Clinical trial · Interventional
Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery
Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)
NCT00571155CI-TRIAL-00002560completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
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 |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
| Primary Brain Tumor | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| levetiracetam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: levetiracetam
Primary outcomes (1)
- measure
- Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * suspected primary brain tumor by imaging * planned bioptical or cytoreductive surgery of the tumor * symptomatic epilepsy * Karnofsky performance score ≥ 70% * women with child bearing potential must perform sufficient contraception * sufficient haematologic, hepatic and renal function by laboratory testing Exclusion Criteria: * treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery * known allergic reaction to levetiracetam or other serious side effects * known, not tumor-induced, epilepsy * previous brain surgery * dementia * participation in another clinical trial * addiction to drugs or alcohol * pregnant or breast feeding women
References
Publications (1)
- DERIVEDBahr O, Hermisson M, Rona S, Rieger J, Nussbaum S, Kortvelyessy P, Franz K, Tatagiba M, Seifert V, Weller M, Steinbach JP. Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial. Acta Neurochir (Wien). 2012 Feb;154(2):229-35; discussion 235. doi: 10.1007/s00701-011-1144-9. Epub 2011 Sep 10. PMID 21909835