Primary Brain TumorPhase 4NCT00571155
Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery
A Phase 4 study testing levetiracetam in people with Primary Brain Tumor and Epilepsy, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Brain Tumor, Epilepsy
- What is being tested?
- levetiracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Aug 2009
- Phase
- Phase 4
- 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
Who may be able to join
- age ≥ 18 years
- suspected primary brain tumor by imaging
- planned bioptical or cytoreductive surgery of the tumor
- symptomatic epilepsy
- Karnofsky performance score ≥ 70%
- women with child bearing potential must perform sufficient contraception
- sufficient haematologic, hepatic and renal function by laboratory testing
Who cannot join
- treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery
- known allergic reaction to levetiracetam or other serious side effects
- known, not tumor-induced, epilepsy
- previous brain surgery
- dementia
- participation in another clinical trial
- addiction to drugs or alcohol
- pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of General Neurology
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)
The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
- Conditions
- Primary Brain Tumor, Epilepsy
- Being tested
- levetiracetam
- Medical subject headings
- Brain Neoplasms, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
Also called Keppra
oral and intravenous dosing 2000-3000 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
Measured: 1 year
Secondary outcomes (1)
Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Michael Weller, MD, Principal investigator, University-Hospital of Tuebingen, Department of General Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571155
- Sponsor's protocol ID
- HELLO-Study 2007
- Other IDs
- EudraCT Number: 2007-005063-96
- Status last verified
- Aug 2009
- First submitted
- 10 Dec 2007
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bahr O, Hermisson M, Rona S, Rieger J, Nussbaum S, Kortvelyessy P, Franz K, Tatagiba M, Seifert V, Weller M, Steinbach JP. Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial. Acta Neurochir (Wien). 2012 Feb;154(2):229-35; discussion 235. doi: 10.1007/s00701-011-1144-9. Epub 2011 Sep 10.
PubMed 21909835
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)
- ClinicalTrials.gov ID
- NCT00571155
- Acronym / sponsor ID
- HELLO-Study 2007
- Conditions
- Primary Brain Tumor, Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Dec 2007 (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.
The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: levetiracetam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 18 years
- suspected primary brain tumor by imaging
- planned bioptical or cytoreductive surgery of the tumor
- symptomatic epilepsy
- Karnofsky performance score ≥ 70%
Key exclusion criteria (8 listed)
- treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery
- known allergic reaction to levetiracetam or other serious side effects
- known, not tumor-induced, epilepsy
- previous brain surgery
- dementia
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 |
|---|---|---|
| levetiracetamAlso: Keppraoral and intravenous dosing 2000-3000 mg per day | Drug | 1 |
Primary outcome
Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
Time frame: 1 year
1 secondary outcome
Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
Time frame: 1 year
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 20 Aug 2009.
- Derived from this study: PubMed 21909835Bahr O, Hermisson M, Rona S, Rieger J, Nussbaum S, Kortvelyessy P, Franz K, Tatagiba M, Seifert V, Weller M, Steinbach JP. Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial. Acta Neurochir (Wien). 2012 Feb;154(2):229-35; discussion 235. doi: 10.1007/s00701-011-1144-9. Epub 2011 Sep 10.
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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.
Michael Weller, MD principal investigator
University-Hospital of Tuebingen, Department of General Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levetiracetam in people with Primary Brain Tumor and Epilepsy, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. 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 20 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571155, which also lists 1 linked publication.
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 20 Aug 2009.