EUCTR2015-002876-25-BEActive, not recruitingPhase 1
An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC) - Crocodile Study
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 91
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject and/or from the subject’s parent(s) or legal guardian(s) prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); assent by the subject is given as required by local law.
- •2. Subject is male or female from 3 to less than 18 years of age.
- •3. Subject has a body weight of = 11 kg.
- •4. Subject suffers from NDO confirmed by urodynamic investigation at baseline. The diagnosis of NDO must be confirmed by the presence of at least 1 involuntary destrusor contraction > 15 cm H2O from baseline destrusor pressure, and/or a decrease in compliance leading to an increase in baseline detrusor pressure of > 20 cm H2O.
- •5. Subject has been using CIC for at least 4 weeks prior to visit 1/screening.
- •6. Subject has a current indication for drug therapy to manage NDO.
- •7. Subject is able to take the study drugs in accordance with the protocol.
- •8. Female subject must either:
- •Be of nonchildbearing potential:
- •- Clearly premenarchal or in the judgment of the investigator is premenarchal,
- •- Documented surgically sterile,
- •or, if of childbearing potential:
- •- Agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
- •- And have a negative pregnancy test at visit 1/screening and at visit 3/baseline,
- •- And, if sexually active must agree to use a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, OR placement of an intrauterine device (IUD) or intrauterine system (IUS). Birth control must be practiced from visit 1/screening and continuing throughout the study period, and for 28 days after the final study drug administration.
- •9. Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from visit 1/screening and continuing throughout the study period, and for 28 days after the final study drug administration.
- •10. Female subject must not be breastfeeding from visit 1/screening until 28 days after last study drug administration.
- •11. Subject and subject’s parent(s)/legal guardian(s) agree that the subject will not participate in another interventional study while participating in the study.
- •12. Subject and subject’s parent(s)/legal guardian(s) are willing and able to comply with the study requirements and with the concomitant medication restrictions.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 63
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Subject has a known genitourinary condition (other than NDO) that may cause overactive
- •contractions or incontinence (e.g., bladder extrophy, urinary tract obstruction, urethral
- •diverticulum or fistula) or kidney/bladder stones or another persistent urinary tract
- •pathology that may cause urinary symptoms.
- •2. Subject has one of following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, subject at risk of gastric retention.
- •3. Subject has a urinary indwelling catheter within 4 weeks prior to visit 1/screening.
- •4. Subject has a surgically treated underactive urethral sphincter.
- •5. Subject has vesico-ureteral reflux grade 3 to 5.
- •6. Subject has undergone bladder augmentation surgery.
- •7. Subject receives electrostimulation therapy, if started within 30 days before visit 1/screening or is expected to start during the study period. Subjects who are on an established regimen may remain on this for the duration of the study.
- •8. Subject suffers from a symptomatic urinary tract infection (UTI) at baseline (symptomatic is defined as pain, fever, hematuria, new onset foul-smelling urine). If present at visit 1/screening or diagnosed between visit 1/screening and visit 3/baseline, the UTI should be treated successfully (clinical recovery) prior to baseline. If a symptomatic UTI is present at baseline, all baseline assessments are allowed to be postponed for a maximum of 7 days until the UTI is successfully treated (clinical recovery).
- •9. Subject has a (mean) resting pulse rate >99th percentile.
- •10. Subject has an established hypertension and systolic or diastolic blood pressure greater than the 99 th percentile of the normal range determined by sex, age, and height, plus mmHg.
- •11. Subject has a risk of QT prolongation (e.g., hypokalemia, long QT syndrome [LQTS]; or family history of LQTS, exercise-induced syncope).
- •12. Subject has severe renal impairment (estimated glomerular filtration rate [eGFR] according to Larsson equation < 30 mL/min).
- •13. Subject’s aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the upper limit of normal (ULN) or total bilirubin greater than or equal to 1.5 times the ULN according to age and sex.
- •14. Subject has a history or presence of any malignancy prior to visit 1/screening.
- •15. Subject has known or suspected hypersensitivity to mirabegron, any of the excipients used in the current formulations or previous severe hypersensitivity to any drug.
- •16. Subject has participated in another clinical trial (and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1/screening.
- •17. Subject uses any of the following prohibited medications (after start of washout):
- •Any medication, other than the study drug, used for the management of NDO;
- •Any drugs that are sensitive cytochrome (CYP) 2D6 substrates with a narrow therapeutic index or sensitive P-glycoprotein (P-gp) substrates
- •Any strong cytochrome P450 (CYP) 3A4 inhibitors if the subject has a mild to moderate renal impairment (eGFR 30 – 89 mL/min).
- •18. Subject has been administered intravesical botulinum toxin; except if given > 4 months prior to visit 1/screening and the subject experiences symptoms comparable to those existing prior to the botulinum toxin injections.
- •19. Subject has any other condition, which in the opinion of the Inves
Investigators
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