What side effects are associated with this type of intervention?

Common treatments for Achilles tendinopathy involving peritendon injections include corticosteroids, platelet-rich plasma (PRP), and experimental agents like NGI226 MP. Known side effects of corticosteroid injections can include tendon weakening or rupture, skin discoloration, and localized pain. PRP injections may cause pain at the injection site, swelling, and, rarely, infection. For NGI226 MP, the study aims to measure safety and tolerability, but specific side effects are not detailed in the provided context.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for Achilles tendinopathy that involve peritendon injections aimed at improving tendon mechanical properties, such as NGI226 MP. Treatments like high volume injections and prolotherapy have been studied for tendinopathy, but their efficacy and approval status for Achilles tendinopathy remain unclear. Patients should consult with their healthcare provider for the most current and personalized treatment options.

What other types of research exist?

Promising novel alternatives to NGI226 MP for Achilles tendinopathy include: 1) Platelet-Rich Plasma (PRP) injections, which have shown positive effects in various tendinopathies, including lateral epicondylitis. 2) Autologous blood injections, which have been effective in treating medial epicondylitis. 3) Extracorporeal Shock Wave Therapy (ESWT), which has been beneficial for chronic tendon conditions like rotator cuff tendonitis. 4) Sclerosing polidocanol injections, which have shown promising results in pilot studies for chronic painful tendinopathies.

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NGI226 for Achilles Tendinopathy

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 169 (end of study)

Summary

This trial is testing an injection called NGI226 MP for people with a specific type of Achilles tendon injury. The goal is to see if this injection can make the injured tendon stronger and more flexible. Researchers will compare the results to ensure safety and effectiveness.

Who is the study for?

This trial is for individuals with mid-portion Achilles tendinopathy lasting over 8 weeks but less than a year, who haven't improved after at least 6 weeks of standard treatments like physiotherapy or NSAIDs. It's not suitable for those with conditions affecting injection safety, history of blood clots or frequent infections, past ankle surgeries or significant heart disease.

What is being tested?

The study is testing the safety and effectiveness of NGI226 Microparticles given as a single peritendon injection to improve Achilles tendon mechanical properties compared to a placebo in patients with Achilles tendinopathy.

What are the potential side effects?

While specific side effects are not listed, potential risks may include local reactions at the injection site such as pain, swelling, and irritation. Systemic side effects could occur but would depend on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 169 (end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 169 (end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 169 (end of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with AEs and SAEs

Secondary study objectives

Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NGI226Experimental Treatment1 Intervention

single peritendon injection

Group II: PlaceboPlacebo Group1 Intervention

single peritendon injection

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Achilles Tendinopathy, such as peritendon injections, aim to improve tendon mechanical properties and reduce pain. These injections often contain substances like corticosteroids, platelet-rich plasma (PRP), or investigational agents like NGI226 MP. The primary mechanism involves reducing inflammation, promoting tissue repair, and enhancing the structural integrity of the tendon. For Achilles Tendinopathy patients, this matters because improving tendon strength and flexibility can significantly reduce pain and improve function, facilitating a quicker return to daily activities and sports.