Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

This study has suspended participant recruitment.
(Currently on hold pending interim analysis and donor funding of 2nd half of the project as originally agreed.)
Sponsor:
Information provided by (Responsible Party):
kmeador@stanford.edu, Emory University
ClinicalTrials.gov Identifier:
NCT02011971
First received: December 4, 2013
Last updated: June 2, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Emory University:

Primary Outcome Measures:
  • Change in CNS Vitals Composite Score [ Time Frame: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    safety outcome


Enrollment: 14
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria - Healthy

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011971

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kimford J Meador, MD Emory University
  More Information

No publications provided

Responsible Party: kmeador@stanford.edu, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02011971     History of Changes
Other Study ID Numbers: IRB00044949, Emory Vinpocetine
Study First Received: December 4, 2013
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
epilepsy
cognition
memory

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

ClinicalTrials.gov processed this record on November 19, 2014