EpilepsyPhase 3NCT01954121
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
A Phase 3 study testing Levetiracetam and Carbamazepine in people with Epilepsy and Partial Seizures, run by UCB Pharma SA at 28 sites in China.
Trial summary
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Partial Seizures
- What is being tested?
- Levetiracetam and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 28 sitesChina
- Study dates
- Sep 2013to Sep 2015
- 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
- Subject is of Chinese origin and ≥ 16 years of age
- Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
- Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
- Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS
Who cannot join
- Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele
- Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
- Subject has only experienced type IA nonmotor seizures
- Subject has a history or presence of seizures occurring only in clustered patterns
- Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
- Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
- Subject has a history of Status Epilepticus
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
13
Beijing
16
Changchun
10
Chengdu
5
Chengdu
4
Chongqing
11
Guangzhou
1
Guangzhou
20
Guangzhou
26
Guangzhou
24
Hangzhou
22
Harbin
29
Kunming
21
Nanjing
23
Nanjing
6
Nanjing
8
Nanjing
27
Qingdao
14
Shanghai
15
Shanghai
18
Shanghai
2
Shanghai
19
Shijiazhuang
3
Suzhou
9
Taiyuan
25
Tianjin
12
Wuhan
17
Xi'an
7
Xi'an
About this study
Official title: An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).
- Conditions
- Epilepsy, Partial Seizures
- Being tested
- Levetiracetam, Carbamazepine
- Keywords
- Levetiracetam, Keppra, Monotherapy, China, Epilepsy, Partial-onset Seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Immediate release film-coated tablets at strengths of 250 mg and 500 mg.
- Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid)
- Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid
- Down-titration Period (Week 30 up to Week 33)
CarbamazepineDrug
Also called Tegretol
Immediate release tablets at a strength of 200 mg.
- Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd)
- Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid
- Down-titration Period (Week 30 up to Week 33)
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Levetiracetam 1000 mg/day Receives: Drug: Levetiracetam |
| Carbamazepine | Active comparator | Carbamazepine 400 mg/day Receives: Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
Measured: 6-months Evaluation Period (From Week 4 to Week 30)
Secondary outcomes (4)
Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
Measured: From Week 1 to Week 30
Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Measured: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Evaluation Period
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Measured: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Measured: From Randomization (Week 1) up to Evaluation Visit (Week 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 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 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954121
- Sponsor's protocol ID
- N01364
- Status last verified
- Jul 2017
- First submitted
- 26 Sep 2013
- Last updated
- 15 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures
- ClinicalTrials.gov ID
- NCT01954121
- Acronym / sponsor ID
- N01364
- Conditions
- Epilepsy, Partial Seizures
- Keywords
- Levetiracetam, Keppra, Monotherapy, China, Epilepsy, Partial-onset Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Posted 11 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: LevetiracetamLevetiracetam 1000 mg/day |
| Carbamazepine | Active comparator | Drug: CarbamazepineCarbamazepine 400 mg/day |
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)
- Subject is of Chinese origin and ≥ 16 years of age
- Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
- Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
- Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS
Key exclusion criteria (7 listed)
- Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele
- Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
- Subject has only experienced type IA nonmotor seizures
- Subject has a history or presence of seizures occurring only in clustered patterns
- Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
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: KeppraImmediate release film-coated tablets at strengths of 250 mg and 500 mg. * Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid) * Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid * Down-titration Period (Week 30 up to Week 33) | Drug | Levetiracetam |
| CarbamazepineAlso: TegretolImmediate release tablets at a strength of 200 mg. * Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd) * Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid * Down-titration Period (Week 30 up to Week 33) | Drug | Carbamazepine |
Primary outcome
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
Time frame: 6-months Evaluation Period (From Week 4 to Week 30)
4 secondary outcomes
Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
Time frame: From Week 1 to Week 30
Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period
Time frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Evaluation Period
Time frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug
Time frame: From Randomization (Week 1) up to Evaluation Visit (Week 30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Product InformationLink provided by the sponsor.
- 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)
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam and Carbamazepine in people with Epilepsy and Partial Seizures, run by UCB Pharma SA at 28 sites in China.
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 7 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. 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 11 Aug 2016). 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?
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period (time frame: 6-months Evaluation Period (From Week 4 to Week 30)). 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 15 Aug 2017.