Urinary Bladder, OveractivePhase 1/2NCT07227285
Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy
A Phase 1/2 study testing Urodynamics, EG110A and Patient-reported Outcome in people with Urinary Bladder, Overactive and Spinal Cord Injury, run by Cyllene Therapeutics at 4 sites in United States.
Trial summary
The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Bladder, Overactive, Spinal Cord Injury
- What is being tested?
- Urodynamics, EG110A and Patient-reported Outcome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2026to Apr 2031
- 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
Who may be able to join
- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.
Who cannot join
- Participant plans to participate in another investigational gene therapy study
- Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cornelia Haag-Molkenteller, MD contact
United States4 sites
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
John Stoffel, MD
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Evgeniy Kreydin, MD
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas, 77030
Argyrios Stampas, MD
Sidney Kimmel Medical College
Philadelphia, Pennsylvania, 19107
Patrick Shenot, MD
About this study
Official title: Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy Expressing a Transgene Encoding the Light Chain of Botulinum Toxin F
The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.
Read the detailed description
The objective of this long-term follow-up study is to continue following participants who have received EG110A for safety, and to observe long-term efficacy via a disease-specific quality of life questionnaire, time to participant request for alternative treatment, and locally-evaluated urodynamics.
This study aims to identify any potential long-term risks and will capture any delayed adverse events (AEs) in participants following the last study visit of the preceding study. Additionally, it will allow the Sponsor to further understand the long-term effectiveness of EG110A in this patient population.
- Conditions
- Urinary Bladder, Overactive, Spinal Cord Injury
- Being tested
- Urodynamics, EG110A, Patient-reported Outcome
- Medical subject headings
- Urinary Bladder, Overactive, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrodynamicsOther
standardized local evaluation of urodynamic parameters
EG110ADrug
Patients already treated with EG110A
Patient-reported OutcomeOther
assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms
| Study group | Role | What they receive |
|---|---|---|
| Patients who received EG110A in a clinical study, regardless of dose | Experimental | Not described Receives: Other: Urodynamics; Drug: EG110A; Other: Patient-reported Outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent serious adverse events (TESAEs)
Any participant who has a reported treatment emergent serious adverse event (TESAE)
Measured: 5 years
Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)
Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)
Measured: 5 years
Secondary outcomes (2)
Patient-reported outcome (PRO) questionnaire
Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study
Measured: 5 years
Duration of response to EG110A
Time from initial treatment with EG110A to request an alternative treatment for NDO by the participant at any time during the long-term follow-up study
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study startApr 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyllene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cornelia Haag-Molkenteller, MD, Study director, Cyllene Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227285
- Sponsor's protocol ID
- EG110A-001-02
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy Expressing a Transgene Encoding the Light Chain of Botulinum Toxin F
- ClinicalTrials.gov ID
- NCT07227285
- Acronym / sponsor ID
- EG110A-001-02
- Conditions
- Urinary Bladder, Overactive, Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cyllene TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 12 Nov 2025 (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.
The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.
Detailed description
The objective of this long-term follow-up study is to continue following participants who have received EG110A for safety, and to observe long-term efficacy via a disease-specific quality of life questionnaire, time to participant request for alternative treatment, and locally-evaluated urodynamics.
This study aims to identify any potential long-term risks and will capture any delayed adverse events (AEs) in participants following the last study visit of the preceding study. Additionally, it will allow the Sponsor to further understand the long-term effectiveness of EG110A in this patient population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received EG110A in a clinical study, regardless of dose | Experimental | Other: Urodynamics, Drug: EG110A, Other: Patient-reported Outcome |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.
Key exclusion criteria (2 listed)
- Participant plans to participate in another investigational gene therapy study
- Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator
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 |
|---|---|---|
| Urodynamicsstandardized local evaluation of urodynamic parameters | Other | Patients who received EG110A in a clinical study, regardless of dose |
| EG110APatients already treated with EG110A | Drug | Patients who received EG110A in a clinical study, regardless of dose |
| Patient-reported Outcomeassessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms | Other | Patients who received EG110A in a clinical study, regardless of dose |
Primary outcome
Incidence of treatment emergent serious adverse events (TESAEs)
Time frame: 5 years
Any participant who has a reported treatment emergent serious adverse event (TESAE)
Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)
Time frame: 5 years
Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)
2 secondary outcomes
Patient-reported outcome (PRO) questionnaire
Time frame: 5 years
Duration of response to EG110A
Time frame: 5 years
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 12 Nov 2025.
- Individual participant dataSharing planned: No
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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
4 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 Urodynamics, EG110A and Patient-reported Outcome in people with Urinary Bladder, Overactive and Spinal Cord Injury, run by Cyllene Therapeutics at 4 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?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: opening soon, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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)625622802, 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 serious adverse events (TESAEs) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 12 Nov 2025.