Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

Viatris

Status and phase: Completed; Phase 4

Conditions: Epilepsies, Partial

Treatments: Drug: placebo; Drug: Lyrica (pregabalin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351611

A0081096

2009-014269-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

187 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Active drug

Treatment:

Drug: Lyrica (pregabalin)

Placebo

Placebo Comparator group

Description:

placebo comparator

Treatment:

Drug: placebo