Phase 3
N=509
Pregabalin Versus Levetiracetam In Partial Seizures
Partial Seizures
Bottom Line
View on ClinicalTrials.gov: NCT00537238 ↗Enrolled (actual)
509
Serious AEs
9.4%
Results posted
Jul 2013
Primary outcome: Primary: Proportion of Participants With Response to Treatment — 0.59; 0.59 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); levetiracetam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Response to Treatment |
0.59; 0.59 | — |
| SECONDARY Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 |
-53.93; -57.28 | 0.3571 |
| SECONDARY Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 |
39.41; 38.94; 3.93; 6.33 | — |
| SECONDARY Percentage of Participants Without Seizures |
19.9; 27.6; 65.7; 66.2; 49.3; 59.0 | 0.0822 |
| SECONDARY Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up |
27.26; 26.09; 5.18; 5.01; -2.16; -1.70 | 0.1334 |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Score |
7.25; 7.34; 6.22; 6.00; 6.32; 6.06 | 0.8084 |
| SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) Score |
27.06; 28.10; 30.72; 32.42; 15.72; 17.26 | 0.6161 |
| SECONDARY Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score |
56.0; 55.6; 58.3; 50.2 | 0.9285 |
Summary
This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.
Eligibility Criteria
Inclusion Criteria
- Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
- Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
- Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
Exclusion Criteria
- Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
- Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
Data sourced from ClinicalTrials.gov (NCT00537238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.