Ketotifen for Joint Contracture
(PERK2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called Ketotifen, an antihistamine, to determine if it can improve movement after elbow injuries. Researchers aim to find out if Ketotifen enhances elbow mobility following a fracture or dislocation. Participants will take either a 2 mg or 5 mg dose of Ketotifen or a placebo (a pill with no active medicine) for six weeks. This trial is for adults who have recently had an elbow fracture or dislocation fixed with surgery and are ready to begin therapy within 21 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Ketotifen Fumarate is generally safe. Studies have found that most people tolerate it well, and past trials have reported no major safety issues. This medicine is already used to help prevent allergic reactions by stabilizing certain immune cells.
In tests with rabbits, Ketotifen Fumarate reduced joint stiffness without causing major side effects. While animal studies differ from human ones, they can provide an idea of what to expect.
Since this trial is in a late phase, earlier tests likely demonstrated that the treatment is safe enough for more participants. Overall, the research suggests the treatment is safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Ketotifen Fumarate for joint contracture because it offers a novel approach compared to typical treatments like physical therapy and surgery. Unlike these standard options, Ketotifen works by stabilizing mast cells and reducing inflammation, potentially addressing the underlying causes of joint stiffness. The study explores two doses, 2 mg and 5 mg, which could provide flexibility in managing the condition effectively. This oral medication could offer a simpler, less invasive treatment option, making it an appealing alternative for patients and healthcare providers alike.
What evidence suggests that this trial's treatments could be effective for joint contracture?
Research has shown that Ketotifen Fumarate may help reduce joint stiffness. In this trial, participants will receive either Ketotifen Fumarate at different dosages or a Lactose Placebo. Studies have found that Ketotifen significantly lessened joint stiffness compared to groups that did not receive the treatment. For instance, one study found that Ketotifen lowered the number of certain cells, called mast cells, which play a role in causing stiffness. Another study showed that higher doses of Ketotifen led to even less stiffness. Overall, Ketotifen appears effective in easing joint stiffness after injuries.25678
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