Dose Escalation Study of Vinpocetine in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vinpocetine.
- Who it may be relevant to
- Registry conditions: Fetal Alcohol Spectrum Disorders. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers
Overview
The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.
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.
Interventions
- Drug Vinpocetine
Increasing doses of vinpocetine to assess tolerability.
Primary outcome measures
- Adverse Events [Time frame: Approximately weekly treatments across ~4-6 visits per participant.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06635746 · Protocol: 77615 · R61AA031291