Dose Escalation Study of Vinpocetine in Healthy Volunteers
Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The planned study seeks to provide preliminary data to assess the benefits and safety for vinpocetine to address cognitive problems in two groups of patients. One group are patients with epilepsy in whom cognitive problems are common, but there is currently no specific treatment available. Vinpocetine has been shown to improve memory in animals and also has anticonvulsant activity. The other group are people who suffer cognitive/behavioral problems from fetal exposure to alcohol or anticonvulsant drugs. In animals, vinpocetine has been shown to mitigate these deficits. We propose to extend our prior preliminary studies by conducting a Phase I study in healthy volunteers, a Phase I study in adolescents with cognitive impairments from fetal alcohol exposure, then Phase II studies in patients with epilepsy and in adolescents/adults with cognitive impairments from fetal alcohol or antiseizure medication (e.g., valproate) exposure. The proposed investigations are guided by prior PK and PD studies in animals and humans. They are designed to provide data on the dosages needed to provide levels comparable to effective animal studies and provide data on the potential efficacy and safety of vinpocetine in improving cognition in order to direct more definitive randomized trials in the future.
Specific Aim: To determine the maximum tolerated oral dose of vinpocetine in healthy adult volunteers and develop data on pharmacokinetic response curve for vinpocetine effects.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jordan Seliger
- Phone Number: 650-460-9260
- Email: jseliger@stanford.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults 18-40 years old.
- Proficient English.
- Use of appropriate contraception if woman of childbearing potential.
Exclusion Criteria:
- Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
- Those who score >18 overall on the BDI-II or >0 for item #9 (suicidal thoughts) at screening.
- Use of centrally active medications.
- History of allergy to vinpocetine.
- IQ<80.
- BMI≥30.
- Pregnancy or lactation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vinpocetine
Participants will take increasing, single doses of vinpocetine.
|
Increasing doses of vinpocetine to assess tolerability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events
Time Frame: Approximately weekly treatments across ~4-6 visits per participant.
|
Safety Outcome
|
Approximately weekly treatments across ~4-6 visits per participant.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Fetal Diseases
- Pregnancy Complications
- Alcohol-Induced Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Fetal Alcohol Spectrum Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Phosphodiesterase Inhibitors
- Nootropic Agents
- Vinpocetine
Other Study ID Numbers
- Protocol: 77615
- R61AA031291 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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