EG110A for Neurogenic Detrusor Overactivity

Recruiting at 4 trial locations

Overseen By Cornelia Haag-Molkenteller, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: EG 427

Disqualifiers: Tumor, Malignancy, Active herpes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EG110A for individuals with bladder control issues due to nerve damage from a spinal cord injury. The researchers aim to determine the optimal dose of EG110A by administering low, middle, or high doses to different groups to identify the most effective one. Participants should have experienced frequent bladder leaks (at least 8 times a week) despite other treatments and should regularly use Clear Intermittent Catheterization to manage their condition. As a Phase 1/Phase 2 trial, this research focuses on understanding how EG110A works in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that EG110A is likely to be safe for humans?

Research has shown that EG110A has promising safety results from early studies. Specifically, participants tolerated the low dose of EG110A well, with no widespread side effects reported. This suggests any side effects were likely mild and did not affect the whole body.

The study also found that this treatment significantly reduced episodes of urinary incontinence by over 88% in some patients. This indicates that EG110A is not only potentially effective but also safe for individuals with bladder control issues due to nerve damage.

This trial is in the early stages, focusing mainly on ensuring EG110A's safety for humans. Safety remains a top priority, and the findings so far are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Neurogenic Detrusor Overactivity?

Researchers are excited about EG110A because it offers a potentially novel approach to managing neurogenic detrusor overactivity (NDO). While current treatments like anticholinergics focus on blocking certain receptors to reduce bladder contractions, EG110A might work differently by precisely targeting the pathways responsible for overactive bladder signals. This could lead to fewer side effects and improved efficacy. Additionally, the trial explores varying doses (high, middle, and low), which could help identify the optimal balance between effectiveness and tolerability, offering more personalized treatment options for patients.

What evidence suggests that EG110A might be an effective treatment for Neurogenic Detrusor Overactivity?

Research has shown that EG110A may help treat neurogenic detrusor overactivity (NDO), a condition causing bladder control problems, often after a spinal cord injury. Early results from previous studies found that even at the lowest dose, EG110A reduced incontinence by over 88%. This trial will test EG110A at various doses—low, middle, and high—to evaluate its effectiveness. Higher doses appear to enhance its efficacy, offering hope for improved bladder management for those with ongoing symptoms. Overall, EG110A is emerging as a strong option for improving bladder control in people with NDO. ^{4 6 7 8 9}

Who Is on the Research Team?

Cornelia Haag-Molkenteller, MD

Principal Investigator

EG 427

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• EG110A

Trial Overview 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.

How Is the Trial Designed?

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)

Who Is Running the Clinical Trial?

EG 427

Lead Sponsor

Trials

1

Recruited

20+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

Intravesical oxybutynin therapy significantly increased maximum bladder capacity in both children (77.8 ml) and adults (110.8 ml), indicating its effectiveness in treating neurogenic detrusor overactivity.

The treatment was generally safe, with 76.9% of adults and 74.6% of children reporting improvement or being dry after therapy, although 13.5% experienced side effects, and 20.4% discontinued treatment for various reasons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical oxybutynin therapy for patients with neurogenic detrusor overactivity: a systematic review and meta-analysis. Shen, SH., Jia, X., Peng, L., et al.[2022]

In a study involving 420 patients with urge urinary incontinence, individualized dosing of extended-release oxybutynin led to a significant reduction in incontinence episodes, with an average decrease of 79.3% in total episodes and 83.2% in urge episodes.

The treatment was well tolerated, with 81% of patients experiencing at least a 70% reduction in incontinence episodes and 43% achieving total dryness, although 23% reported moderate to severe dry mouth as a side effect.

NCBI (Pubmed)

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. MacDiarmid, SA., Anderson, RU., Armstrong, RB., et al.[2019]

In a pilot study of 17 male patients with neurogenic detrusor overactivity, incobotulinumtoxinA injections led to significant improvements in daily urinary frequency (from 9.4 to 4.6) and daily incontinence episodes (from 2.5 to 0.4), indicating its efficacy in managing symptoms of urgency incontinence.

No serious safety concerns were reported, as there were no urinary tract infections or new urinary retention cases within 30 days post-injection, suggesting that incobotulinumtoxinA is a safe treatment option for neurogenic bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The intravesical injection of highly purified botulinum toxin for the treatment of neurogenic detrusor overactivity. Asafu-Adjei, D., Small, A., McWilliams, G., et al.[2021]

In a study of 214 patients with neurogenic detrusor overactivity (NDO), Botox therapy significantly improved bladder function, as shown by increased maximum detrusor pressure and capacity, and reduced urinary incontinence episodes.

Post-treatment, the incidence of urinary tract infections (UTIs) and the use of incontinence aids dropped significantly, leading to lower healthcare costs for patients, demonstrating the economic benefits of Botox therapy in managing NDO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes and resource use of patients with neurogenic detrusor overactivity receiving botulinum toxin A (BOTOX) therapy in Germany. Wefer, B., Ehlken, B., Bremer, J., et al.[2021]

In a Phase IIa study involving 47 adult patients with neurogenic detrusor overactivity, abobotulinumtoxinA (Dysport) significantly reduced the frequency of daily incontinence episodes, with improvements seen in both 15 and 30 injection groups.

Dysport also led to significant enhancements in urodynamic parameters, such as maximum cystometric capacity and detrusor pressure, while the safety profile showed some serious adverse events related to muscle weakness, particularly in patients receiving 15 injections.

NCBI (Pubmed)

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. Denys, P., Del Popolo, G., Amarenco, G., et al.[2022]

In a study involving 836 participants over 12 weeks, both 4 mg and 8 mg doses of fesoterodine significantly improved symptoms of overactive bladder compared to placebo, including reductions in urinary frequency and urgency.

Fesoterodine was well tolerated, with common side effects being dry mouth, constipation, and urinary tract infections, but overall, the treatment showed a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. Nitti, VW., Dmochowski, R., Sand, PK., et al.[2007]

Repeat botulinum toxin A (BTX-A) injections can provide sustained improvements in quality of life for patients with neurogenic detrusor overactivity (NDO), particularly for those receiving four or fewer injections, based on a review of 18 studies involving 1533 patients.

The study found a low rate of adverse events associated with repeat BTX-A injections, indicating that the treatment is generally safe; however, quality of life may decline for patients receiving five or more injections, highlighting the need for further research on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is repeat Botulinum Toxin A injection valuable for neurogenic detrusor overactivity-A systematic review and meta-analysis. Ni, J., Wang, X., Cao, N., et al.[2019]

In a study of 62 spinal cord injury patients who switched from Onabotulinumtoxin A (OTA) to Abobotulinumtoxin A (ATA) for treating neurogenic detrusor overactivity, 28.9% initially responded to ATA injections, with 14.5% maintaining response after a median follow-up of 17 months.

The switch to ATA may provide long-term efficacy for some patients and potentially delay the need for surgical interventions like augmentation enterocystoplasty, as 51.6% of patients were either awaiting or had undergone this surgery during the follow-up period.

NCBI (Pubmed)

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? Le Roy, C., Lefèvre, C., Lepoittevin, L., et al.[2023]

In a study involving 57 children aged 6 to 15 with neurogenic detrusor overactivity, both transdermal and oral oxybutynin significantly improved urine volume, with transdermal oxybutynin showing a mean increase from 95 ml to 125 ml and oral oxybutynin from 114 ml to 166 ml.

Transdermal oxybutynin was found to be well tolerated with fewer side effects compared to oral oxybutynin, indicating it may be a safer alternative for children who have previously used oxybutynin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. Cartwright, PC., Coplen, DE., Kogan, BA., et al.[2013]

Citations

1. urologytimes.com urologytimes.com/view/fda-grants-fast-track-designation-to-eg110a-for-neurogenic-bladder

FDA grants fast track designation to EG110A for ... Overall, interim data from the study showed that at the lowest dose, EG110A was associated with a more than 88% reduction in the incidence of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06596291

NCT06596291 | Dose Escalation Study of EG110A, ... The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments. Masking : None ( ...

3. ics.org ics.org/2024/abstract/33

ICS 2024 Abstract #33 EG110A, a novel non-replicative ... EG110A shows dose-dependent efficacy in a pharmacological model of NDO without impairing voiding function. It is a promising potential new ...

4. eg427.com eg427.com/web/DATA/20251006%20FDA%20Fast%20Track%20vf%20(1).pdf

20251006 FDA Fast Track vf (1).pdf Top-line data showed for the first time in a chronic neuro-urological condition that treatment with our DNA medicine EG110A reduced incontinence ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/milestone-reached-first-patient-treated-with-eg110a-for-neurogenic-bladder/

First Patient Treated with EG110A for Neurogenic Bladder The open-label, dose-escalation study will enroll 16 adults with SCI-related NDO who experience persistent incontinence despite standard care.

6. eg427.com eg427.com/web/DATA/20251001_EG%20427_PR_First%20Cohort%20Data_EN_Vf2.pdf

EG 427 Announces Compelling Initial Topline Clinical ... Over 88% reduction in urinary incontinence episodes achieved in low dose cohort at 12 weeks. • Good tolerability with no systemic side ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06596291

NCT06596291 | Dose Escalation Study of EG110A, ... The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments. Masking : None ( ...

8. withpower.com withpower.com/trial/phase-2-wounds-and-injuries-9-2024-4f782

EG110A for Neurogenic Detrusor Overactivity This Phase 1 & 2 medical study run by EG 427 is evaluating whether EG110A will have tolerable side effects & efficacy for patients with Spinal Cord Injury, ...

9. biospace.com biospace.com/press-releases/eg-427-receives-u-s-fda-fast-track-designation-for-eg110a-dna-medicine-in-neurogenic-bladder-patients

EG 427 Receives U.S. FDA Fast Track Designation for ... Treatment of NDO in people with SCI with the lowest dose of EG110A was found to reduce the incidence of urinary incontinence episodes by over 88 ...