Pregabalin Treatment for RDEB Pain and Itch

PHASE3CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

August 7, 2019

Primary Completion Date

March 1, 2023

Study Completion Date

February 1, 2024

Conditions
Pain, NeuropathicItchEpidermolysis Bullosa
Interventions
DRUG

Pregabalin

Pregabalin /placebo capsules will be taken by mouth and will be prescribed for the study participants in the doses, depending on their weight and treatment phase: Participant \< 25 kg at baseline will start with 50 mg per day, increasing the dose by 50 mg each week until their maximum dose 200 mg per day; Participants who are greater than or equal to 25 kg at baseline will start with 100 mg per day, increasing their dose by 50 mg each week until their target dose 300 mg per day is achieved. The study medication will be taken twice per day.The dose will be weaned down every 1-2 days by 25 mg in the last two weeks of each treatment period.

Trial Locations (1)

M5G1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

Epidemolysis Bullosa Research Partnership

OTHER_GOV

lead

The Hospital for Sick Children

OTHER

NCT03928093 - Pregabalin Treatment for RDEB Pain and Itch | Biotech Hunter | Biotech Hunter