Dose Escalation Study of Vinpocetine in Healthy Volunteers

October 8, 2024 updated by: Kimford Jay Meador, Stanford University

Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers

The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy adults 18-40 years old.
  2. Proficient English.
  3. Use of appropriate contraception if woman of childbearing potential.

Exclusion Criteria:

  1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
  2. Those who score >18 overall on the BDI-II or >0 for item #9 (suicidal thoughts) at screening.
  3. Use of centrally active medications.
  4. History of allergy to vinpocetine.
  5. IQ<80.
  6. BMI≥30.
  7. Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: 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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)?

UNDECIDED

IPD Plan Description

Pending information from funding agency.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fetal Alcohol Spectrum Disorders

Clinical Trials on Vinpocetine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe