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Neurogenic Detrusor OveractivityPhase 1/2NCT06596291

Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

A Phase 1/2 study testing EG110A in people with Neurogenic Detrusor Overactivity and Spinal Cord Injuries, run by Cyllene Therapeutics at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
EG110A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
5 sitesUnited States
Study dates
8 Jan 2025to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening but no more than 12 years post injury.
  2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
  3. Participant has:
  4. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention. OR
  5. had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.

Main Exclusion Criteria:

  1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
  2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).
  3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities/AEs attributable to previously administered cancer therapies that have not resolved or stabilized.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sandrine Zourbas, Ph.D. contact

33 (0)6 25 62 28 02

szourbas@eg427.com

Cornelia Haag-Molkenteller, MD contact

Cornelia@eg427.com

5 sites in 1 country

United States5 sites, 4 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Withdrawn

  • Ohio State University

    Columbus, Ohio, 43212

    Iryna Crescenze, MD, 614-293-8155, Iryna.Crescenze@osumc.edu

    Recruiting

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

    Evgeniy Kreydin, MD

    Recruiting

  • UTHealth Houston / TIRR Memorial Hermann

    Houston, Texas, 77030

    Argyrios Stampas, MD

    Recruiting

  • Sidney Kimmel Medical College

    Philadelphia, Pennsylvania, 19107

    Patrick Shenot, MD

    Recruiting

Other trials in United States

About this study

Official title: First-In-Human Phase 1b/2a Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adult Participants With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

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.

Read the detailed description

This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.

Being tested
EG110A
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EG110ADrug

    Participants treated with EG110A

Study groups in NCT06596291
Study groupRoleWhat they receive
EG110A (low dose)ExperimentalPatients who Received EG110A (low dose)
Receives: Drug: EG110A
EG110A (Middle Dose)ExperimentalPatients who Received EG110A (middle dose)
Receives: Drug: EG110A
EG110A (Low-low Dose)ExperimentalPatients who Received EG110A (low-low dose)
Receives: Drug: EG110A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Any participant who has a reported treatment-emergent adverse events (TEAEs)

    Measured: 1 year

Secondary outcomes (2)

  1. Urodynamic variables: changes at Weeks 12 and 52 compared to baseline

    Changes in urodynamic variables will be assessed at Weeks 12 and 52.

    Measured: 1 year

  2. Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline

    7 day bladder diary with recording of urinary incontinence episodes, daily catheterization rates, and volume per catheterization.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start8 Jan 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This first-in-human clinical study, performed in SCI participants with UI due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06596291
Sponsor's protocol ID
EG110A-001-01
Other IDs
HT94252510505_CDMRP
Status last verified
Sep 2026
First submitted
11 Sep 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EG110A in people with Neurogenic Detrusor Overactivity and Spinal Cord Injuries, run by Cyllene Therapeutics at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandrine Zourbas, Ph.D. (33 (0)6 25 62 28 02, szourbas@eg427.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06596291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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