Investigative Treatment Providing Relief From Frozen Shoulder Enters Advanced Trials
Stony Brook seeks patients with the condition
STONY BROOK, N.Y., May 2, 2014 – An investigational drug developed by Stony Brook Medicine researchers for adhesive capsulitis, a painful condition more commonly known as “frozen shoulder,” has advanced to Phase 2b Food and Drug Administration (FDA) regulated clinical trials. Twenty-five centers across the U.S. and 10 in Australia are conducting these trials, including at Stony Brook. The Department of Orthopaedics at Stony Brook is seeking participants for the trial.
Frozen shoulder is painful and severely limits shoulder motion for an extended period of time, ranging from months to years. The condition affects three to five percent of the adult population. It affects more women than men and is more prevalent in individuals with diabetes, thyroid conditions, or those who have had mastectomies.
The research study involves injections of an enzyme called collagenase (collagenase clostridium histolyticum or CCH). The CCH drug used, was developed by researchers in the Department of Orthopaedics at Stony Brook Medicine. Marie A. Badalamente, PhD, Professor in the Department of Orthopaedics, and Edward Wang, MD, Associate Professor of Orthopaedics, Division of Shoulder, Elbow and Hand Surgery, were the first to develop the collagenase injection method for frozen shoulder and to patent the technology.
The current clinical trial offered by Stony Brook is designed to continue testing the use of the drug for frozen shoulder.
“Currently, treatment options for patients with frozen shoulder include cortisone injections, with or without extended physical therapy, which can be painful, physical therapy alone, or surgery,” said Dr. Wang. “We believe this investigational drug may reduce the pain caused by frozen shoulder and help to restore shoulder motion in a matter of months, instead of years.”
The drug was licensed to industry through Stony Brook’s Research Foundation and Office of License and Technology. After the completion of a Phase 1 clinical trial, in which Stony Brook Orthopaedics alone tested the injection therapy, a Phase 2a clinical trial of the drug was conducted at four centers across the U.S. Drs. Badalamente and Wang will present the results of these national trials at the American Orthopaedic Association and Canadian Orthopaedic Association combined meeting this this June.
“We have seen promising results from the earlier clinical trials of collagenase to treat frozen shoulder both from an efficacy and safety standpoint,” said Dr. Badalamente. “We encourage those in our region afflicted with this painful condition to participate in ongoing trials at Stony Brook.”
Eligibility criteria for the clinical trial include being age 18 or older, having frozen shoulder of only one shoulder with a duration of at least three months but no more than a year, and having no rotator cuff tears, arthritis or other shoulder problems. Interested individuals meeting these criteria may call 631-444-2215 about the details of the ongoing trial in the Department of Orthopaedics at Stony Brook.
This clinical trial for frozen shoulder lasts for three months for each participant. Compensation for volunteers is up to $275.
Participating in Approved Human Research Studies at Stony Brook
Stony Brook University supports medical advances for our patients through safe and ethical research involving volunteers from our surrounding community. Stony Brook University is accredited through the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), and has an approved assurance of compliance with the Federal Office for Human Research Protections. For more information on what it means to be a research subject, as well as how to participate in approved research studies conducted at Stony Brook University, please visit the Community/Research Participant Corner on the Stony Brook University website.