Clinical trial · Interventional
Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors
Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Seizure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| levetiracetam | Drug | — | UNRESOLVED |
| pregabalin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Levetiracetam
- description
- Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year
- interventionNames
- Drug: pregabalin
- type
- ACTIVE_COMPARATOR
- label
- Pregabalin
- description
- Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year
- interventionNames
- Drug: levetiracetam
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available