Phase 4
N=187
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Epilepsies, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00351611 ↗Enrolled (actual)
187
Serious AEs
2.7%
Results posted
Feb 2021
Primary outcome: Primary: Percentage of Participants With a Decrease (p<0.05) From Baseline in Threshold Value in Any 5 or More Points in Humphrey 24-2 Swedish Interactive Threshold Algorithm (SITA) Standard Testing at Week 12 or Early Termination — 3.8; 5.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lyrica (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
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Decrease (p<0.05) From Baseline in Threshold Value in Any 5 or More Points in Humphrey 24-2 Swedish Interactive Threshold Algorithm (SITA) Standard Testing at Week 12 or Early Termination |
3.8; 5.6 | — |
| SECONDARY Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination |
-0.339; -0.214 | 0.4414 |
| SECONDARY Change From Baseline in Visual Acuity at Week 12 or Early Termination |
-1.890; -0.990 | 0.1346 |
Summary
Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.
Eligibility Criteria
Inclusion Criteria
- Epilepsy partial seizure subjects.
- Currently taking 1 to 3 antiepileptic drugs.
Exclusion Criteria
- Pre-existing eye diseases (glaucoma).
- Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.
Data sourced from ClinicalTrials.gov (NCT00351611). 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.