Epilepsy
Conditions
Keywords
open-label, extension study, pregabalin, partial epilepsy
Brief summary
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
Interventions
DRUGpregabalin
pregabalin
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed the previous protocol and wish to continue to receive pregabalin. * Diagnosis of epilepsy with partial seizures
Exclusion criteria
* Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Frequency | Baseline up to Week 28 | — |
| Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 28 | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Baseline up to Week 28 | Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. |
Countries
Czechia, Hong Kong, Ukraine, United States
Participant flow
Pre-assignment details
Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Enrolled, not treated | 2 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Unpecified | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Customized 18-44 years | 48 Participants |
| Age, Customized 45-64 years | 23 Participants |
| Age, Customized Greater than or equal to (≥) 65 years | 4 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 73 |
| serious Total, serious adverse events | 3 / 73 |
Outcome results
Primary
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline up to Week 28
Population: Safety analysis set population: all participants who received at least 1 dose of pregabalin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 30 Participants |
| Pregabalin | Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious AEs (SAEs) | 3 Participants |
Primary
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
Time frame: Baseline up to Week 28
Population: Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 17 Participants |
Primary
Seizure Frequency
Time frame: Baseline up to Week 28
Population: Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.