LeviTaTe Pilot: Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05897658
• Collaborator: McMaster University (Other)
• Enrollment: 70
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Seizures; Brain Tumor	Drug: Levetiracetam; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Seizure Prophylaxis (Levetiracetam) Levetiracetam 1 g taken orally twice a day for 7 days	Drug: Levetiracetam; Tablets
Placebo Comparator: Placebo Placebo taken orally twice a day for 7 days	Other: Placebo; Tablets

Outcome Measures

Primary Outcome Measures

1. Recruitment Rate [Through study completion, approximately 1 year]

   Feasibility outcome

Secondary Outcome Measures

1. Fraction of eligible patients approached [Through study completion, approximately 1 year]

2. Fraction of approached patients consent [Through study completion, approximately 1 year]

3. Role of individual who approached patients [Through study completion, approximately 1 year]

   Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)

4. Protocol adherence [Through study completion, approximately 1 year]

   Number of participants who withdrawal from the study

5. Protocol adherence [Through study completion, approximately 1 year]

   Drug adherence rate

6. Protocol adherence [Through study completion, approximately 1 year]

   Follow-up completion rate

7. Protocol adherence [Through study completion, approximately 1 year]

   Method of follow-up (e.g. telephone, clinic visit)

8. Adverse events [Through study completion, approximately 1 year]

   Serious and related adverse events and adverse drug reactions

9. Unblinding events [Through study completion, approximately 1 year]

   Number of events and reasoning

Other Outcome Measures

1. New onset seizure within 7 days of surgery [7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14]

2. Incidence of infection during Study Drug administration [Follow-up between post-operative day 8 and 14]

3. Incidence of psychiatric symptoms during Study Drug Administration [Follow-up between post-operative day 8 and 14]

4. Length of hospital stay in days [Hospital discharge]

5. Incidence of administration of any antiepileptic drugs [Follow-up between post-operative day 8 and 14]

6. Incidence of administration of any benzodiazepines [Follow-up between post-operative day 8 and 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hamilton Health Sciences Corporation
• McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamilton Health Sciences Corporation
• ClinicalTrials.gov Identifier: NCT05897658
• Other Study ID Numbers: 14147
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Neoplasms; Seizures; Levetiracetam

Study Results

No Results Posted as of Jun 9, 2023