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Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

This study is currently recruiting participants.
Verified August 2017 by Kimford Jay Meador, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011971
First Posted: December 16, 2013
Last Update Posted: August 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kimford Jay Meador, Stanford University
  Purpose
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.

Condition Intervention Phase
Epilepsy Drug: Vinpocetine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Double-blind single dose crossover with 1-month follow-up open label in patients.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

Resource links provided by NLM:


Further study details as provided by Kimford Jay Meador, Stanford University:

Primary Outcome Measures:
  • Change in CNS Vitals Composite Score [ Time Frame: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12 ]
    CNS Vitals consists of multiple subtasks that provide an overall composite score will be the primary outcome measure


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12 ]
    safety outcome


Estimated Enrollment: 30
Actual Study Start Date: February 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose
Vinpocetine 10 mg Healthy subjects
Drug: Vinpocetine
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
Other Names:
  • 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
Active Comparator: Mid-dose 1
Vinpocetine 20mg Healthy subjects
Drug: Vinpocetine
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
Other Names:
  • 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
Placebo Comparator: Placebo
0 dose of vinpocetine Healthy and Epilepsy subjects
Drug: Vinpocetine
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
Other Names:
  • 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
Active Comparator: High Dose
Vinpocetine 60 mg single dose Healthy Subjects & 20mg tid Epilepsy Subjects
Drug: Vinpocetine
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
Other Names:
  • 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

Detailed Description:

Cognitive problems are common in patients with epilepsy, but there is currently no specific treatment available. 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 drugs (i.e., carbamazepine, phenytoin, valproate, oxcarbazepine, lamotrigine and topiramate) in inhibiting both sodium and calcium channels, which control release of excitatory neurotransmitters that can lead to brain injury. Thus, vinpocetine might offer a unique drug to help cognition in patients with epilepsy. The investigators propose to conduct 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.

Specific Aim 1a: To determine if vinpocetine enhances memory and other cognitive functions in healthy volunteers.

Specific Aim 1b: To determine blood levels from 3 different acute oral doses of vinpocetine in healthy volunteers.

Specific Aim 2a: To provide safety and preliminary of efficacy data that vinpocetine can enhance memory and other cognitive functions in patients with epilepsy.

Specific Aim 2b: To determine blood levels from acute and chronic oral doses of vinpocetine in patients with epilepsy as well as effects on anticonvulsant blood levels.

Specific Aim 2c: To provide preliminary of data that vinpocetine can reduce seizure frequency or duration in patients with epilepsy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria - Healthy (enrollment of healthy volunteers has been completed)

  1. Healthy adults 18-60 years old
  2. Proficient English
  3. 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).

Inclusion Criteria -Epilepsy

  1. Adults (18-60 years old) with localization related epilepsy
  2. 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.
  3. Proficient English
  4. Patient complains of memory problems.
  5. Neurological Disorders Depression Index -Epilepsy (NDDI-E) score <16
  6. Mini-Mental Status Exam (MMSE) score <22
  7. No history of status epilepticus in last year
  8. No prior epilepsy surgeries
  9. 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.
  10. 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).

Exclusion Criteria -Healthy:

  1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression)
  2. 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.
  3. Use of centrally active medications
  4. History of allergy to vinpocetine
  5. Scores onintelligence quotient (IQ) <80 or Medical College of Georgia (MCG) Paragraph score < 2 standard deviations below norm.
  6. Pregnancy or lactation.

Exclusion Criteria- Epilepsy

  1. Major medical disease (e.g., diabetes, heart disease, active cancer, depression)
  2. Use of centrally active medications
  3. History of allergy to vinpocetine
  4. Progressive Cerebral Disease (e.g., Alzheimer's disease)
  5. Aphasia
  6. Taking more than 3 AEDs
  7. Pregnancy or lactation
  8. 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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02011971


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

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Jordan Seliger    650-468-8740    jseliger@stanford.edu   
Principal Investigator: Kimford J Meador, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kimford J Meador, MD Stanford University
  More Information

Responsible Party: Kimford Jay Meador, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02011971     History of Changes
Other Study ID Numbers: IRB00044949
Stanford Vinpocetine ( Other Identifier: Other )
First Submitted: December 4, 2013
First Posted: December 16, 2013
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by Kimford Jay Meador, Stanford University:
epilepsy
cognition
memory

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vinpocetine
Vinca Alkaloids
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators