CompletedPhase 2

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

Switzerland52 participantsStarted 2008-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival without occurrence of status epilepticus, 2 seizures with consciousness impairment, need to add a second antiepileptic drug (AED) (except transitory benzodiazepine), and need to discontinue study drug for lack of efficacy or adverse events

Timeframe: baseline to visit at 12 months

Trial details

NCT IDNCT00629889

SponsorDr Andrea Rossetti

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Brain and Central Nervous System Tumors trials