EpilepsyPhase 3NCT00291655
Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
A Phase 3 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma at 35 sites in 6 countries.
Trial summary
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 35 sitesin 6 countries
- Study dates
- Jun 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male/female adult subjects (≥ 16 or 18 years)
- Diagnosis of epilepsy (all types of seizures may be included)
- Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy
- Other inclusion criteria may apply
Who cannot join
- Subjects withdrawn from N01175 (NCT00175903) trial for any reason
- Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
- Subject requiring add-on antiepileptic treatment
- Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
- Sexually active woman with childbearing potential who is not using a medically accepted birth control method
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
France13 sites
Study site
Blaye
Study site
Bordeaux
Study site
Brest
Study site
Carcassonne
Study site
Cherbourg
Study site
Lille
Study site
Lyon
Study site
Nancy
Study site
Rennes
Study site
Saint-Brieuc
Study site
Saint-Quentin
Study site
Toulouse
Study site
Valenciennes
Belgium8 sites
Study site
Bruges
Study site
Edegem
Study site
Ghent
Study site
Haine-Saint-Paul
Study site
Jette
Study site
Kortrijk
Study site
Leuven
Study site
Ostend
Poland5 sites
Study site
Częstochowa
Study site
Krakow
Study site
Olsztyn
Study site
Poznan
Study site
Warsaw
Switzerland4 sites
Study site
Biel
Study site
Lausanne
Study site
Sankt Gallen
Study site
Zurich
About this study
Official title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
- Conditions
- Epilepsy
- Being tested
- Levetiracetam
- Keywords
- NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, N01175 (NCT00175903)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam (LEV) | Experimental | Not described Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
Measured: during open-label therapy phase of 18 months
Secondary outcomes (1)
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Measured: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291655
- Sponsor's protocol ID
- N01237
- Other IDs
- EUDRACT NUMBER: 2006-000173-29
- Status last verified
- Apr 2015
- First submitted
- 10 Feb 2006
- Last updated
- 18 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).
- ClinicalTrials.gov ID
- NCT00291655
- Acronym / sponsor ID
- N01237
- Conditions
- Epilepsy
- Keywords
- NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, N01175 (NCT00175903)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Posted 13 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam (LEV) | Experimental | Drug: Levetiracetam |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male/female adult subjects (≥ 16 or 18 years)
- Diagnosis of epilepsy (all types of seizures may be included)
- Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy
- Other inclusion criteria may apply
Key exclusion criteria (5 listed)
- Subjects withdrawn from N01175 (NCT00175903) trial for any reason
- Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
- Subject requiring add-on antiepileptic treatment
- Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
- Sexually active woman with childbearing potential who is not using a medically accepted birth control method
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 |
|---|---|---|
| Levetiracetam500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study | Drug | Levetiracetam (LEV) |
Primary outcome
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Time frame: during open-label therapy phase of 18 months
Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
1 secondary outcome
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Time frame: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma at 35 sites in 6 countries.
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 4 inclusion and 5 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France, Belgium, Poland, Switzerland, Finland and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase (time frame: during open-label therapy phase of 18 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 18 May 2015.