Epilepsy, Complex Partial Clinical Trial
Official title:
An Open Label, Randomized Study Prospectively Examining the Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
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).
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00143143 -
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT01002820 -
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
|
Phase 2 | |
| Completed |
NCT00001489 -
Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
|
N/A | |
| Completed |
NCT00425282 -
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00433667 -
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT03156439 -
Bioavailability, Safety, and Tolerability of BIS-001 ER
|
Phase 1 | |
| Completed |
NCT04573569 -
Neural Correlates of Cognition and Mood
|
||
| Completed |
NCT00744731 -
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
|
Phase 3 | |
| Completed |
NCT00740623 -
A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00319501 -
Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.
|
Phase 3 | |
| Completed |
NCT00991757 -
An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00056576 -
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
|
Phase 3 |