Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy - Full Text View

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 Masking: Double Blind (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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Further study details as provided by kmeador@stanford.edu, 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 ]
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


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	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


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

Criteria

Inclusion Criteria - Healthy

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).

Inclusion Criteria -Epilepsy

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).

Exclusion Criteria -Healthy:

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.

Exclusion Criteria- Epilepsy

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.

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


Responsible Party:	kmeador@stanford.edu, Professor, Emory University
ClinicalTrials.gov Identifier:	NCT02011971 History of Changes
Other Study ID Numbers:	IRB00044949 Emory Vinpocetine ( Other Identifier: Other )
Study First Received:	December 4, 2013
Last Updated:	August 2, 2016

Keywords provided by kmeador@stanford.edu, Emory 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

ClinicalTrials.gov processed this record on July 18, 2017