Joint Clinical Trials Office

You are here

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 UI in MS or SCI

Clinical Trial Details

This study evaluates the efficacy and safety of 2 Dysport dosages (600 and 800 units), compared with matching placebo, injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity (NDO) due to either spinal cord injury (SCI) or multiple sclerosis (MS) in subjects who have not been adequately managed with anticholinergic therapy and who use Clean Intermittent Catheterization (CIC) as voiding mode. 

Key Eligibility: 

- Written informed consent prior to any study related procedure. 
- Male or female, aged 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 a 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 investigators 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 (e.g. anticholinergics, beta-3 agonists) 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 (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). 
- 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 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. 
- 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. 
- 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: 
- An average of at least two episodes per day of UI recorded on the screening bladder diary. 
- No more than two incontinent-free days documented on the screening bladder diary. 

The following inclusion criterion will be assessed following completion of screening urodynamic assessment: 

- NDO (defined as the presence of IDCs during the storage phase of urodynamic filling cystometry). 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Dominique Dana Marie Thomas
(646) 962-9395
dot2007@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1512016814

Status

Open to Enrollment

Age Group

Adult

Sponsor