Phase 4
Completed N=187
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Epilepsies, Partial
Source: ClinicalTrials.gov NCT00351611 ↗
Enrolled (actual)
187
Serious AEs
2.7%
Results posted
Feb 2021
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.