A Phase 2 Multi-Centre Randomized Double-Blind Sham Controlled Proof of Concept Trial Evaluating the Efficacy and Safety of TenoMiR by Injection in Subjects with Lateral Epicondylitis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Lateral Epicondylitis
  • Age: Between 18 Year(s) - 65 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. No evidence of skeletal immaturity.
    2. Body mass index (BMI) of 18 to 35 kg/m2, inclusive, and weight ≥50 kg.
    3. Clinical diagnosis of lateral epicondylitis.
    4. Symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or more combinations of: Physical therapy, Splinting, and NSAIDs.
    5. Independent, ambulatory, and can comply with all post-injection evaluations and visits.

You may not be eligible for this study if the following are true:

    1. Has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrollment.
    2. Has received previous PRP injection to the affected elbow.
    3. Uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics).
    4. Has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
    5. Has a positive medical history of any of the following:
      • Medial epicondylitis
      • Radial tunnel syndrome
      • Carpal tunnel syndrome
      • Septic or gouty arthritis in the affected elbow within the previous 2 years prior to enrollment
      • Cervical radiculopathy within the previous 6 months prior to enrollment
      • Trauma to the affected elbow within the past 6 weeks
      • Neuromuscular or primary/secondary muscular deficiency, which limits the ability to perform functional measurement (e.g., grip strength test)
      • Coincidental rheumatologic, inflammatory diseases, including, but not limited to axial spondyloarthritis, psoriatic arthritis and rheumatoid arthritis
      • Osteoarthritis of the affected elbow
      • Fibromyalgia judged sufficient to compromise the evaluation of response
    6. Acute infection at the injection site.
    7. Use of tobacco and/or nicotine containing products (including e-cigarettes) within 90 days of dosing, until the end of the study.
    8. Subject has documented evidence of a history of (within the 12 months prior to screening for study entry) or current (e.g., liver testing) drug/alcohol abuse (>20 units/week).
    9. Taking high potency opioid analgesics, including but not limited to methadone, hydromorphone, and morphine or has documented positive drug urine test (cocaine, THC, opiates/opioids, benzodiazepines and amphetamines) on screening (excluding opiates) or Day 1 (all drugs of abuse).
    10. Strenuous exercise within 48 hours of screening and Day 1.
    11. Donation of blood or plasma of >400 mL within 4 weeks prior to dosing. Subjects must agree not to donate any blood or blood products for 4 weeks after dosing.
    12. Known difficulty with obtaining intravenous access.



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