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

Tracking Information

First Received Date ^ICMJE

March 5, 2008

Last Updated Date

May 9, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00629889 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Designated as safety issue: Yes ]
Anxiety [ Designated as safety issue: No ]
Need to add a second AED [ Designated as safety issue: No ]
Study drug discontinuation [ Designated as safety issue: No ]
Occurrence of consciousness-impairing seizures or status epilepticus [ Designated as safety issue: No ]
Mortality [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label

Condition ^ICMJE

Brain and Central Nervous System Tumors
Seizure

Intervention ^ICMJE

Drug: levetiracetam
Drug: pregabalin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00629889

Responsible Party

Study ID Numbers ^ICMJE

CDR0000586523, CHUV-Neurology-CePO-LEV/PGB, EU-20807

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire Vaudois

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Andrea O. Rossetti, MD

Centre Hospitalier Universitaire Vaudois

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP