ISPEN D-FR-52120-222

Study StatusEnrolling
ProtocolD-FR-52120-222
SponsorIpsen Innovation
Study Description

A Phase 3, multicenter, randomized, 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.

Primary Endpoint

To assess the efficacy of two Dysport doses (600 U and 800 U), compared to placebo in reducing UI from Baseline to Week 6 following the first investigational medicinal product (IMP) administration.

Inclusion Criteria

-Subject must be a male or female age 18 to 80 years inclusive.
-UI for at least 3 months prior to screening as a result of NDO due to SCI or MS.
-Subjects with SCI must have stable neurological injury at T1 level or below which occurred at least 6 months prior to screening.
-OR-
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
-Subjects must have an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO and/or have intolerable side-effects.
-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.
-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.
-Routinely performing CIC to ensure adequate bladder emptying (every 4-6 hours or more frequently). CIC regimen must be stable for at least 4 weeks prior to Screening.
-Subjects must be willing to continue on the same CIC regimen during Screening and for at least 12 weeks following the first IMP administration.
-Female subjects of childbearing potential must have a negative pregnancy test and be willing to use reliable contraceptive measures throughout study participation. (hormonal contraceptives, double barrier, intrauterine device, male partner has had a vasectomy, total abstinence from intercourse with male partners).
Female subjects are considered NOT to be of childbearing potential if any of the following are met: postmenopausal (≥47 years of age and amenorrheoic for at least 12 months, have been sterilized surgically, have had a hysterectomy, have had bilateral oophorectomy.
-Documented urinary tract ultrasound available in the 6 months prior to Screening, confirming that no medical issues exist that would preclude entry to the study.
*--The following criteria will be assessed following completion of screening bladder diary:

  • An average of at least two episodes/day of UI recorded on the screening bladder diary
  • No more than two incontinent-free days documented on the screening bladder diary.
  • Following completion of the screening urodynamic assessment NDO will be assessed (defined as presence of IDCs during the storage phase of urodynamic filling cystometry) 

 

Exclusion Criteria

-Any current condition (other than NDO) that may impact on bladder function (predominant stress UI, bladder stones, current symptomatic UTI, current active genitourinary infection, uterine prolapse, cystocele, rectocele). Note: mild uterine prolapse, cystocele or rectocele that does not impact on bladder function is not exclusionary.
-Previous or current, tumor or malignancy affecting the spinal column or spinal cord or any other nonstable cause of SCI
-Surgery less than 6 months prior to Screening for bladder stones, uterine prolapse, cystocele or rectocele
-Previous open surgery for NDO, e.g. augmentation cystoplasty
-Previous urethral stent placement or sphincterotomy.
-Previous or current diagnosis of or symptoms/signs/investigations suggestive of significant urological or pelvic disease, including but not limited to: urinary tract malignancy, hydronephrosis, interstitial cystitis/bladder pain syndrome, mullerian duct cysts, radiation cystitis, genitourinary tuberculosis.
-Any condition preventing cystoscopic treatment administration or CIC usage
-Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
-BTX-A treatment within 9 months prior to Screening for any urological condition
-BTX-A treatment within 3 months prior to Screening for any non-urological condition
-Bladder instillation with any pharmacologic agent less than 3 months prior to Screening
-Use of capsaicin or resiniferatoxin less than 6 months prior to Screening
-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 remain off throughout study participation.
-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.
-History of chronic drug or alcohol abuse
-Female subject who is pregnant, planning to become pregnant during the study, or is currently lactating (breastfeeding)
-Any medical condition or disease that might interfere with neuromuscular function
-Use of medications that affect neuromuscular transmission, such as curare-like depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics.
-Previous primary or secondary non-response to any botulinum toxins for the targeted condition
-Known hypersensitivity to BTX-A or to any components in the IMP formulation (including cow’s milk protein)
-History or allergy or intolerance to the anaesthetic or antibiotic agents that the investigator intends to use during the study.
-Unable to stop medications with anticoagulant/antiplatelet effects for at least 3 days prior to each IMP administration and to recommence the day following each IMP administration.
-Any condition that may cause excessive bleeding
*--The following criteria will be assessed following completion of screening bladder diary and when screening blood results become available:

  • Voided urine volume ≥3 L during a single 24 hour period on screening bladder diary
  • Serum creatinine ≥2 times the upper limit of normal on screening serum chemistry testing.
Side Effects

Interested in enrolling in this trial? Please call 717-431-2285.


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