Epilepsy, Tonic-clonicPhase 3NCT00150813
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
A Phase 3 study testing Levetiracetam in people with Epilepsy, Tonic-clonic, run by UCB Pharma SA at 21 sites in 4 countries.
Trial summary
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Tonic-clonic
- 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
- 66 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 10 Aug 2005to 29 May 2007
- 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
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
- Male/female subjects (>= 16 years).
Who cannot join
- Need for an additional Antiepileptic Drug (AED).
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Poland7 sites
Study site
Bialystok
Study site
Gdansk
Study site
Katowice
Study site
Lodz
Study site
Lublin
Study site
Szczecin
Study site
Warsaw
Czechia5 sites
Study site
Beroun
Study site
Brno
Study site
České Budějovice
Study site
Prague
Study site
Rychnov nad Kněžnou
Sweden5 sites
Study site
Gothenburg
Study site
Helsingborg
Study site
Huddinge
Study site
Karlstad
Study site
Uppsala
Hungary4 sites
Study site
Budapest
Study site
Debrecen
Study site
Pécs
Study site
Szeged
About this study
Official title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
- Conditions
- Epilepsy, Tonic-clonic
- Being tested
- Levetiracetam
- Keywords
- Monotherapy, Epilepsy, Keppra, Levetiracetam
- Medical subject headings
- Epilepsy, Tonic-Clonic, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Pharmaceutical form: oral tablets Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Subjects received open-label Levetiracetam. Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Participants With Treatment Emergent Adverse Events
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Measured: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start10 Aug 2005
- Primary completion29 May 2007
- Study completion29 May 2007
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 Epilepsy, Tonic-clonicStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150813
- Sponsor's protocol ID
- N01127
- Status last verified
- Oct 2018
- First submitted
- 6 Sep 2005
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. 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 Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.
- ClinicalTrials.gov ID
- NCT00150813
- Acronym / sponsor ID
- N01127
- Conditions
- Epilepsy, Tonic-clonic
- Keywords
- Monotherapy, Epilepsy, Keppra, Levetiracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2005 (actual)
- Primary completion
- 29 May 2007 (actual)
- Study completion
- 29 May 2007 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 1 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: LevetiracetamSubjects received open-label 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)
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
- Male/female subjects (>= 16 years).
Key exclusion criteria (1 listed)
- Need for an additional Antiepileptic Drug (AED).
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: KeppraPharmaceutical form: oral tablets Route of administration: Oral use | Drug | Levetiracetam |
Primary outcome
Percentage Participants With Treatment Emergent Adverse Events
Time frame: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Cares study director
001 844 599 2273 (UCB)
21 sites in 4 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, Tonic-clonic, run by UCB Pharma SA at 21 sites in 4 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 1 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Poland, Czechia, Sweden, Hungary. 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 1 Oct 2018). 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?
Percentage Participants With Treatment Emergent Adverse Events (time frame: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks). 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 21 Nov 2018.