Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635746
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Dose Escalation Study of Vinpocetine in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Open Label Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 cognitivebehavioral 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 adolescentsadults with cognitive impairments from fetal alcohol or antiseizure medication eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None