EUCTR2015-003471-30-IT进行中（未招募）1 期
A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 226
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The following inclusion criteria will be assessed at the beginning of the Screening process:
- •1) Written informed consent prior to any study-related procedure.
- •2) Male or female, aged 18 to 80 years inclusive.
- •3) UI for at least 3 months prior to Screening as a result of NDO due to SCI or MS.
- •4) Subjects with SCI must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
- •Subjects with MS must be clinically stable in the investigator’s opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
- •5) Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
- •6) Subjects who are to continue on concomitant oral medications for NDO during the study must be on a stable dose for at least 4 weeks prior to Screening.
- •7) Subjects who are to continue on concomitant oral medications for NDO during the study must be willing to continue on the same medications and doses during Screening and for at least 12 weeks following the first IMP administration.
- •8) Routinely performing CIC to ensure adequate bladder emptying (regularly performing CIC at a regimen of every 4–6 hours during waking hours, or more frequently). CIC regimen must be stable for at least 4 weeks prior to Screening (CIC may be performed by the subject or caregiver).
- •9) Subjects must be willing to continue on the same CIC regimen during Screening and for at least 12 weeks following the first IMP administration.
- •10) Female subjects of childbearing potential must have a negative pregnancy test result and be willing to use reliable contraceptive measures throughout study participation.
- •Reliable forms of contraception include but are not limited to:
- •hormonal contraceptives (e.g. oral, patch, injection)
- •double barrier (e.g. male condom plus spermicide, or female diaphragm plus spermicide)
- •intrauterine device
- •male partner has had a vasectomy
- •total abstinence from intercourse with male partners (periodic abstinence is not acceptable).
- •Female subjects meeting any of the following criteria are not considered to be of childbearing potential:
- •postmenopausal (=47 years of age and amenorrhoeic for at least 12 consecutive months)
- •have been sterilised surgically (e.g. bilateral tubal ligation)
- •have had a hysterectomy
- •have had a bilateral oophorectomy.
- •11) Documented urinary tract ultrasound is available in the 6 months prior to Screening, confirming that no medical issues exist that would preclude entry to the study (e.g. bladder stones or unexplained renal mass).
- •If not performed in the 6 months prior to Screening or results are not available, then a urinary tract ultrasound must be conducted during Screening.
- •12) Ability to complete all study requirements in the opinion of the investigator, including regularly completing the 7-day bladder diary and attending all scheduled study visits. The caregiver may assist with the completion of study documentation and procedures (including the bladder diary and questionnaires), if required.
- •The following inclusion criteria will be assessed following completion of screening bladder diary:
- •13) An average of at least two episodes per day of UI recorded on the screening bladder diary.
- •14) No more than two incontinent-free days documented on the screening bladder diary.
排除标准
- •The following exclusion criteria will be assessed throughout the Screening process:
- •1) Any current condition (other than NDO) that may impact on bladder function, including but not limited to:
- •predominant stress UI (rather than NDO-related incontinence)
- •bladder stones
- •current symptomatic urinary tract infection
- •current active genitourinary infection, e.g. genital warts
- •uterine prolapse
- •cystocele
- •rectocele.
- •Mild uterine prolapse, cystocele or rectocele that does not impact on bladder function is not exclusionary.
- •2) Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
- •3) Surgery less than 6 months prior to Screening for bladder stones.
- •4) Surgery less than 6 months prior to Screening for uterine prolapse, cystocele or rectocele.
- •5) Previous open surgery for NDO, e.g. augmentation cystoplasty.
- •6) Previous urethral stent placement or sphincterotomy.
- •7) Previous or current diagnosis of, or symptoms/signs/investigations suggestive of, significant urological or pelvic disease, including but not limited to:
- •urinary tract malignancy (e.g. bladder, prostate, urethral or kidney cancer)
- •hydronephrosis
- •interstitial cystitis/bladder pain syndrome
- •müllerian duct cysts
- •radiation cystitis
- •genitourinary tuberculosis.
- •8) Previous or current uninvestigated haematuria. Subjects with investigated haematuria may enter the study if significant urological/renal pathology has been ruled out to the satisfaction of the investigator.
- •9) Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
- •10) Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
- •11) BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
- •12) BTX-A treatment within 3 months prior to Screening for any non-urological condition.
- •13) Bladder instillation with any pharmacologic agent less than 3 months prior to Screening.
- •14) Use of capsaicin or resiniferatoxin less than 6 months prior to Screening.
- •15) Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening and must remain off throughout study participation.
- •16) Any concomitant therapy usage that, in the investigator’s opinion, would interfere with the evaluation of safety or efficacy of the IMP, and/or confound the study results.
- •17) History of chronic drug or alcohol abuse.
- •18) Female subject who is pregnant or planning to become pregnant during the study, or is currently lactating (breastfeeding).
- •19) Any medical condition or disease that might interfere with neuromuscular function, e.g. diagnosed myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis.
- •20) Use of medications that affect neuromuscular transmission, such as curare-like depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics.
- •21) Previous primary or secondary non response to any botulinum toxins for the targeted condition.
- •22) Known hypersensitivity to BTX-A or to any components in the IMP formulation (including cow’s milk protein).
- •23) History of allergy to, or intolerance to, the anaesthetic or antibiotic ag
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