Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01128712|
Recruitment Status : Terminated (lack of enrollment. terminated in 2014. no data analysis.)
First Posted : May 24, 2010
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Complex Partial||Drug: Pregabalin||Phase 4|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Randomized Study Prospectively Examining the Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
150 mg /day
Other Name: Lyrica
Other Name: Lyrica
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128712
|United States, New Jersey|
|Northeast Regional Epilepsy Group|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Evan Fertig, MD||Northeast Regional Epilepsy Group|