Neurogenic Detrusor OveractivityPhase 1/2NCT03482037
Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury
A Phase 1/2 study testing Rec 0/0438 1 mg or Rec 0/0438 2 mg in people with Neurogenic Detrusor Overactivity, run by RECORDATI GROUP at 9 sites in 4 countries.
Trial summary
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurogenic Detrusor Overactivity
- What is being tested?
- Rec 0/0438 1 mg or Rec 0/0438 2 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 7 Jun 2018to 27 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged ≥18 years and ≤65 years.
- Female subjects must be either sterile or, if with child-bearing potential, must have a pregnancy test negative and commit to the use of a highly effective method of birth control (see Appendix 15.6) for the duration of the study, and until at least 1 month after the last dose of study medication. Male subjects must be willing to use male contraception (condom) to avoid pregnancies of their female partner of childbearing potential throughout the entire duration of the study, and for 3 months after the last dose of study medication.
- Suffering from NDO due to SCI at upper motor neuron level (below C6) and emptying the bladder performing clear intermittent self-catheterization (CISC).
- Subjects classified in group A, B, or C, of the ASIA (American Spinal Injury Association) impairment scale.
- Stable therapy for NDO in the last thirty days (Subjects should maintain the therapy stable for the duration of the study).
- At least 1 incontinence episode/day despite current treatment, according to what is reported in the Bladder Diary filled in by the subject.
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- Subjects with diastolic blood pressure values between 60 and 99 mmHg (both inclusive), and systolic blood pressure values between 90 and 159 mmHg (both inclusive). Blood pressure measurement must be performed in subjects with an empty bladder.
- Subjects with stable concomitant medication treatment at baseline.
- Written informed consent must be given by subjects before any study related investigational procedures is performed.
Who cannot join
- Breastfeeding women.
- Treatment with injection of botulinum toxin, unless in the opinion of the Investigator the bladder activity has returned to pre-treatment level.
- Use of prohibited concomitant medications, such as drugs that could affect immunoassay testing (systemic corticosteroids: prednisone, budesonide, prednisolone; calcineurin inhibitors: cyclosporine, tacrolimus; mTOR inhibitors: sirolimus, everolimus; IMDH inhibitors: azathioprine, leflunomide, mycophenolate; biologics: abatacept, adalimumab, anakinra , certolizumab, etanercept, golimumab, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; monoclonal antibodies: basiliximab, daclizumab, muromonab) or initiation of therapy with drugs affecting lower urinary tract symptoms (such as alpha-blockers, tadalafil 5 mg oad). If already present at Screening visit, therapy with drugs affecting lower urinary tract symptoms must be maintained stable through the study period (Note: occasional treatment with PDE-5 inhibitors for erectile dysfunction should be avoided between Screening visit and Day 8 and between Day 25 and 28).
- History of cerebro- or cardio-vascular diseases (TIA, stroke, hypertensive encephalopathy, angina pectoris, MI, cardiac by-pass, CHF NYHA classes III and IV).
- Uncontrolled type 1 or type 2 diabetes (Hb A1c >8 %).
- Moderate to severe renal impairment (estimated creatinine clearance <60 mL/min by the Cockcroft-Gault equation).
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- Moderate to severe liver impairment (any liver function test: AST, ALT, GGT, Bilirubin >2.5 times the upper limit of normal).
- Hemodynamically significant valve disease, including aortic stenosis or clinically significant ventricular or supraventricular arrhythmia, heart rate >100 beats/min.
- Clinically important abnormal laboratory findings during the run-in period, including: Haemoglobin <10 g/dL; Serum Potassium >5.5 mmol/L; Serum Sodium <132 mmol/L.
- Symptomatic active urinary tract infection (i.e. cloudy and/or malodorous urine, chills, fever, increased muscle spasticity or increased autonomic dysreflexia, letargy, hypotension, malaise).
- Evidence of any neoplastic disease.
- History of allergy, hypersensitivity or intolerance to drugs.
- Participation in an investigational drug study within 30 days prior to the screening assessment.
- Any other diseases or conditions, that according to the Investigator's opinion, make the subject unable to comply with protocol requirements, or unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France4 sites
Department of Urology, Academic hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Sorbonne Universités
Paris, 75013
Centre Hospitalier Lyon Sud Unité de Pharmacie Clinique Oncologique (essai clinique) Pavillon Marcel Bérard - Bât. 1G
Pierre-Bénite, 69495
Recordati Investigative Site
Rouen
Recordati Investigative Site
Toulouse
Poland3 sites
Recordati Investigative Site
Piaseczno
Recordati Investigative Site
Rzeszów
Recordati Investigative Site
Warsaw
About this study
Official title: Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury
Read the detailed description
Multicentre, double-blind, randomised, parallel groups, placebo-controlled study to be conducted in specialized centres in Europe to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of two different doses of Rec 0/0438 in comparison with placebo, in subjects with neurogenic detrusor overactivity due to spinal cord injury.
- Conditions
- Neurogenic Detrusor Overactivity
- Being tested
- Rec 0/0438 1 mg or Rec 0/0438 2 mg, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rec 0/0438 1 mg or Rec 0/0438 2 mgDrug
Each vial content will be administered via the catheter used for the self-catheterization
placeboDrug
Each vial content will be administered via the catheter used for the self-catheterization
| Study group | Role | What they receive |
|---|---|---|
| Rec 0/0438 | Experimental | Rec 0/0438 1 mg (first cohort), 2 mg (second cohort) to be administered by intravesical instillation once daily for four weeks Receives: Drug: Rec 0/0438 1 mg or Rec 0/0438 2 mg |
| Placebo | Placebo comparator | Placebo, to be administered by intravesical instillation once daily for four weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Treatment-emergent adverse events occurred with treatment with Rec 0/0438
Measured: Day 28
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax)
Measured: Day 1 and Day 7
Area Under the Curve (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: Day 1 and Day 7
Change from baseline in Maximum Cystometric Capacity
The volume at which uncontrollable voiding begins during filling Cystometry
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start7 Jun 2018
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
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
- Randomised
- Intervention model
- Sequential
- Model description
- two sequential cohorts, each corresponding to a dose level.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Cruz, M.D., Principal investigator, Hospital São João, Urologia, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482037
- Sponsor's protocol ID
- Rec 0/0438-IT-CL 0491
- Other IDs
- 2017-000905-19, 2017
- Status last verified
- Jan 2021
- First submitted
- 8 Mar 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03482037
- Acronym / sponsor ID
- Rec 0/0438-IT-CL 0491
- Conditions
- Neurogenic Detrusor Overactivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 29 Mar 2018 (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.
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury
Detailed description
Multicentre, double-blind, randomised, parallel groups, placebo-controlled study to be conducted in specialized centres in Europe to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of two different doses of Rec 0/0438 in comparison with placebo, in subjects with neurogenic detrusor overactivity due to spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- two sequential cohorts, each corresponding to a dose level.
| Arm | Type | Receives |
|---|---|---|
| Rec 0/0438 | Experimental | Drug: Rec 0/0438 1 mg or Rec 0/0438 2 mgRec 0/0438 1 mg (first cohort), 2 mg (second cohort) to be administered by intravesical instillation once daily for four weeks |
| Placebo | Placebo comparator | Drug: placeboPlacebo, to be administered by intravesical instillation once daily for four weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects aged ≥18 years and ≤65 years.
- Female subjects must be either sterile or, if with child-bearing potential, must have a pregnancy test negative and commit to the use of a highly effective method of birth control (see Appendix 15.6) for the duration of the study, and until at least 1 month after the last dose of study medication. Male subjects must be willing to use male contraception (condom) to avoid pregnancies of their female partner of childbearing potential throughout the entire duration of the study, and for 3 months after the last dose of study medication.
- Suffering from NDO due to SCI at upper motor neuron level (below C6) and emptying the bladder performing clear intermittent self-catheterization (CISC).
- Subjects classified in group A, B, or C, of the ASIA (American Spinal Injury Association) impairment scale.
- Stable therapy for NDO in the last thirty days (Subjects should maintain the therapy stable for the duration of the study).
Key exclusion criteria (14 listed)
- Breastfeeding women.
- Treatment with injection of botulinum toxin, unless in the opinion of the Investigator the bladder activity has returned to pre-treatment level.
- Use of prohibited concomitant medications, such as drugs that could affect immunoassay testing (systemic corticosteroids: prednisone, budesonide, prednisolone; calcineurin inhibitors: cyclosporine, tacrolimus; mTOR inhibitors: sirolimus, everolimus; IMDH inhibitors: azathioprine, leflunomide, mycophenolate; biologics: abatacept, adalimumab, anakinra , certolizumab, etanercept, golimumab, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; monoclonal antibodies: basiliximab, daclizumab, muromonab) or initiation of therapy with drugs affecting lower urinary tract symptoms (such as alpha-blockers, tadalafil 5 mg oad). If already present at Screening visit, therapy with drugs affecting lower urinary tract symptoms must be maintained stable through the study period (Note: occasional treatment with PDE-5 inhibitors for erectile dysfunction should be avoided between Screening visit and Day 8 and between Day 25 and 28).
- History of cerebro- or cardio-vascular diseases (TIA, stroke, hypertensive encephalopathy, angina pectoris, MI, cardiac by-pass, CHF NYHA classes III and IV).
- Uncontrolled type 1 or type 2 diabetes (Hb A1c >8 %).
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 |
|---|---|---|
| Rec 0/0438 1 mg or Rec 0/0438 2 mgEach vial content will be administered via the catheter used for the self-catheterization | Drug | Rec 0/0438 |
| placeboEach vial content will be administered via the catheter used for the self-catheterization | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Day 28
Treatment-emergent adverse events occurred with treatment with Rec 0/0438
3 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 and Day 7
Area Under the Curve (AUC)
Time frame: Day 1 and Day 7
Change from baseline in Maximum Cystometric Capacity
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Detrusor Overactivity
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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
Neurogenic Detrusor Overactivity, Spinal Cord Injuries
Not yet recruiting
TTNS in SCI Patients With Neurogenic Detrusor Overactivity
Spinal Cord Injuries, Neurogenic Detrusor Overactivity
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The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury
Spinal Cord Injuries (SCI)
Not yet recruitingPhase 1/2
Device for Bladder Control for Men With SCI
Neurogenic Bladder
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. This study is not recruiting at the moment.
Francisco Cruz, M.D. principal investigator
Hospital São João, Urologia, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rec 0/0438 1 mg or Rec 0/0438 2 mg in people with Neurogenic Detrusor Overactivity, run by RECORDATI GROUP at 9 sites in 4 countries.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Poland, Czechia, Portugal. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: Day 28). 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 29 Jan 2021.