Phenytoin Cream for the Treatment of Neuropathic Pain
Status:
Recruiting
Trial end date:
2022-08-16
Target enrollment:
Participant gender:
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 72 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.
For the randomized cross-over trial phase, 48 DOBRET positive participants will enter the
DOBRET positive group and 24 DOBRET negative participants the DOBRET negative group.
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 72 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 from baseline NRS to the mean NRS in the second
week in DOBRET positive participants.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
David J. Kopsky
Collaborators:
Dr. C.J. Vaillant Fonds Princess Beatrix Muscle Foundation