Generalized EpilepsyPhase 3NCT00150748
Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
A Phase 3 study testing Levetiracetam 166 mg, Levetiracetam 250 mg and Levetiracetam 500 mg in people with Generalized Epilepsy, run by UCB Pharma SA.
Trial summary
An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures. Read more about this study
- Who is it for?
- Ages 4 to 64 years
- Conditions the study is for
- Generalized Epilepsy
- What is being tested?
- Levetiracetam 166 mg, Levetiracetam 250 mg and Levetiracetam 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Jul 2007
- Phase
- Phase 3
- 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 4 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
- Subjects who were/are suffering from primary generalized (type II) epileptic seizures
- Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected
Who cannot join
- Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
- Concomitant use of any drug with possible central nervous system effects unless at a stable dose
- Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
About this study
Official title: An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures
An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.
- Conditions
- Generalized Epilepsy
- Being tested
- Levetiracetam 166 mg, Levetiracetam 250 mg, Levetiracetam 500 mg
- Keywords
- Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam
- Medical subject headings
- Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam 166 mgDrug
- Active Substance: Levetiracetam
- Pharmaceutical Form: Tablet
- Concentration: 166 mg
- Route of Administration: Oral use
Levetiracetam 250 mgDrug
- Active Substance: Levetiracetam
- Pharmaceutical Form: Tablet
- Concentration: 250 mg
- Route of Administration: Oral use
Levetiracetam 500 mgDrug
- Active Substance: Levetiracetam
- Pharmaceutical Form: Tablet
- Concentration: 500 mg
- Route of Administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.). Receives: Drug: Levetiracetam 166 mg; Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
Measured: Evaluation Period
Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
Measured: Evaluation Period
Secondary outcomes (8)
Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period
Measured: From Visit 1 to the end of the Evaluation Period
Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period
Measured: From Visit 1 to the end of the Evaluation Period
Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Measured: From N01057 or N166 Baseline to the Evaluation Period
Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Measured: From N01057 or N166 Baseline to the Evaluation Period
Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Measured: From N01057 or N166 Baseline to the Evaluation Period
Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Measured: From N01057 or N166 Baseline to the Evaluation Period
Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Measured: Evaluation Period
Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Measured: Evaluation Period
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 startNov 2001
- Primary completionJul 2007
- Study completionJul 2007
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 Generalized 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877-822-9493
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150748
- Sponsor's protocol ID
- N167
- Other IDs
- 2004-001997-13, 2004
- Status last verified
- Jul 2020
- First submitted
- 6 Sep 2005
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2.
PubMed 22050371
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures
- ClinicalTrials.gov ID
- NCT00150748
- Acronym / sponsor ID
- N167
- Conditions
- Generalized Epilepsy
- Keywords
- Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 8 Sep 2005 (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.
An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Levetiracetam 166 mg, Drug: Levetiracetam 250 mg, Drug: Levetiracetam 500 mgSubjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.). |
Who may qualify
- Ages
- 4 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
- Subjects who were/are suffering from primary generalized (type II) epileptic seizures
- Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected
Key exclusion criteria (3 listed)
- Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
- Concomitant use of any drug with possible central nervous system effects unless at a stable dose
- Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
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 |
|---|---|---|
| Levetiracetam 166 mg* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 166 mg * Route of Administration: Oral use | Drug | Levetiracetam |
| Levetiracetam 250 mg* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 250 mg * Route of Administration: Oral use | Drug | Levetiracetam |
| Levetiracetam 500 mg* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 500 mg * Route of Administration: Oral use | Drug | Levetiracetam |
Primary outcome
Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
Time frame: Evaluation Period
Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
Time frame: Evaluation Period
8 secondary outcomes
Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period
Time frame: From Visit 1 to the end of the Evaluation Period
Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period
Time frame: From Visit 1 to the end of the Evaluation Period
Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Time frame: From N01057 or N166 Baseline to the Evaluation Period
Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Time frame: From N01057 or N166 Baseline to the Evaluation Period
Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Time frame: From N01057 or N166 Baseline to the Evaluation Period
Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Time frame: From N01057 or N166 Baseline to the Evaluation Period
Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Time frame: Evaluation Period
Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Time frame: Evaluation Period
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 29 Jul 2020.
- Derived from this study: PubMed 22050371Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2.
Related trials for Generalized Epilepsy
RecruitingPhase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary Generalized Tonic-Clonic Seizures
RecruitingPhase 1/2
ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
Dravet Syndrome
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam 166 mg, Levetiracetam 250 mg and Levetiracetam 500 mg in people with Generalized Epilepsy, run by UCB Pharma SA.
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 3 inclusion and 3 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period (time frame: Evaluation Period). The study lists 2 primary outcomes in all. 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 NCT00150748, 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 29 Jul 2020.