NCT01128712

Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin

An Open Label, Randomized Study Prospectively Examining the Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Northeast Regional Epilepsy Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB) therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant antiepileptic drugs (AEDs).

Detailed description

Background Interictal anxiety symptoms are reported in two-thirds of patients with epilepsy and represent an underrecognized and undertreated aspect of the disorder. Interictal anxiety is postulated to stem from both fear of seizure recurrence ("seizure phobia") and dispersed locus of control.In addition, anxiety and the most common forms of partial onset epilepsy are viewed to arise from dysfunction in a common neurobiological substrate-the amygdala and other structures within the limbic system. Background on Pregabalin Pregabalin (CI-1008,Lyrica) is a chemical analogue of the mammalian neurotransmitter gamma-aminobutyric acid (GABA),although it does not bind to or activates GABA receptors or inhibit GABA uptake. Pregabalin is an alpha-2-delta ligand that has analgesic, anxiolytic, and antiepileptic activity. Rationale Antiepileptic drugs (AEDs) are commonly used for mood disorders including anxiety.Pregabalin (PGB) the most recently FDA-approved AED for add-on therapy for refractory partial seizures also has demonstrated efficacy in Generalized Anxiety Disorder. PGB binds to the alpha-2-delta subunit protein of voltage-gated calcium channels, and in animal models, has anxiolytic and anti-epileptic effects via pre-synaptic inhibition of the release of several excitatory neurotransmitters.

Conditions

• Epilepsy, Complex Partial

Interventions

Type	Name	Description
DRUG	Pregabalin	150 mg /day
DRUG	Pregabalin	450 mg/day

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-05-24
• Last updated: 2017-09-14

Locations

1 site across 1 country: United States