Ketotifen for Joint Contracture

(PERK2 Trial)

Recruiting at15 trial locations

Overseen by Kevin A Hildebrand, MD, FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Calgary

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Research Team

Kevin A Hildebrand, MD, FRCSC

Principal Investigator

University of Calgary and Alberta Health Services

Eligibility Criteria

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

I have a fracture or dislocation in my elbow area.

I had surgery for an elbow fracture or dislocation.

Injury ≤ 10 days

Exclusion Criteria

I have a history of epilepsy.

Lactose intolerance

Language or Cognitive difficulties preventing reliable completion of questionnaires

Treatment Details

Interventions

• Ketotifen Fumarate (Antihistamine)
• Lactose Placebo (Drug)

Trial Overview The PERK 2 trial is testing the effectiveness of Ketotifen Fumarate at two different doses (2mg and 5mg) versus a placebo in improving movement range in the elbow after injury. It's a Phase III study where patients are randomly assigned to one of three groups and treated for six weeks.

Participant Groups

Group I: Ketotifen Fumarate - 5mg Active Control 2 Interventions

Ketotifen Fumarate 5 mg by mouth twice per day

Group II: Ketotifen Fumarate - 2mg Active Control 2 Interventions

Ketotifen Fumarate 2 mg by mouth twice per day

Group III: Lactose Placebo Placebo Group 1 Intervention

Lactose Placebo by mouth twice per day

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Dr. Shweta Patel

University of Calgary

Chief Medical Officer since 2020

MD from the University of Baroda Medical College, India

Dr. Edward McCauley

University of Calgary

President and Vice-Chancellor since 2018

PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences