Epilepsy, PartialPhase 3NCT00160615

Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

A Phase 3 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Japan Co. Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Epilepsy, Partial
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: 154 participants
Where: No sites listed yet
Study dates: 12 Sep 2001to 17 Jan 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

Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Who cannot join

Patients who had not participate in N165 Clinical Trial of L059.
Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

About this study

Conditions: Epilepsy, Partial
Being tested: Levetiracetam
Keywords: Epilepsy, partial, Keppra, Levetiracetam
Medical subject headings: Epilepsies, Partial

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: Film-coating tablets
- Concentration: 250 mg/ 500 mg
- Route of administration: oral use

Study groups in NCT00160615
Study group	Role	What they receive
Levetiracetam	Experimental	Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509). Receives: Drug: Levetiracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

Partial (Type I) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
Measured: From Baseline up to 54 months
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
Measured: From Baseline up to 54 months
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
Measured: From Baseline up to 54 months
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.
Measured: From Baseline up to 54 months

Secondary outcomes (4)

Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.
Negative values indicate improvement from Baseline.
Measured: From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.
Negative values indicate improvement from Baseline.
Measured: From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.
Negative values indicate improvement from Baseline.
Measured: From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.
Negative values indicate improvement from Baseline.
Measured: From Baseline up to 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 200117 Jan 2007

First posted12 Sep 2005 (estimated)
Study start12 Sep 2001
Primary completion17 Jan 2007
Study completion17 Jan 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, PartialStudies 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
Model description: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00160615
Sponsor's protocol ID: N01020
Status last verified: Mar 2019
First submitted: 8 Sep 2005
Last updated: 10 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

All Epilepsy, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
ClinicalTrials.gov ID: NCT00160615
Acronym / sponsor ID: N01020
Conditions: Epilepsy, Partial
Keywords: Epilepsy, partial, Keppra, Levetiracetam
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: UCB Japan Co. Ltd.Industry (pharma, biotech, devices)
Study start: 12 Sep 2001 (actual)
Primary completion: 17 Jan 2007 (actual)
Study completion: 17 Jan 2007 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 10 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Arm	Type	Receives
Levetiracetam	Experimental	Drug: LevetiracetamSubjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Key exclusion criteria (3 listed)

Patients who had not participate in N165 Clinical Trial of L059.
Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

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: Keppra* Pharmaceutical form: Film-coating tablets * Concentration: 250 mg/ 500 mg * Route of administration: oral use	Drug	Levetiracetam

Primary outcome

Partial (Type I) Seizure Frequency Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

4 secondary outcomes

Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
Time frame: From Baseline up to 54 months
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
Time frame: From Baseline up to 54 months

Results and safety

Results posted to the registry on 10 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N165 Randomized Treatment PBO	50	32
N165 Randomized Treatment LEV	101	56

Primary outcome: Partial (Type I) Seizure Frequency Per Week by Analysis Visit

Time frame: From Baseline up to 54 months. Median (Inter-Quartile Range). Unit: Number of Seizures (Type I) per week

Measure	N165 Randomized Treatment PBO n = 50	N165 Randomized Treatment LEV n = 101
>= 1 day(d) - <= 3 months(m)	1.68 (1.18 to 4.06)	2.19 (0.99 to 5.41)
> 3 m - <= 6 m	1.69 (1.00 to 2.75)	2.00 (0.87 to 4.48)
> 6 m - <= 9 m	1.58 (0.88 to 2.69)	1.78 (0.68 to 4.94)
> 9 m - <= 12 m	1.41 (0.95 to 3.25)	1.60 (0.60 to 5.05)
> 12 m - <= 15 m	1.58 (1.06 to 2.50)	1.55 (0.80 to 4.67)
> 15 m - <= 18 m	1.36 (1.03 to 2.32)	1.69 (0.75 to 4.80)
> 18 m - <= 21 m	1.35 (0.72 to 1.96)	1.51 (0.62 to 4.49)
> 21 m - <= 24 m	1.30 (0.75 to 1.98)	1.36 (0.67 to 3.17)

Population analysed: Full Analysis set included 151 subjects. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Primary outcome: Partial (Type IA) Seizure Frequency Per Week by Analysis Visit

Time frame: From Baseline up to 54 months. Median (Inter-Quartile Range). Unit: Number of Seizures (Type IA) per week

Measure	N165 Randomized Treatment PBO n = 23	N165 Randomized Treatment LEV n = 61
>= 1 d - <= 3 m	0.86 (0.07 to 1.73)	0.68 (0.06 to 4.41)
> 3 m - <= 6 m	0.32 (0.06 to 1.44)	0.83 (0.06 to 3.31)
> 6 m - <= 9 m	0.24 (0.00 to 1.33)	0.63 (0.05 to 4.67)
> 9 m - <= 12 m	0.26 (0.00 to 1.23)	0.50 (0.00 to 3.47)
> 12 m - <= 15 m	0.57 (0.09 to 1.35)	0.22 (0.00 to 2.74)
> 15 m - <= 18 m	0.27 (0.00 to 1.32)	0.30 (0.00 to 2.81)
> 18 m - <= 21 m	0.10 (0.00 to 1.38)	0.42 (0.00 to 1.82)
> 21 m - <= 24 m	0.17 (0.06 to 1.00)	0.43 (0.05 to 1.60)

Population analysed: Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Primary outcome: Partial (Type IB) Seizure Frequency Per Week by Analysis Visit

Time frame: From Baseline up to 54 months. Median (Inter-Quartile Range). Unit: Number of Seizures (Type IB) per week

Measure	N165 Randomized Treatment PBO n = 44	N165 Randomized Treatment LEV n = 91
>= 1 d - <= 3 m	1.56 (0.94 to 2.49)	1.27 (0.50 to 3.25)
> 3 m - <= 6 m	1.51 (0.81 to 2.69)	1.13 (0.38 to 3.18)
> 6 m <= 9 m	1.30 (0.60 to 2.25)	0.92 (0.25 to 2.31)
> 9 m - <= 12 m	1.39 (0.80 to 1.88)	0.72 (0.24 to 2.11)
> 12 m - <= 15 m	1.34 (0.71 to 1.94)	0.81 (0.38 to 2.12)
> 15 m - <= 18 m	1.25 (0.81 to 2.21)	0.81 (0.35 to 1.88)
> 18 m - <= 21 m	1.25 (0.72 to 1.95)	0.58 (0.31 to 2.34)
> 21 m - <= 24 m	1.26 (0.70 to 1.90)	0.73 (0.26 to 2.65)

Population analysed: Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Primary outcome: Partial (Type IC) Seizure Frequency Per Week by Analysis Visit

Time frame: From Baseline up to 54 months. Median (Inter-Quartile Range). Unit: Number of Seizures (Type IC) per week

Measure	N165 Randomized Treatment PBO n = 18	N165 Randomized Treatment LEV n = 42
>= 1 d - <= 3 m	0.00 (0.00 to 0.31)	0.00 (0.00 to 0.19)
> 3 m - <= 6 m	0.00 (0.00 to 0.13)	0.00 (0.00 to 0.07)
> 6 m - <= 9 m	0.05 (0.00 to 0.19)	0.00 (0.00 to 0.13)
> 9 m - <= 12 m	0.06 (0.00 to 0.17)	0.00 (0.00 to 0.06)
> 12 m - <= 15 m	0.06 (0.00 to 0.07)	0.00 (0.00 to 0.03)
> 15 m - <= 18 m	0.00 (0.00 to 0.13)	0.00 (0.00 to 0.06)
> 18 m - <= 21 m	0.00 (0.00 to 0.17)	0.00 (0.00 to 0.00)
> 21 m - <= 24 m	0.05 (0.00 to 0.14)	0.00 (0.00 to 0.00)

Population analysed: Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N165 Randomized Treatment PBO (FAS)	12 of 50 (24%)	48 of 50 (96%)	0 of 50
N165 Randomized Treatment LEV (FAS)	22 of 101 (21.8%)	99 of 101 (98%)	1 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
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 Cares study director

001 844 599 2273 (UCB)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Japan Co. Ltd..

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 2 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 10 Jun 2019. 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?

Yes. Results are posted in the registry (first posted 10 Jun 2019). 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?

Partial (Type I) Seizure Frequency Per Week by Analysis Visit (time frame: From Baseline up to 54 months). The study lists 4 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 NCT00160615.

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 10 Jun 2019.