Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery
This study has been completed.
Sponsor:
University Hospital Tuebingen
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00571155
First received: December 10, 2007
Last updated: August 19, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Brain Tumor Epilepsy |
Drug: levetiracetam |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: levetiracetam
oral and intravenous dosing 2000-3000 mg per day
Other Name: Keppra
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571155
Locations
| Germany | |
| University Hospital Tuebingen, Department of General Neurology | |
| Tuebingen, Baden-Wuerttemberg, Germany, 72076 | |
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
| Principal Investigator: | Michael Weller, MD | University-Hospital of Tuebingen, Department of General Neurology |
More Information
No publications provided by University Hospital Tuebingen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Michael Weller, University Hospital Tuebingen, Department of General Neurology |
| ClinicalTrials.gov Identifier: | NCT00571155 History of Changes |
| Other Study ID Numbers: | HELLO-Study 2007, EudraCT Number: 2007-005063-96 |
| Study First Received: | December 10, 2007 |
| Last Updated: | August 19, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Brain Neoplasms Epilepsy Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Etiracetam |
Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013