Brain and Central Nervous System TumorsPhase 2NCT00629889
Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors
A Phase 2 study testing levetiracetam and pregabalin in people with Brain and Central Nervous System Tumors and Seizure, run by Dr Andrea Rossetti at 2 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Seizure
- What is being tested?
- levetiracetam and pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2008to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
USZ
Zurich, CH-8091
About this study
Official title: Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.
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.
Read the 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
- Being tested
- levetiracetam, pregabalin
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Seizures, Astrocytoma, Glioblastoma, Gliosarcoma, Neuroectodermal Tumors, Primitive, Medulloblastoma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
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.
pregabalinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Active comparator | Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year Receives: Drug: pregabalin |
| Pregabalin | Active comparator | Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to visit at 12 months
Secondary outcomes (6)
Adverse events
Measured: baseline to visit at 12 months
Anxiety
Measured: baseline to visit at 12 months
Need to add a second AED
Measured: baseline to visit at 12 months
Study drug discontinuation
Measured: baseline to visit at 12 months
Occurrence of consciousness-impairing seizures or status epilepticus
Measured: baseline to visit at 12 months
Mortality
Measured: baseline to visit at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Andrea Rossetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Andrea Rossetti, Centre Hospitalier Universitaire Vaudois
- Investigators
- Andrea O. Rossetti, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629889
- Sponsor's protocol ID
- CDR0000586523
- Other IDs
- CHUV-Neurology-CePO-LEV-PGB, EU-20807
- Status last verified
- May 2013
- First submitted
- 5 Mar 2008
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.
- ClinicalTrials.gov ID
- NCT00629889
- Acronym / sponsor ID
- CDR0000586523
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dr Andrea RossettiUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Active comparator | Drug: pregabalinPatients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year |
| Pregabalin | Active comparator | Drug: levetiracetamPatients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levetiracetamAfter 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. | Drug | Pregabalin |
| pregabalinAfter 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. | Drug | Levetiracetam |
Primary outcome
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
6 secondary outcomes
Adverse events
Time frame: baseline to visit at 12 months
Anxiety
Time frame: baseline to visit at 12 months
Need to add a second AED
Time frame: baseline to visit at 12 months
Study drug discontinuation
Time frame: baseline to visit at 12 months
Occurrence of consciousness-impairing seizures or status epilepticus
Time frame: baseline to visit at 12 months
Mortality
Time frame: baseline to visit at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea O. Rossetti, MD principal investigator
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levetiracetam and pregabalin in people with Brain and Central Nervous System Tumors and Seizure, run by Dr Andrea Rossetti at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.