Clinical Trial: Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Northeast Regional Epilepsy Group

Current Primary Outcome: Change in Beck Anxiety Score [ Time Frame: week 0 - week 6 ]

The primary outcome variable will be the change in the Beck Anxiety Inventory (BAI) score as measured at the baseline and final visits.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in BDI , NHS3 , STAI , NDDI-E and seizure frequency [ Time Frame: week 0 - week 6 ]

The secondary outcome variables will be the change in the Beck Depression Inventory, change in National Hospital Seizure Severity Scale (NHS3) score, change in seizure frequency, change in Stait-Trait Anxiety Scale (STAI),and change in the National Disorders Depression Inventory for Epilepsy Screening Tool (NDDI-E) as measured at the baseline and final visits.


Original Secondary Outcome: Same as current

Information By: Northeast Regional Epilepsy Group

Dates:
Date Received: May 20, 2010
Date Started: April 2010
Date Completion:
Last Updated: September 23, 2014
Last Verified: September 2014