Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Dr Andrea Rossetti
Information provided by (Responsible Party):
Dr Andrea Rossetti, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00629889
First received: March 5, 2008
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Seizure |
Drug: levetiracetam Drug: pregabalin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study. |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Centre Hospitalier Universitaire Vaudois:
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 [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: Yes ]
- Anxiety [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
- Need to add a second AED [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
- Study drug discontinuation [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
- Occurrence of consciousness-impairing seizures or status epilepticus [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Levetiracetam
Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year
|
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. |
|
Active Comparator: Pregabalin
Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year
|
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629889
Locations
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| USZ | |
| Zürich, Switzerland, CH-8091 | |
Sponsors and Collaborators
Dr Andrea Rossetti
Investigators
| Principal Investigator: | Andrea O. Rossetti, MD | Centre Hospitalier Universitaire Vaudois |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Andrea Rossetti, Médecin associé, Centre Hospitalier Universitaire Vaudois |
| ClinicalTrials.gov Identifier: | NCT00629889 History of Changes |
| Other Study ID Numbers: | CDR0000586523, CHUV-Neurology-CePO-LEV-PGB, EU-20807 |
| Study First Received: | March 5, 2008 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Centre Hospitalier Universitaire Vaudois:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Nervous System Neoplasms Seizures Central Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsy Neurologic Manifestations Signs and Symptoms Etiracetam |
Pregabalin Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013