Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647877
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2020-11-16
Brief Title:
Phenytoin Cream for the Treatment of Neuropathic Pain
Sponsor:
David J Kopsky
Organization:
UMC Utrecht
Study Overview
Official Title:
Enrichment Randomized Double-blind Placebo-controlled Cross-over Trial With PHEnytoin Cream in Patients With Painful Chronic Idiopathic Axonal polyNEuropathy
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPHENE
Brief Summary:
Objectives The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to chronic idiopathic axonal polyneuropathy CIAP The second objective is to determine the predictive value of a double-blind placebo-controlled response test DOBRET to identify sustained responders
Study design This is a 6-week enrichment randomized double-blind placebo-controlled cross-over trial evaluating phenytoin cream in 84 participants with painful CIAP whereafter an open label extension phase is offered with phenytoin 20 percent cream for up to one year
At baseline a DOBRET with phenytoin 10 percent and placebo cream will be performed in each study participant to stratify participants according to their response to the DOBRET before entering the double-blind cross-over phase DOBRET positive participants are those who experience at least two points pain reduction on the 11-point numerical rating scale NRS on the phenytoin 10 percent cream applied area within 30 minutes and at least one-point difference in pain reduction on the NRS between phenytoin 10 percent and placebo cream applied area in favour of the former
Participants will receive three treatments in a double blind fashion and in a randomized order phenytoin 10 percent phenytoin 20 percent and placebo cream The duration of each treatment period is two weeks Participants will cross-over two times to each of the other treatments The study does not have wash-out periods between treatments because the mean duration of analgesic effect after an application is expected to be less than nine hours A blood sample will be collected at the end of the second week of the first treatment period to test for phenytoin plasma levels
Study population The investigators aim to include 84 participants age 40 years or older who have been diagnoses with painful CIAP at the University Medical Center Utrecht and fulfil the inclusion criteria and have given written informed consent
Interventions Phenytoin cream in concentrations of 10 percent and 20 percent cream compared to placebo cream
Primary endpoint Change in pain intensity measured on the NRS between baseline and week 2 for phenytoin 20 cream versus placebo cream
Study design This is a 6-week enrichment randomized double-blind placebo-controlled cross-over trial evaluating phenytoin cream in 84 participants with painful CIAP whereafter an open label extension phase is offered with phenytoin 20 percent cream for up to one year
At baseline a DOBRET with phenytoin 10 percent and placebo cream will be performed in each study participant to stratify participants according to their response to the DOBRET before entering the double-blind cross-over phase DOBRET positive participants are those who experience at least two points pain reduction on the 11-point numerical rating scale NRS on the phenytoin 10 percent cream applied area within 30 minutes and at least one-point difference in pain reduction on the NRS between phenytoin 10 percent and placebo cream applied area in favour of the former
Participants will receive three treatments in a double blind fashion and in a randomized order phenytoin 10 percent phenytoin 20 percent and placebo cream The duration of each treatment period is two weeks Participants will cross-over two times to each of the other treatments The study does not have wash-out periods between treatments because the mean duration of analgesic effect after an application is expected to be less than nine hours A blood sample will be collected at the end of the second week of the first treatment period to test for phenytoin plasma levels
Study population The investigators aim to include 84 participants age 40 years or older who have been diagnoses with painful CIAP at the University Medical Center Utrecht and fulfil the inclusion criteria and have given written informed consent
Interventions Phenytoin cream in concentrations of 10 percent and 20 percent cream compared to placebo cream
Primary endpoint Change in pain intensity measured on the NRS between baseline and week 2 for phenytoin 20 cream versus placebo cream
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None