Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

Brain Tumor Clinical Trial

— LeviTaTe Pilot  

Official title:

Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897658
• Other study ID #: 14147
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Taylor Duda, MD
• Phone: 905-521-2100
• Email: taylor.duda[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult age 18 years or older
• Undergoing craniotomy for a brain tumor
• Intra-axial tumor location
• Supratentorial tumor location

Exclusion Criteria:

• Documented seizure history or epilepsy diagnosis
• Currently taking an antiepileptic medication
• Unable to take levetiracetam (e.g. allergy, inability to swallow)
• Inability to obtain consent from participant or substitute decision maker prior to surgery
• Renal impairment with eGFR less than 50
• Pregnancy

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Seizures

Intervention

Drug:
• Levetiracetam
Tablets

Other:
• Placebo
Tablets

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New onset seizure within 7 days of surgery		7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14
Other	Incidence of infection during Study Drug administration		Follow-up between post-operative day 8 and 14
Other	Incidence of psychiatric symptoms during Study Drug Administration		Follow-up between post-operative day 8 and 14
Other	Length of hospital stay in days		Hospital discharge
Other	Incidence of administration of any antiepileptic drugs		Follow-up between post-operative day 8 and 14
Other	Incidence of administration of any benzodiazepines		Follow-up between post-operative day 8 and 14
Primary	Recruitment Rate	Feasibility outcome	Through study completion, approximately 1 year
Secondary	Fraction of eligible patients approached		Through study completion, approximately 1 year
Secondary	Fraction of approached patients consent		Through study completion, approximately 1 year
Secondary	Role of individual who approached patients	Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)	Through study completion, approximately 1 year
Secondary	Protocol adherence	Number of participants who withdrawal from the study	Through study completion, approximately 1 year
Secondary	Protocol adherence	Drug adherence rate	Through study completion, approximately 1 year
Secondary	Protocol adherence	Follow-up completion rate	Through study completion, approximately 1 year
Secondary	Protocol adherence	Method of follow-up (e.g. telephone, clinic visit)	Through study completion, approximately 1 year
Secondary	Adverse events	Serious and related adverse events and adverse drug reactions	Through study completion, approximately 1 year
Secondary	Unblinding events	Number of events and reasoning	Through study completion, approximately 1 year