EG110A for Neurogenic Detrusor Overactivity

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: EG 427

Disqualifiers: Tumor, Malignancy, Active herpes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it seems that participants should have been on a stable treatment for Neurogenic Detrusor Overactivity for at least 3 months before joining the trial.

What data supports the effectiveness of the drug EG110A for treating neurogenic detrusor overactivity?

The research shows that treatments like botulinum toxin A, which is similar to EG110A, have been effective in treating neurogenic detrusor overactivity by reducing symptoms and improving bladder control.

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What safety data exists for EG110A in treating neurogenic detrusor overactivity?

The safety of treatments similar to EG110A, like abobotulinumtoxinA and incobotulinumtoxinA, has been studied in patients with neurogenic detrusor overactivity, showing they are generally safe for human use.

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Eligibility Criteria

This trial is for adults with bladder control issues due to nerve damage from a spinal cord injury, who still have incontinence despite standard treatments and regularly use a catheter. Participants must be stable post-injury and able to attend all study visits.

Inclusion Criteria

I have had urinary incontinence due to nerve damage for at least 3 months.

My spinal cord injury is stable and happened over a year ago.

I have tried treatments for NDO without success or had side effects, and I'm not considering BoNT/A or surgery next.

Exclusion Criteria

I do not currently have active oral or genital herpes, or it has been treated and fully healed.

I had cancer treatment within the last 4 weeks and still have side effects.

I have a tumor or cancer affecting my spine or have another cause for spinal cord injury.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single treatment course consisting of multiple intradetrusor injections of EG110A

12 weeks

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including urodynamic assessments and bladder diary evaluations

52 weeks

Regular follow-up visits for assessments

Participant Groups

The study tests multiple doses of EG110A, given via bladder injections, to see if it can help with incontinence caused by neurogenic detrusor overactivity following spinal cord injury. It's an early-phase trial to find the right dose.

Group I: EG110A (low dose) Experimental Treatment 1 Intervention

Patients who Received EG110A (low dose)

Group II: EG110A (Middle Dose) Experimental Treatment 1 Intervention

Patients who Received EG110A (middle dose)

Group III: EG110A (High Dose) Experimental Treatment 1 Intervention

Patients who Received EG110A (high dose)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rancho Los Amigos National Rehabilitation Center Downey, CA

Sidney Kimmel Medical College Philadelphia, PA

TIRR Memorial Hermann Houston, TX

University of Michigan Rogel Cancer Center Ann Arbor, MI

More Trial Locations

Who Is Running the Clinical Trial?

EG 427 Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Intravesical oxybutynin therapy for patients with neurogenic detrusor overactivity: a systematic review and meta-analysis. [2022] To evaluate the effectiveness and safety of intravesical oxybutynin therapy for patients with neurogenic detrusor overactivity.

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport® (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. [2022] Assess the efficacy and safety of abobotulinumtoxinA (Dysport®) in adult patients with neurogenic detrusor overactivity (NDO).

3. United States pubmed.ncbi.nlm.nih.gov

Is repeat Botulinum Toxin A injection valuable for neurogenic detrusor overactivity-A systematic review and meta-analysis. [2019] To investigate the value of repeat botulinum toxin A (BTX-A) injections in patients with neurogenic detrusor overactivity (NDO).

4. France pubmed.ncbi.nlm.nih.gov

Switching from onabotulinum toxin A to abobotulinum toxin A for treating detrusor overactivity in spinal cord injured patient, does it really work? [2023] To assess the efficacy of switching to Abobotulinumtoxin A (ATA) intradetrusor injections (IDI) after failure of Onabotulinumtoxin A (OTA) IDI for the treatment of neurogenic detrusor overactivity in patients with spinal cord injury (SCI).

5. Germany pubmed.ncbi.nlm.nih.gov

Treatment outcomes and resource use of patients with neurogenic detrusor overactivity receiving botulinum toxin A (BOTOX) therapy in Germany. [2021] To evaluate treatment outcomes and resource consumption of patients with neurogenic detrusor overactivity (NDO) before and after botulinum toxin A (Botox) therapy in Germany.

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. [2007] We evaluated the efficacy, tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome.

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. [2013] We evaluated the efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity.

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of extended release oxybutynin for the treatment of urge incontinence: an analysis of data from 3 flexible dosing studies. [2019] We assessed the efficacy and safety of extended release (ER) oxybutynin at individualized doses for urge urinary incontinence.

9. Canada pubmed.ncbi.nlm.nih.gov

The intravesical injection of highly purified botulinum toxin for the treatment of neurogenic detrusor overactivity. [2021] We aimed to assess safety and efficacy of incobotulinumtoxinA for the treatment of neurogenic detrusor overactivity (NDO).