Trial Outcomes & Findings for Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures (NCT NCT00596466)
NCT ID: NCT00596466
Last Updated: 2021-01-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
Baseline up to Week 28
Results posted on
2021-01-26
Participant Flow
Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
Enrolled, Treated
|
73
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Unpecified
|
2
|
|
Overall Study
Enrolled, not treated
|
2
|
Baseline Characteristics
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Baseline characteristics by cohort
| Measure |
Pregabalin
n=75 Participants
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.
|
|---|---|
|
Age, Customized
18-44 years
|
48 Participants
n=39 Participants
|
|
Age, Customized
45-64 years
|
23 Participants
n=39 Participants
|
|
Age, Customized
Greater than or equal to (≥) 65 years
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 28Population: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to Week 28Population: Safety analysis set population: all participants who received at least 1 dose of pregabalin.
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.
Outcome measures
| Measure |
Pregabalin
n=73 Participants
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.
|
|---|---|
|
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Non-serious AEs
|
30 Participants
|
|
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious AEs (SAEs)
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 28Population: Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.
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.
Outcome measures
| Measure |
Pregabalin
n=72 Participants
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.
|
|---|---|
|
Number of Participants With Laboratory Test Values of Potential Clinical Importance
|
17 Participants
|
Adverse Events
Pregabalin
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=73 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
1/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
2.7%
2/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
1/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Pregabalin
n=73 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
5.5%
4/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
4.1%
3/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
3/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
4.1%
3/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.5%
4/73
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER