Status:
COMPLETED
Efficacy and Safety of TenoMiR in Lateral Epicondylitis
Lead Sponsor:
Causeway Therapeutics
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of t...
Detailed Description
TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back t...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria.
- Subject has a clinical diagnosis of lateral epicondylitis.
- Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be retested once at the discretion of the Investigator.
- Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign).
- Subject's symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or combinations of:
- Physical therapy
- Splinting
- NSAIDs
Exclusion
- Subjects with any of the following will be excluded from study participation:
- Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
- Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration.
- Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
- Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics).
- Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
Key Trial Info
Start Date :
April 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2025
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT06192927
Start Date
April 10 2024
End Date
June 12 2025
Last Update
August 1 2025
Active Locations (9)
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1
Stanford Medicine
Redwood City, California, United States, 94063
2
Hospital for Special Surgery
New York, New York, United States, 10021
3
NYU Langone Health
New York, New York, United States, 10022
4
Panthera Biopartners
Enfield, United Kingdom, EN3 4GS