Clinical Trial Summaries > The Efficacy of Myalgesin™ for the Support of...

March 2006

ProThera®, Inc. received approval from the Western Institutional Review Board® (WIRB®) to initiate a clinical trial assessing the potential benefit of supplementation with the botanical preparation Mylagesin™ in maintaining normal joint function in patients with osteoarthritis of the knee. The principal investigator for the Phase II study is Stuart I. Erner, M.D., of the Capital Region Progressive Medicine and Longevity Center, Albany, New York.

The trial plans to recruit 100 people with symptomatic osteoarthritis of the knee over a 12 month period and randomize them to receive either acetaminophen or Myalgesin™. Patients will be followed clinically for 12 weeks. Osteoarthritis symptoms and functional impairment will be assessed at baseline and during follow-up using the Western Ontario and McMaster Universities (WOMAC™) Osteoarthritis Index and the Levesque Algofunctional Index.

The WOMAC™ is a multidimensional measure of pain, stiffness and physical function. It is widely accepted as the most useful disease-specific instrument for the assessment of knee and hip osteoarthritis. The WOMAC™ assesses symptoms and physical function during the 48 hours preceeding the test. The Lequesne Algofunctionality Index is designed to evaluate patient status at different stages in the natural history of osteoarthritis.

Osteoarthritis is the most common form of arthritis. It is more prevalent in women than men and becomes increasingly common with age. Approximately 50% of people over age 65 have osteoarthritis and 85% of people over the age of 75 are affected. Osteoarthritis is often a progressive disorder inflicting considerable pain and functional impairment. It is second only to heart disease as a leading cause of disability.

Currently available medical therapies do not effect the natural course of osteoarthritis, have limited ability to relieve symptoms and are associated with many side-effects, some quite serious. Safe, effective and economical alternative to standard therapies are needed. A botanical preparation such as Myalgesin™ is a viable supportive option to maintain normal joint function is people with osteoarthritis. The Mylagesin™ osteoarthritis trial will compare Myalgesin™ directly with acetaminophen, the presently recommended first line therapy for osteoarthritis. The study is designed to assess whether Myalgesin™ has a comparable or superior effect on symptoms and functional capacity.