Ketotifen for Joint Contracture
(PERK2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) is a Phase III randomized, controlled, double blinded multicenter trial with 3 parallel groups (Ketotifen 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks) and a primary endpoint of elbow extension-flexion range of motion (ROM) arc at 12 weeks post-randomization.
Who Is on the Research Team?
Kevin A Hildebrand, MD, FRCSC
Principal Investigator
University of Calgary and Alberta Health Services
Are You a Good Fit for This Trial?
Adults over 18 with recent elbow injuries (fractures or dislocations) suitable for surgery, without prior elbow issues, severe kidney/liver problems, lactose intolerance, epilepsy, diabetes on oral medication, or pregnancy. Participants must be willing to use contraception and commit to follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ketotifen 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including range of motion and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Ketotifen Fumarate
- Lactose Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
United States Department of Defense
Collaborator