1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

NCT02334722 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB201400876OCR14673
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.

Conditions

Brain Neoplasms; Brain Cancer; Brain Tumors; Cancer of the Brain; Cancer of Brain; Seizure

Outcome Measures

Primary Outcomes (1)

• Change in Neurotoxicity Scale Scores

  The Neurotoxicity Scale is as a validated 27 question, patient-reported measure for assessing the adverse effects of antiepileptic drugs on cognitive function. Patients self-report "no problem", "a mild problem", "a moderate problem" or "a serious problem" for each question corresponding to a score of 0, 1, 2, and 3, respectively. For each patient, the overall score was formed by summing scores in all 27 questions. The minimum possible score is 0 and the maximum possible total score is 81. A lower score indicates less toxicity when taking an antiepileptic drug. The outcome is a score change from baseline at the 6 week follow-up and is calculated by subtracting the baseline score from the 6 week follow-up score for each patient.

  Baseline to 6 weeks

Study Arms (2)

1 Week Levetiracetam

EXPERIMENTAL

Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Drug: Levetiracetam

6 Week Levetiracetam

ACTIVE COMPARATOR

Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Also known as: Keppra

1 Week Levetiracetam; 6 Week Levetiracetam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves.
• Able to be randomized prior to or up to 48 hours after surgery.

You may not qualify if:

• No known history of seizure activity.
• Pregnant or breastfeeding.
• Renal dysfunction (CrCl \< 30ml/min).
• Beck's Depression Inventory (BDI) ≥14
• Allergy to levetiracetam.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kristine Wynne
• Organization: University of Florida

kristine.wynne@neurosurgery.ufl.edu

352-273-9727

Study Officials

• Maryam Rahman, MS, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: August 5, 2015
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)