Fetal Alcohol Spectrum DisordersPhase 1NCT06635746
Dose Escalation Study of Vinpocetine in Healthy Volunteers
A Phase 1 study testing Vinpocetine in people with Fetal Alcohol Spectrum Disorders, run by Stanford University.
Trial summary
The objective of this study is to determine whether vinpocetine is safe when taken at higher doses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Vinpocetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 18-40 years old.
- Proficient English.
- Use of appropriate contraception if woman of childbearing potential.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Vinpocetine
- Keywords
- Cognition, Vinpocetine
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinpocetineDrug
Increasing doses of vinpocetine to assess tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Vinpocetine | Experimental | Participants will take increasing, single doses of vinpocetine. Receives: Drug: Vinpocetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety Outcome
Measured: Approximately weekly treatments across ~4-6 visits per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kimford Jay Meador, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635746
- Sponsor's protocol ID
- Protocol: 77615
- Other IDs
- R61AA031291
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending information from funding agency.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06635746
- Acronym / sponsor ID
- Protocol: 77615
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- Cognition, Vinpocetine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vinpocetine | Experimental | Drug: VinpocetineParticipants will take increasing, single doses of vinpocetine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults 18-40 years old.
- Proficient English.
- Use of appropriate contraception if woman of childbearing potential.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinpocetineIncreasing doses of vinpocetine to assess tolerability. | Drug | Vinpocetine |
Primary outcome
Adverse Events
Time frame: Approximately weekly treatments across ~4-6 visits per participant.
Safety Outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: Undecided. Pending information from funding agency.
Related trials for Fetal Alcohol Spectrum Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vinpocetine in people with Fetal Alcohol Spectrum Disorders, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Seliger (650-460-9260, jseliger@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Approximately weekly treatments across ~4-6 visits per participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.