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Ngi226

A new clinical trial is exploring the potential of NGI226 microparticles as a treatment for Achilles tendinopathy. This study aims to evaluate the safety, tolerability, and preliminary effectiveness of NGI226 when administered as a single peritendon injection. The trial compares NGI226 to a placebo in patients suffering from mid-portion Achilles tendinopathy, focusing on both local and systemic effects, as well as improvements in tendon mechanical properties.

Table of Contents

What is NGI226?

NGI226 is an experimental drug currently being studied for its potential in treating Achilles tendinopathy[1]. It is formulated as microparticles (MP), which are tiny particles designed to deliver the medication effectively to the targeted area. The exact mechanism of how NGI226 works is not fully disclosed in the available information, but it is being investigated for its ability to aid in tendon regeneration.

What Condition Does NGI226 Target?

NGI226 is specifically being studied for the treatment of Achilles tendinopathy[1]. Achilles tendinopathy is a condition that affects the Achilles tendon, which is the large tendon connecting your calf muscles to your heel bone. This condition is characterized by pain, swelling, and stiffness in the Achilles tendon, often resulting from overuse or injury. It can significantly impact a person’s ability to walk, run, or participate in physical activities.

Current Clinical Trial

NGI226 is currently being evaluated in a clinical trial to assess its safety, tolerability, and preliminary efficacy in patients with Achilles tendinopathy[1]. The study is designed as follows:

  • Type of study: It is a randomized, participant and investigator-blinded, 2-arm, parallel-design, placebo-controlled study. This means that participants are randomly assigned to either receive NGI226 or a placebo, and neither the participants nor the investigators know who is receiving which treatment.
  • Masking: The study is blinded, meaning that participants, care providers, investigators, and outcomes assessors are not aware of which treatment each participant is receiving. This helps to prevent bias in the results[1].
  • Comparison: The study compares NGI226 microparticles to placebo microparticles to determine if NGI226 offers any benefits over a placebo treatment[1].

How is NGI226 Administered?

In the clinical trial, NGI226 is administered as a single peritendon injection[1]. This means that the medication is injected around the tendon, specifically in the area surrounding the Achilles tendon. This method of administration is designed to deliver the medication directly to the affected area.

Safety and Efficacy Evaluation

The primary focus of the current study is to assess the safety and tolerability of NGI226. The researchers are monitoring several aspects:

  • Adverse Events (AEs) and Serious Adverse Events (SAEs): These are any unintended or harmful effects that occur during the study period[1].
  • ECG parameters: This involves monitoring the electrical activity of the heart to ensure the treatment doesn’t cause any cardiac issues.
  • Laboratory tests: This includes chemistry and hematology parameters, which involve analyzing blood samples for various markers of health and potential side effects.
  • Urinalysis: This involves examining urine samples for any signs of adverse effects.
  • Local tolerability: This refers to how well the injection site tolerates the treatment, checking for any local reactions or issues[1].

The study will monitor these safety aspects for up to 169 days (about 5.5 months) after the treatment[1].

Potential Benefits of NGI226

While the primary focus of the current study is on safety, the researchers are also looking at potential benefits of NGI226. One key aspect they’re investigating is the effect of NGI226 on tendon stiffness[1]. They will use a technique called ultrasound-based shear wave elastography (SWE) to measure changes in tendon stiffness from the start of the study to 12 weeks after treatment.

The goal is to see if NGI226 can help restore the biomechanical integrity of the Achilles tendon. In simpler terms, they’re checking if the treatment can help the tendon regain its normal flexibility and strength. This could potentially lead to improvements in symptoms and function for people with Achilles tendinopathy[1].

Aspect Details
Study Title Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy
Condition Achilles Tendinopathy
Treatment Single peritendon injection of NGI226 microparticles vs. placebo
Primary Outcome Number of participants with adverse events and serious adverse events
Secondary Outcome Changes in tendon stiffness from baseline at week 12
Assessment Method Ultrasound-based shear wave elastography (SWE)
Study Duration Up to 169 days (End of Study)
Masking Participant and Investigator-blinded, including outcomes assessor

FAQ

  • What is NGI226 and how is it being used in this clinical trial? NGI226 is a microparticle-based treatment being investigated for Achilles tendinopathy. In this trial, it's administered as a single peritendon injection, which means it's injected near the Achilles tendon.
  • What is the main purpose of this clinical trial? The main purpose is to evaluate the safety, tolerability, and preliminary efficacy of NGI226 microparticles compared to a placebo in patients with Achilles tendinopathy. The study will assess both local and systemic effects, as well as improvements in tendon mechanical properties.
  • How long does the study last? The study lasts up to 169 days (about 24 weeks) from the start of treatment to the end of the study.
  • What are the primary outcomes being measured in this trial? The primary outcomes focus on safety and tolerability. The researchers will track the number of participants experiencing adverse events (AEs) and serious adverse events (SAEs), including changes in ECG parameters, lab chemistry and hematology values, urinalysis results, and local tolerability.
  • How will the effectiveness of NGI226 be measured? The effectiveness will be assessed by measuring changes in tendon stiffness from baseline to week 12 using ultrasound-based shear wave elastography (SWE). This technique helps evaluate the restoration of biomechanical integrity in the Achilles tendon.

Ongoing Clinical Trials on Ngi226

  • Study on the Safety and Effects of NGI226 Microparticles for Patients with Achilles Tendinopathy

    Not recruiting

    2 1
    Investigated drugs:
    France Germany The Netherlands

Glossary

  • Achilles Tendinopathy: A condition characterized by pain, swelling, and reduced function of the Achilles tendon, which connects the calf muscles to the heel bone.
  • Peritendon Injection: An injection administered near or around a tendon, in this case, the Achilles tendon.
  • Microparticles (MP): Tiny particles, often used in medical treatments to deliver drugs or other therapeutic substances to specific areas of the body.
  • Placebo: A substance with no active medical properties, used as a control in clinical trials to compare against the effects of the investigational treatment.
  • Adverse Events (AEs): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it's related to the treatment being studied.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, cause persistent disability, or have other significant medical consequences.
  • ECG (Electrocardiogram): A test that records the electrical activity of the heart to check for various heart conditions.
  • Shear Wave Elastography (SWE): An ultrasound-based imaging technique used to measure the stiffness or elasticity of soft tissues, such as tendons.
  • Biomechanical Integrity: The structural and functional soundness of a biological tissue, in this case, the Achilles tendon's ability to withstand and transmit forces effectively.

References

  1. https://clinicaltrials.gov/study/NCT05592990