Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors

Dr Andrea Rossetti

Status and phase

Completed

Phase 2

Conditions

Seizure

Brain and Central Nervous System Tumors

Treatments

Drug: levetiracetam

Drug: pregabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT00629889

CDR0000586523

EU-20807

CHUV-Neurology-CePO-LEV-PGB

Details and patient eligibility

About

RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known which drug is more effective in treating seizures caused by primary brain tumors.

PURPOSE: This randomized phase II trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.

Full description

OBJECTIVES:

To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive levetiracetam.
Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of primary brain tumor
- WHO grade II-IV disease
Undergoing chemotherapy and/or radiotherapy
No brain tumor without the potential need for chemotherapy (e.g., meningioma without anaplastic features)
Has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (AED) treatment
- No status epilepticus

PATIENT CHARACTERISTICS:

Modified Rankin score < 4 at study enrollment
Life expectancy ≥ 4 weeks
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No known intolerance to the study drugs
No pre-existing psychosis and/or current suicidality

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent IV AEDs other than benzodiazepines
Other concurrent AEDs, except phenobarbital, allowed provided they are discontinued within 2 weeks after study enrollment