Ketotifen for Joint Contracture

(PERK2 Trial)

Recruiting at 15 trial locations

Overseen By Gerardo Duque, MA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Calgary

Must not be taking: Oral hypoglycemics

Disqualifiers: Elbow arthritis, Epilepsy, Lactose intolerance, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

395 Participants Needed

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
• Lactose Placebo

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+