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Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

January 2, 2020

Overview

In this trial investigators are studying the effects of the drug Vinpocetine in people with epilepsy, particularly to see if it improves cognitive function and reduces seizure frequency or duration. Investigators will also monitor the safety of the drug in patients with epilepsy and healthy control subjects. Vinpocetine has been shown to improve cerebral metabolism and have anticonvulsant effects, which is why investigators are hopeful that it will aid in epilepsy management.

 

Study Information

In this trial, 30 participants will enroll and receive either the drug Vinpocetine or a placebo. All participants will be monitored for adverse events and CNS vitals composite score.

 

Inclusion Criteria

 

  • Adults (18-60 years old) with localization related epilepsy
  • Patient is on stable antiepileptic drug therapy for the last 2 months and is willing to remain on the same therapy for the duration of the study.
  • Proficient English
  • Patient complains of memory problems.
  • Neurological Disorders Depression Index -Epilepsy (NDDI-E) score <16
  • Mini-Mental Status Exam (MMSE) score <22
  • No history of status epilepticus in last year
  • No prior epilepsy surgeries
  • Stable antiepileptic drug (AED) therapy for last 2 months or more and willing not to change for 2 months. Vinpocetine will be stopped and the patient will be withdrawn from the study if marked changes occur in seizures or if other adverse events occur.
  • Use of appropriate contraception in woman of childbearing potential. This must include complete abstinence for the duration of the study or use of a barrier method plus one other contraceptive method (e.g. hormonal contraception or IUD).

 

Exclusion Criteria

 

  • Major medical disease (e.g., diabetes, heart disease, active cancer, depression)
  • Use of centrally active medications
  • History of allergy to vinpocetine
  • Progressive Cerebral Disease (e.g., Alzheimer’s disease)
  • Aphasia
  • Taking more than 3 AEDs
  • Pregnancy or lactation
  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (‘Yes’) to either Question 4 or Question 5 of the C-SSRS at Screening.

 

Location

Stanford University

Palo Alto, California, United States, 94304

Contact: Jordan Seliger    650-468-8740 jseliger@stanford.edu  

Principal Investigator: Kimford J Meador, MD     

 

Sponsors/Collaborators

Stanford University

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