TenoMiR for Tennis Elbow

No longer recruiting at 9 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Causeway Therapeutics

Must not be taking: Pain medications, Glucocorticoids

Disqualifiers: Corticosteroid injection, PRP injection, surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called TenoMiR for treating tennis elbow, also known as lateral epicondylitis. TenoMiR aims to improve collagen quality, aiding in elbow repair and potentially offering a faster recovery than current treatments. The study will compare low and high doses of TenoMiR to a placebo injection (a saltwater solution) to better understand its effects. Individuals with tennis elbow symptoms lasting 6 weeks to 9 months, who haven't found relief with standard treatments like physical therapy or anti-inflammatory medications, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking pain medications like opiates or NSAIDs at least 1 week before starting the trial. If you are using medications that affect the skeleton, you may also need to stop those.

Will I have to stop taking my current medications?

You will need to stop taking pain medications like opiates or NSAIDs at least one week before starting the trial. If you are using medications that affect the skeleton, you may also need to stop those.

Is there any evidence suggesting that TenoMiR is likely to be safe for humans?

Research has shown that TenoMiR has been tested in people and is safe and well-tolerated. In earlier studies, patients experienced noticeable improvements in their condition without serious side effects. These results suggest that TenoMiR could be a promising and safe treatment option for those with tennis elbow. As a Phase 2 study, the treatment has already passed initial safety tests, but more participants are needed to confirm these findings. So far, the data appears encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tennis elbow?

Unlike the standard treatments for tennis elbow, which typically include physical therapy, steroid injections, or anti-inflammatory medications, TenoMiR offers a novel approach by using a mimic of the microRNA miR29a. This treatment is unique because it is administered as an intralesional injection directly into the tendon, potentially enhancing its effectiveness. Researchers are excited about TenoMiR because it targets the cellular processes involved in tendon repair, potentially offering a quicker recovery compared to conventional methods.

What evidence suggests that TenoMiR might be an effective treatment for tennis elbow?

Research has shown that TenoMiR, which participants in this trial may receive, may help treat tennis elbow. In earlier studies, patients who took TenoMiR experienced noticeable improvements in pain, movement, and tendon health. These changes were not just by chance. TenoMiR improves collagen quality, aiding in elbow repair. Early results suggest that TenoMiR is safe and easy to use, making it a promising option for those seeking relief from tennis elbow. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with tennis elbow who are otherwise healthy. They must have symptoms like tenderness at the lateral epicondyle and a positive 'pick up back of chair' sign, despite treatments like splinting, NSAIDs, or physical therapy.

Inclusion Criteria

My symptoms appear when I twist my forearm or bend my wrist back.

Subject is otherwise healthy as determined by a responsible physician

My symptoms have lasted 6 weeks to 6 months despite trying physical therapy, splinting, and NSAIDs.

Exclusion Criteria

I can stop taking pain medication a week before starting the trial medication.

I have had a Platelet-Rich Plasma injection in my elbow.

I use or recently used medication that affects my bones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intralesional injection of TenoMiR or a sham comparator

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, disability, and tendon integrity

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• TenoMiR

Trial Overview

The study tests TenoMiR, a new drug aimed at improving collagen quality to repair elbow damage. It's compared against a saline injection (placebo). The goal is to offer an effective treatment right after diagnosis for quicker recovery.

How Is the Trial Designed?

Group I: TenoMiR intralesional injection Experimental Treatment 1 Intervention

Drug: TenoMiR (Low Dose), Single injection Mimic of miR29a Other Names: • CWT-001 Drug: TenoMiR (High Dose), Single injection Mimic of miR29a Other Names: • CWT-001

Group II: 0.9% saline subcutaneous sham injection Placebo Group 1 Intervention

Drug: 0.9% saline Subcutaneous single injection

Who Is Running the Clinical Trial?

Causeway Therapeutics

Lead Sponsor

Trials

2

Recruited

150+

Published Research Related to This Trial

In a study of 48 patients with chronic lateral epicondylitis, both kinesiotaping (KT) and sham taping significantly improved pain and arm function, indicating that both methods can provide relief.

However, there was no significant difference in effectiveness between the KT and sham groups, suggesting that the benefits of KT may not be superior to a placebo effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of kinesiotaping on wrist extensor strength using an isokinetic device in patients with chronic lateral epicondylitis: A randomized-controlled trial. Tezel, N., Can, A., Karaahmet, Ö., et al.[2022]

A study of 267 new cases of tennis elbow found that manual job tasks significantly increase the risk of developing the condition, with an odds ratio of 3.1, indicating a strong association with physical strain factors like posture and forceful work.

Women with low social support at work were found to have a higher risk of tennis elbow (odds ratio 2.4), highlighting the importance of psychosocial factors alongside physical risks in the development of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and psychosocial risk factors for lateral epicondylitis: a population based case-referent study. Haahr, JP., Andersen, JH.[2019]

The Greek version of the Patient-Rated Tennis Elbow Evaluation (PRTEE-G) Questionnaire has been validated as a reliable tool for assessing Lateral Elbow Tendinopathy (LET) in 82 patients, showing excellent test-retest reliability (ICC = 0.94).

The PRTEE-G demonstrated strong internal consistency (Cronbach's alpha = 0.95) and good concurrent validity when correlated with the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), indicating it effectively measures the impact of LET on patients' daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greek adaptation and validation of the Patient-Rated Tennis Elbow Evaluation (PRTEE). Stasinopoulos, D., Papadopoulos, C., Antoniadou, M., et al.[2015]

In a study involving 27 participants with lateral elbow tendinopathy, the application of tensioned multidirectional elastic tape did not show statistically significant improvements in pain-free grip strength or pressure pain threshold compared to control conditions.

Despite the overall lack of significant results, 26% of participants did experience an increase in pain-free grip strength after using the elastic tape, suggesting that individual responses may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multidirectional elastic tape on pain and function in individuals with lateral elbow tendinopathy: A randomised crossover trial. Hill, CE., Heales, LJ., Stanton, R., et al.[2023]

A study involving 24 tennis players showed that different racket constructions can significantly affect arm vibrations during play, with some rackets reducing vibrations by nearly threefold, which may help prevent conditions like tennis elbow.

Factors such as body weight and skill level also influence vibration levels, with less skilled players experiencing higher vibration loads, indicating that both equipment choice and player experience are important in managing arm stress during tennis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfer of tennis racket vibrations onto the human forearm. Hennig, EM., Rosenbaum, D., Milani, TL.[2004]

The patient-related forearm evaluation questionnaire (PRFEQ) demonstrated excellent test-retest reliability for assessing pain and function in patients with lateral epicondylitis, with overall reliability scores of ICC 0.89 for the full questionnaire and ICC 0.83 for the function subscale.

While the PRFEQ is a reliable tool for evaluating forearm pain and function, its large standard error of measurement and confidence intervals suggest it may not accurately predict individual patient scores, particularly for those with work-related lateral epicondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of a patient-rated forearm evaluation questionnaire for patients with lateral epicondylitis. Overend, TJ., Wuori-Fearn, JL., Kramer, JF., et al.[2019]

This study recorded 662 musculoskeletal injuries among 485 real tennis players, revealing an incidence rate of 0.4 injuries per 1000 hours of play, with the elbow, knee, and face being the most commonly injured areas.

The majority of upper limb injuries were gradual in onset, while lower limb injuries were often sudden, indicating different injury mechanisms that could inform prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal injuries in real tennis. Humphrey, JA., Humphrey, PP., Greenwood, AS., et al.[2020]

The Marcy Wedge-Pro (MWP) device effectively measures wrist extension exercises in patients with tennis elbow, a common condition characterized by pain during this activity.

The MWP demonstrated a significant ability to accurately identify patients who responded to treatment, suggesting it could be a valuable tool for quantitatively assessing tennis elbow outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of tennis elbow using the Marcy Wedge-Pro. Smith, RW., Mani, R., Cawley, MI., et al.[2019]

In a study of 128 patients with tennis elbow, the treatment group receiving electroacupuncture and moxibustion showed a higher cure rate (40.6%) and effective rate (93.7%) compared to the control group treated with lidocaine and prednisone (cure rate of 25.0% and effective rate of 78.1%).

The results indicate that electroacupuncture combined with moxibustion is a more effective treatment option for tennis elbow than conventional steroid injections, suggesting a promising alternative for patients seeking relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Controlled observation on electroacupuncture combined with cake-separated moxibustion for treatment of tennis elbow]. Jiang, ZY., Li, CD., Guo, JH., et al.[2018]

In a study of 83 patients undergoing 8 weeks of physical therapy for lateral epicondylitis, it was found that women and those reporting nerve symptoms had poorer outcomes, as measured by the DASH questionnaire and pain visual analog scale.

Factors such as work-related onset, repetitive keyboarding jobs, and cervical joint signs were particularly influential in predicting worse outcomes for women, highlighting the need for tailored interventions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with prognosis of lateral epicondylitis after 8 weeks of physical therapy. Waugh, EJ., Jaglal, SB., Davis, AM., et al.[2019]

In a study of 54 patients with tennis elbow, the addition of a high-frequency vibration device (Tenease™) to standard treatment did not show statistically significant improvements in pain and function compared to standard treatment alone after 6 months.

Both treatment groups experienced improvements in their condition, but the Tenease group did not outperform the standard treatment group, and the study faced challenges such as a high dropout rate and a small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration therapy versus standard treatment for tennis elbow: A randomized controlled study. Furness, ND., Phillips, A., Gallacher, S., et al.[2019]

In a study of 24 adult patients with lateral epicondylitis who did not respond to other treatments, ultrasound-guided injections of incobotulinumtoxinA significantly reduced pain and improved upper-limb functionality over 6 months, with results showing improvement at all follow-up points (p < 0.001).

The treatment was found to be safe, with no serious adverse events reported, aside from expected mild weakness in the third finger, indicating that incobotulinumtoxinA could be a viable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Ultrasound-Guided Administration of Botulinum Toxin (IncobotulinumtoxinA) in Patients with Lateral Epicondylitis. Galván Ruiz, A., Vergara Díaz, G., Rendón Fernández, B., et al.[2020]

Patients with chronic unilateral tennis elbow exhibited significantly slower reaction times (19% to 36% slower) and reduced speed of movement (31% to 32% slower) in their arms compared to age- and gender-matched controls, indicating impaired motor performance.

Interestingly, the healthy arms of the patients also showed slower reaction times and movement speed compared to the controls, suggesting that the effects of chronic tennis elbow may extend beyond the injured arm, potentially indicating a broader motor performance issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilaterally decreased motor performance of arms in patients with chronic tennis elbow. Pienimäki, TT., Kauranen, K., Vanharanta, H.[2019]

The simulation model revealed that off-centre impacts during one-handed tennis backhands can significantly increase wrist flexion and extension torque, potentially leading to injuries like tennis elbow.

A tighter grip on the racquet during off-centre impacts exacerbates these effects, resulting in less racquet rotation and increased wrist extension torque, highlighting the importance of grip technique in injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of ball impact location and grip tightness on the arm, racquet and ball for one-handed tennis backhand groundstrokes. King, MA., Kentel, BB., Mitchell, SR.[2012]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06192927

Efficacy and Safety of TenoMiR in Lateral Epicondylitis

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis).

2.

causewaytx.com

causewaytx.com/october_28_2025_pr

10-28-25 – Causeway Therapeutics Debuts Positive Data ...

Data Show Statistically Significant Improvements in Pain, Function and Tendon Structure in Appropriately Dosed Patients.

3.

gla.ac.uk

gla.ac.uk/news/headline_1222823_en.html

Causeway Therapeutics hails clinical study boost

"The results of this TenoMiR trial are highly encouraging for the treatment of tendinopathy,” said Scott Rodeo, MD, Professor, Orthopaedic ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04670289

Study Details | NCT04670289 | Safety, Tolerability, and ...

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 ...

5.

trialx.com

trialx.com/clinical-trials/listings/289374/efficacy-and-safety-of-tenomir-in-lateral-epicondylitis/

Efficacy and Safety of TenoMiR in Lateral Epicondylitis

Overview. This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis).

6.

globenewswire.com

globenewswire.com/news-release/2025/10/28/3175220/0/en/Causeway-Therapeutics-Debuts-Positive-Data-from-Phase-2-Clinical-Trial-of-TenoMiR-for-Lateral-Epicondylitis.html

Causeway Therapeutics Debuts Positive Data from Phase 2

“Based on our promising Phase 2 data in lateral epicondylitis, I am confident that TenoMiR has the potential to be game-changing for patients,” ...