A Phase 3 interventional study of Levetiracetam in Epilepsy, sponsored by UCB Pharma. Completed at 35 sites in 6 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-05-18.
Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 130 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Other inclusion criteria may apply
Exclusion Criteria:
Drug: Levetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
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
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
Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.
| Milestone | Levetiracetam Open- Label Treatment |
|---|---|
| Started | 130 |
| Completed | 115 |
| Not completed | 15 |
Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
| participants | Levetiracetam Open- Label Treatment |
|---|---|
| Subjects with at least one AE | 40 |
| Subjects with AEs leading to dose change | 8 |
| Subjects with AEs leading to trial discontinuation | 1 |
| Subjects with drug-related AEs | 16 |
| Subjects with AEs of severe intensity | 4 |
| Subjects with serious AEs | 6 |
| Subjects with study drug-related serious AEs | 0 |
| Number of deaths | 0 |
| kg | Levetiracetam Open- Label Treatment |
|---|---|
| Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months | 0.71 ± 3.16 |
Collected over Open-label treatment over 18 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levetiracetam Open- Label Treatment | — | 6/130 (4.6%) | 10/130 (7.7%) |
| Event | Levetiracetam Open- Label Treatment |
|---|---|
| Acute coronary syndromeCardiac disorders | 1/130 |
| Hepatic cirrhosisHepatobiliary disorders | 1/130 |
| Skin lacerationInjury, poisoning and procedural complications | 1/130 |
| Grand mal convulsionNervous system disorders | 1/130 |
| AlcoholismPsychiatric disorders | 1/130 |
| TonsillitisInfections and infestations | 1/130 |
| Foot fractureInjury, poisoning and procedural complications | 1/130 |
| Event | Levetiracetam Open- Label Treatment |
|---|---|
| Weight increasedInvestigations | 7/130 |
| Weight decreasedInvestigations | 3/130 |
| Age, Continuous(years) | Levetiracetam Open- Label Treatment |
|---|---|
| Mean | 40.68 ± 18.35 |
| Sex: Female, Male(Participants) | Levetiracetam Open- Label Treatment |
|---|---|
| Female | 58 |
| Male | 72 |
| Region of Enrollment(participants) | Levetiracetam Open- Label Treatment |
|---|---|
| France | 18 |
| Finland | 9 |
| Poland | 32 |
| Belgium | 25 |
| Bulgaria | 31 |
| Switzerland | 15 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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