Phase 3
N=323
Once-A-Day Pregabalin For Partial Seizures
Partial Seizures · Epilepsies, Partial
Bottom Line
View on ClinicalTrials.gov: NCT01262677 ↗Enrolled (actual)
323
Serious AEs
3.7%
Results posted
Jun 2018
Primary outcome: Primary: Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase — 2.24; 2.33; 2.32; 1.84 ln (seizures per 28 days) — p=0.9076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase |
2.24; 2.33; 2.32; 1.84; 1.80; 1.93 | 0.9076 |
| SECONDARY Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase |
37.8; 45.9; 35.8; 62.2; 54.1; 64.2 | 0.752 |
| SECONDARY Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase |
-15.00; -31.54; -5.70 | 0.5404 |
| SECONDARY Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase |
3.99; 4.43; 7.51 | 0.6073 |
| SECONDARY Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase |
0.46; 0.48; 0.48 | 0.8268 |
| SECONDARY Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase |
1.0; 1.9; 1.9 | 0.670 |
| SECONDARY Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase |
1.91; 1.77; 1.88 | 0.8034 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 |
-0.8; -0.4; -0.5 | 0.4650 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 |
-0.5; -0.8; -0.1 | 0.2693 |
| SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 |
-3.9; -1.5; -1.9 | 0.7347 |
| SECONDARY Change From Baseline in MOS-SS - Snoring Score at Week 14 |
-3.5; 5.4; -0.6 | 0.3972 |
| SECONDARY Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14 |
0.2; 1.0; -0.8 | 0.7708 |
| SECONDARY Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14 |
0.2; -0.1; -0.1 | 0.1129 |
| SECONDARY Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14 |
2.3; -1.7; -1.5 | 0.9053 |
| SECONDARY Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14 |
-0.5; 5.2; 5.0 | 0.0119 sig |
| SECONDARY Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14 |
-2.2; 0.4; 0.3 | 0.5903 |
| SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14 |
-2.4; 0.7; 0.7 | 0.2431 |
| SECONDARY Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale |
67.7; 60.2; 60.2 | 0.3241 |
| SECONDARY Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question |
12.0; 17.9; 22.0; 31.0; 23.2; 33.0 | — |
| SECONDARY BSW: Satisfaction From Treatment Question |
13.0; 17.9; 23.9; 84.0; 80.4; 73.4 | — |
| SECONDARY BSW: Willingness to Continue Question |
18.0; 22.3; 26.6; 79.0; 75.9; 70.6 | — |
| SECONDARY Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase |
1.0; 2.7; 0.0; 2.0; 6.2; 4.5 | — |
| SECONDARY Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase |
79.0; 78.8; 68.2; 21.0; 21.2; 31.8 | — |
| SECONDARY Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) |
2.0; 1.8; 5.5; 1.0; 1.8; 4.5 | — |
| SECONDARY Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase |
1.0; 1.8; 0.9; 5.1; 5.5; 2.8 | — |
| SECONDARY Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms |
8.0; 5.3; 10.0; 1.0; 0.0; 0.9 | — |
| SECONDARY Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase |
1.1; 1.0; 2.1; 1.1; 1.9; 1.0 | — |
| SECONDARY Percentage of Participants With Laboratory Test Abnormalities During the Study |
1.0; 0.9; 0.9; 0.0; 0.9; 0.0 | — |
Summary
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
- Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs
Exclusion Criteria
- Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
- Status epilepticus within one year prior to screening
Data sourced from ClinicalTrials.gov (NCT01262677). 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.