Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery

NCT00571155 | Completed Phase 4

• 2 other identifiers: HELLO-Study 2007EudraCT Number: 2007-005063-96
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary Brain Tumor; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.

  1 year

Secondary Outcomes (1)

• Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.

  1 year

Study Arms (1)

1

OTHER

Drug: levetiracetam

Interventions

levetiracetam DRUG

oral and intravenous dosing 2000-3000 mg per day

Also known as: Keppra

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Department of General Neurology

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

• Bahr 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 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Epilepsy

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Weller, MD

  University-Hospital of Tuebingen, Department of General Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 20, 2009

Record last verified: 2009-08

Locations

DE (1)