EpilepsyPhase 1/2NCT02011971
Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy
A Phase 1/2 study testing Vinpocetine in people with Epilepsy, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Vinpocetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2026
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults (18-60 years old) with localization related epilepsy
- Patient is on stable antiepileptic drug therapy for last 2 months and is willing to remain on same therapy for the duration of the study.
- Proficient English
- Patient complains of memory problems.
- Neurological Disorders Depression Index -Epilepsy (NDDI-E) score <16
- Mini-Mental Status Exam (MMSE) score <22
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- No history of status epilepticus in last year
- No prior epilepsy surgeries
- Stable antiepileptic drug (AED) therapy for last 2 months or more and willing not to change for 2 months. Vinpocetine will be stopped and the patient will be withdrawn from the study if marked changes occur in seizures or if other adverse events occur.
- Use of appropriate contraception if woman of childbearing potential. This must include complete abstinence for the duration of the study or use of a barrier method plus one other contraceptive method (e.g. hormonal contraception or IUD).
Who cannot join
- Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression)
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
- Use of centrally active medications
- History of allergy to vinpocetine
- Scores onintelligence quotient (IQ) <80 or Medical College of Georgia (MCG) Paragraph score < 2 standard deviations below norm.
- Pregnancy or lactation.
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- Major medical disease (e.g., diabetes, heart disease, active cancer, depression)
- Use of centrally active medications
- History of allergy to vinpocetine
- Progressive Cerebral Disease (e.g., Alzheimer's disease)
- Aphasia
- Taking more than 3 AEDs
- Pregnancy or lactation
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Vinpocetine
- Keywords
- epilepsy, cognition, memory
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinpocetineDrug
Also called ethyl apovincaminate, ethyl apovincaminoate, eburnamenine-14-carboxylic acid ethyl ester, 3 alpha, 16 alpha-apovincaminic acid ethyl ester
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 drug
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Active comparator | Vinpocetine 10 mg Healthy subjects Receives: Drug: Vinpocetine |
| Mid-dose 1 | Active comparator | Vinpocetine 20mg Healthy subjects Receives: Drug: Vinpocetine |
| Placebo | Placebo comparator | 0 dose of vinpocetine Healthy and Epilepsy subjects Receives: Drug: Vinpocetine |
| High Dose | Active comparator | Vinpocetine 60 mg single dose Healthy Subjects \& 20mg tid Epilepsy Subjects Receives: Drug: Vinpocetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CNS Vitals Composite Score
CNS Vitals consists of multiple subtasks that provide an overall composite score will be the primary outcome measure
Measured: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12
Secondary outcomes (1)
Adverse Events
safety outcome
Measured: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: We are now considering revision of the IND to determine maximum tolerated dose
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind single dose crossover with 1-month follow-up open label in patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimford Jay Meador, Stanford University
- Investigators
- Kimford J Meador, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011971
- Sponsor's protocol ID
- IRB00044949
- Other IDs
- Stanford Vinpocetine
- Status last verified
- Aug 2024
- First submitted
- 4 Dec 2013
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT02011971
- Acronym / sponsor ID
- IRB00044949
- Conditions
- Epilepsy
- Keywords
- epilepsy, cognition, memory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: We are now considering revision of the IND to determine maximum tolerated dose
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2013 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind single dose crossover with 1-month follow-up open label in patients.
| Arm | Type | Receives |
|---|---|---|
| Low dose | Active comparator | Drug: VinpocetineVinpocetine 10 mg Healthy subjects |
| Mid-dose 1 | Active comparator | Drug: VinpocetineVinpocetine 20mg Healthy subjects |
| Placebo | Placebo comparator | Drug: Vinpocetine0 dose of vinpocetine Healthy and Epilepsy subjects |
| High Dose | Active comparator | Drug: VinpocetineVinpocetine 60 mg single dose Healthy Subjects \& 20mg tid Epilepsy Subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adults (18-60 years old) with localization related epilepsy
- Patient is on stable antiepileptic drug therapy for last 2 months and is willing to remain on same therapy for the duration of the study.
- Proficient English
- Patient complains of memory problems.
- Neurological Disorders Depression Index -Epilepsy (NDDI-E) score <16
Key exclusion criteria (14 listed)
- Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression)
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
- Use of centrally active medications
- History of allergy to vinpocetine
- Scores onintelligence quotient (IQ) <80 or Medical College of Georgia (MCG) Paragraph score < 2 standard deviations below norm.
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 |
|---|---|---|
| VinpocetineAlso: ethyl apovincaminate, ethyl apovincaminoate, eburnamenine-14-carboxylic acid ethyl ester, 3 alpha, 16 alpha-apovincaminic acid ethyl esterVinpocetine 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 drug | Drug | High Dose, Low dose, Mid-dose 1, Placebo |
Primary outcome
Change in CNS Vitals Composite Score
Time frame: 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
1 secondary outcome
Adverse Events
Time frame: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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.
Kimford J Meador, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vinpocetine in people with Epilepsy, run by Stanford University at 1 site in United States.
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 10 inclusion and 14 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: paused, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CNS Vitals Composite Score (time frame: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12). 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 16 Aug 2024.