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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629889
• Other study ID #: CDR0000586523
• Secondary ID: CHUV-Neurology-C
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2008
• Last updated: May 21, 2013
• Start date: February 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Nervous System Neoplasms
• Seizure
• Seizures

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	USZ	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Dr Andrea Rossetti

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		baseline to visit at 12 months	Yes
Secondary	Adverse events		baseline to visit at 12 months	Yes
Secondary	Anxiety		baseline to visit at 12 months	No
Secondary	Need to add a second AED		baseline to visit at 12 months	No
Secondary	Study drug discontinuation		baseline to visit at 12 months	No
Secondary	Occurrence of consciousness-impairing seizures or status epilepticus		baseline to visit at 12 months	No
Secondary	Mortality		baseline to visit at 12 months	Yes