Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

NCT02011971 | Suspended Phase 1

• 2 other identifiers: IRB00044949Stanford Vinpocetine
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot studies in healthy volunteers and in patients with epilepsy to assess the potential efficacy and safety of different dosages of vinpocetine in improving cognition.

Conditions

Epilepsy

Keywords

epilepsy; cognition; memory

Outcome Measures

Primary Outcomes (1)

• Change in CNS Vitals Composite Score

  CNS Vitals consists of multiple subtasks that provide an overall composite score will be the primary outcome measure

  Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12

Secondary Outcomes (1)

• Adverse Events

  Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12

Study Arms (4)

Low dose

ACTIVE COMPARATOR

Vinpocetine 10 mg Healthy subjects

Drug: Vinpocetine

Mid-dose 1

ACTIVE COMPARATOR

Vinpocetine 20mg Healthy subjects

Drug: Vinpocetine

Placebo

PLACEBO COMPARATOR

0 dose of vinpocetine Healthy and Epilepsy subjects

Drug: Vinpocetine

High Dose

ACTIVE COMPARATOR

Vinpocetine 60 mg single dose Healthy Subjects \& 20mg tid Epilepsy Subjects

Drug: Vinpocetine

Interventions

Vinpocetine DRUG

Vinpocetine is a chemical obtained from the leaves of the Lesser Periwinkle. It has been shown to improve cerebral metabolism and memory in animals and humans. In addition, it has been shown to enhance long-term potentiation, which has been linked to memory mechanisms. Furthermore, vinpocetine has been shown to have anticonvulsant effects and is more potent than several commonly used antiepileptic drug

Also known as: ethyl apovincaminate, ethyl apovincaminoate, eburnamenine-14-carboxylic acid ethyl ester, 3 alpha, 16 alpha-apovincaminic acid ethyl ester, ethyl apovincamin-22-oate, Cavinton®, Ceractin, ARGH-4405

High Dose; Low dose; Mid-dose 1; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults 18-60 years old
• Proficient English
• Use of appropriate contraception if 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 intrauterine device, IUD).
• Adults (18-60 years old) with localization related epilepsy
• Patient is on stable antiepileptic drug therapy for last 2 months and is willing to remain on 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 if 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).

You may not qualify if:

• Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression)
• 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 Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
• Use of centrally active medications
• History of allergy to vinpocetine
• Scores onintelligence quotient (IQ) \<80 or Medical College of Georgia (MCG) Paragraph score \< 2 standard deviations below norm.
• Pregnancy or lactation.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

vinpocetine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kimford J Meador, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind single dose crossover with 1-month follow-up open label in patients.

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 16, 2013
• Study Start: February 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

US (1)