Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

Phase 1

Suspended

• Conditions: Epilepsy
• Interventions: Drug: Vinpocetine

• Registration Number: NCT02011971
• Lead Sponsor: Stanford University

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.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mid-dose 1	Vinpocetine	Vinpocetine 20mg Healthy subjects
Low dose	Vinpocetine	Vinpocetine 10 mg Healthy subjects
Placebo	Vinpocetine	0 dose of vinpocetine Healthy and Epilepsy subjects
High Dose	Vinpocetine	Vinpocetine 60 mg single dose Healthy Subjects \& 20mg tid Epilepsy Subjects

Primary Outcome Measures

Name	Time	Method
Change in CNS Vitals Composite Score	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

Name	Time	Method
Adverse Events	Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12	safety outcome

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States