp study). Headache. 2007 Mar;47(3):402-12. doi: 10.1111/j.1526-4610.2006.00599.x.
Results Reference
background
PubMed Identifier
21059626
Citation
Beran RG, Spira PJ. Levetiracetam in chronic daily headache: a double-blind, randomised placebo-controlled study. (The Australian KEPPRA Headache Trial [AUS-KHT]). Cephalalgia. 2011 Apr;31(5):530-6. doi: 10.1177/0333102410384886. Epub 2010 Nov 8.
Results Reference
background
PubMed Identifier
23797674
Citation
Linde M, Mulleners WM, Chronicle EP, McCrory DC. Antiepileptics other than gabapentin, pregabalin, topiramate, and valproate for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010608. doi: 10.1002/14651858.CD010608.
Results Reference
background
PubMed Identifier
22523186
Citation
Unekawa M, Tomita Y, Toriumi H, Suzuki N. Suppressive effect of chronic peroral topiramate on potassium-induced cortical spreading depression in rats. Cephalalgia. 2012 May;32(7):518-27. doi: 10.1177/0333102412444015. Epub 2012 Apr 20.
Results Reference
background
PubMed Identifier
16056144
Citation
Akerman S, Goadsby PJ. Topiramate inhibits cortical spreading depression in rat and cat: impact in migraine aura. Neuroreport. 2005 Aug 22;16(12):1383-7. doi: 10.1097/01.wnr.0000175250.33159.a9.
Results Reference
background
PubMed Identifier
16450381
Citation
Ayata C, Jin H, Kudo C, Dalkara T, Moskowitz MA. Suppression of cortical spreading depression in migraine prophylaxis. Ann Neurol. 2006 Apr;59(4):652-61. doi: 10.1002/ana.20778.
Results Reference
background
PubMed Identifier
28928441
Citation
Lin CH, Hsu SP, Cheng TC, Huang CW, Chiang YC, Hsiao IH, Lee MH, Shen ML, Wu DC, Zhou N. Effects of anti-epileptic drugs on spreading depolarization-induced epileptiform activity in mouse hippocampal slices. Sci Rep. 2017 Sep 19;7(1):11884. doi: 10.1038/s41598-017-12346-y.
Results Reference
background
PubMed Identifier
30921021
Citation
Abou-Khalil BW. Update on Antiepileptic Drugs 2019. Continuum (Minneap Minn). 2019 Apr;25(2):508-536. doi: 10.1212/CON.0000000000000715.
Results Reference
background
PubMed Identifier
28566726
Citation
Zhuo C, Jiang R, Li G, Shao M, Chen C, Chen G, Tian H, Li J, Xue R, Jiang D. Efficacy and Tolerability of Second and Third Generation Anti-epileptic Drugs in Refractory Epilepsy: A Network Meta-Analysis. Sci Rep. 2017 May 31;7(1):2535. doi: 10.1038/s41598-017-02525-2.
Results Reference
background
Links:
URL
https://www.uptodate.com/contents/topiramate-drug-information?search=topiramate&usage_type=panel&kp_tab=drug_general&source=panel_search_result&selectedTitle=1~148&display_rank=1
Description
Topiramate. Drug information.
URL
https://www.uptodate.com/contents/levetiracetam-drug-information?search=keppra&source=panel_search_result&selectedTitle=1~82&usage_type=panel&kp_tab=drug_general&display_rank=1
Description
Levetiracetam. Drug information.
URL
https://hpr-rps.hres.ca/details.php?drugproductid=636&query=APO-TOPIRAMATE
Description
Santé canada, registres des produits pharmaceutiques. (Canadian drugs register)
URL
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
Description
Side effects classification

Learn more about this trial

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

We'll reach out to this number within 24 hrs