Epilepsy
Conditions
Keywords
NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, N01175 (NCT00175903)
Brief 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 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.
Interventions
DRUGLevetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Subjects withdrawn from N01175 (NCT00175903) trial for any reason * Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial * Subject requiring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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months | Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months |
Countries
Belgium, Bulgaria, Finland, France, Poland, Switzerland
Participant flow
Recruitment details
Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.
Participants by arm
| Arm | Count |
|---|---|
| Levetiracetam Open- Label Treatment Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | Levetiracetam Open- Label Treatment |
|---|---|
| Age, Continuous | 40.68 years STANDARD_DEVIATION 18.35 |
| Region of Enrollment Belgium | 25 participants |
| Region of Enrollment Bulgaria | 31 participants |
| Region of Enrollment Finland | 9 participants |
| Region of Enrollment France | 18 participants |
| Region of Enrollment Poland | 32 participants |
| Region of Enrollment Switzerland | 15 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 130 |
| serious Total, serious adverse events | 6 / 130 |
Outcome results
Primary
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).
Time frame: during open-label therapy phase of 18 months
Population: Safety population that includes all subjects that have been treated once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with at least one AE | 40 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with AEs leading to dose change | 8 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with AEs leading to trial discontinuation | 1 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with drug-related AEs | 16 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with AEs of severe intensity | 4 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with serious AEs | 6 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Subjects with study drug-related serious AEs | 0 participants |
| Levetiracetam Open- Label Treatment | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Number of deaths | 0 participants |
Secondary
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
Population: Subjects with a discontinuation visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levetiracetam Open- Label Treatment | Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months | 0.71 kg | Standard Deviation 3.16 |