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.
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
- Conditions the study is for
- Neurogenic Detrusor Overactivity, Spinal Cord Injuries
- 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:
- 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.
- Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
- Participant has:
- 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
- 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:
- Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
- 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).
- 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.
Cornelia Haag-Molkenteller, MD contact
5 sites in 1 country
United States5 sites, 4 recruiting
- Withdrawn
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
- Recruiting
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
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 group | Role | What they receive |
|---|---|---|
| EG110A (low dose) | Experimental | Patients who Received EG110A (low dose) Receives: Drug: EG110A |
| EG110A (Middle Dose) | Experimental | Patients who Received EG110A (middle dose) Receives: Drug: EG110A |
| EG110A (Low-low Dose) | Experimental | Patients 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.
Incidence of treatment-emergent adverse events (TEAEs)
Any participant who has a reported treatment-emergent adverse events (TEAEs)
Measured: 1 year
Secondary outcomes (2)
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
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.
- First posted19 Sep 2024
- Study start8 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Detrusor OveractivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cyllene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Cornelia Haag-Molkenteller, MD, Study director, Cyllene Therapeutics
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06596291
- Acronym / sponsor ID
- EG110A-001-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cyllene TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| EG110A (low dose) | Experimental | Drug: EG110APatients who Received EG110A (low dose) |
| EG110A (Middle Dose) | Experimental | Drug: EG110APatients who Received EG110A (middle dose) |
| EG110A (Low-low Dose) | Experimental | Drug: EG110APatients who Received EG110A (low-low dose) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EG110AParticipants treated with EG110A | Drug | EG110A (Low-low Dose), EG110A (Middle Dose), EG110A (low dose) |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 1 year
Any participant who has a reported treatment-emergent adverse events (TEAEs)
2 secondary outcomes
Urodynamic variables: changes at Weeks 12 and 52 compared to baseline
Time frame: 1 year
Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Learn more about the clinical study EG110A-001-01Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Detrusor Overactivity
Not yet recruiting
TTNS in SCI Patients With Neurogenic Detrusor Overactivity
Spinal Cord Injuries, Neurogenic Detrusor Overactivity
RecruitingPhase 2/3
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
Neurogenic Detrusor Overactivity
Recruiting
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Spinal Cord Injuries, Neuromodulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cornelia Haag-Molkenteller, MD contact
Cornelia Haag-Molkenteller, MD study director
Cyllene Therapeutics
5 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.