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

Primary Purpose

Brain and Central Nervous System Tumors, Seizure

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

levetiracetam

pregabalin

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring seizure, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pineal gland astrocytoma, adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, adult brain stem glioma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult ependymoma, adult anaplastic ependymoma, adult anaplastic meningioma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult pineoblastoma, adult pineocytoma, adult mixed glioma, adult papillary meningioma, recurrent adult brain tumor, adult grade II meningioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire Vaudois
USZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Levetiracetam

Pregabalin

Arm Description

Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year

Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events

Anxiety

Need to add a second AED

Study drug discontinuation

Occurrence of consciousness-impairing seizures or status epilepticus

Mortality

Full Information

NCT ID

NCT00629889

First Posted

March 5, 2008

Last Updated

May 21, 2013

Sponsor

Dr Andrea Rossetti

1. Study Identification

Unique Protocol Identification Number

NCT00629889

Brief Title

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

Official Title

Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Andrea Rossetti

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

OBJECTIVES: To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive levetiracetam. Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors, Seizure

Keywords

seizure, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pineal gland astrocytoma, adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, adult brain stem glioma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult ependymoma, adult anaplastic ependymoma, adult anaplastic meningioma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult pineoblastoma, adult pineocytoma, adult mixed glioma, adult papillary meningioma, recurrent adult brain tumor, adult grade II meningioma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levetiracetam

Arm Type

Active Comparator

Arm Description

Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year

Arm Title

Pregabalin

Arm Type

Active Comparator

Arm Description

Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year

Intervention Type

Drug

Intervention Name(s)

levetiracetam

Intervention Description

After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.

Intervention Type

Drug

Intervention Name(s)

pregabalin

Intervention Description

After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.

Primary Outcome Measure Information:

Title

Time Frame