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

NCT ID: NCT00629889

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-05-31

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.

Conditions

Brain and Central Nervous System Tumors; Seizure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Levetiracetam

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

Group Type: ACTIVE_COMPARATOR

pregabalin

Intervention Type: DRUG

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.

Pregabalin

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

Group Type: ACTIVE_COMPARATOR

levetiracetam

Intervention Type: DRUG

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.

Interventions

levetiracetam

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

pregabalin

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Andrea Rossetti

OTHER

Sponsor Role: lead

Responsible Party

Dr Andrea Rossetti

Médecin associé

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrea O. Rossetti, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

USZ

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

CHUV-Neurology-CePO-LEV-PGB

Identifier Type: -

Identifier Source: secondary_id

EU-20807

Identifier Type: -

Identifier Source: secondary_id

CDR0000586523

Identifier Type: -

Identifier Source: org_study_id