395 Participants Needed

Ketotifen for Joint Contracture

(PERK2 Trial)

Recruiting at 15 trial locations
KA
GD
Overseen ByGerardo Duque, MA
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

KA

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

I have a fracture or dislocation in my elbow area.
I had surgery for an elbow fracture or dislocation.
Injury ≤ 10 days
See 2 more

Exclusion Criteria

I have a history of epilepsy.
Lactose intolerance
Language or Cognitive difficulties preventing reliable completion of questionnaires
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ketotifen 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including range of motion and adverse events

46 weeks

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Active Control
Placebo Group
Group I: Ketotifen Fumarate - 5mgActive Control2 Interventions
Group II: Ketotifen Fumarate - 2mgActive Control2 Interventions
Group III: Lactose PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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+
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