Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT01357980
• Recruitment Status: Completed
• First Posted: May 23, 2011
• Results First Posted: September 1, 2014
• Last Update Posted: September 27, 2022
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Tracking Information

• First Submitted Date: May 17, 2011
• First Posted Date: May 23, 2011
• Results First Submitted Date: March 27, 2014
• Results First Posted Date: September 1, 2014
• Last Update Posted Date: September 27, 2022
• Study Start Date: May 2011
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 21, 2014): Daily Incontinence Episode Frequency (IEF) [ Time Frame: Baseline and Day 84 ]
• Original Primary Outcome Measures (submitted: May 20, 2011): Mean change from baseline in daily incontinence episode frequency [ Time Frame: Day 84 ]

Current Secondary Outcome Measures (submitted: August 21, 2014)

• Urodynamics: Maximum Cystometric Capacity [ Time Frame: Baseline, Days 14, 42 and 84 ]
  Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.
• Urodynamics:Maximum Detrusor Pressure [ Time Frame: Baseline, Days 14, 42 and 84 ]
  Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.
• Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 14 ]
  The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
• Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 42 ]
  The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
• Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 84 ]
  The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
• Quality of Life (QoL) Total Summary Score [ Time Frame: Baseline, 14, 42 and 84 ]
  Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score. The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0="Not at all" to 4="Extremely" for the first 6 items, from 0="Never" to 4="Always" for item 7 and from 0="Always" to 4="Never" for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated. Total score has been calculated as the mean of all the items completed among the 8 items. Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL.
• Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection [ Time Frame: Baseline ]
  Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
• Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure [ Time Frame: Baseline ]
  Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.

Original Secondary Outcome Measures (submitted: May 20, 2011)

• Urodynamic examination [ Time Frame: Screening visit, day 14, 42 and 84 ]
• Physician's Global Assessment score of treatment response [ Time Frame: Day 14, 42 and 84 ]
• Quality of life total summary score [ Time Frame: Day 1, 14, 42 and 84 ]
• Pain visual analogue scale (VAS) score [ Time Frame: Day 1 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
• Official Title: A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.
• Brief Summary: The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Detrusor Muscle Hyperactivity

Intervention

• Biological: Botulinum toxin type A
  750 U intra detrusor injection on Day 1 (single dose)
  Other Name: AbobotulinumtoxinA (Dysport®)
• Drug: Placebo
  Intra detrusor injection on Day 1 (single dose)

Study Arms

• Experimental: Dysport 750 U (15 injection sites)
  Intervention: Biological: Botulinum toxin type A
• Placebo Comparator: Placebo (15 injection sites)
  Intervention: Drug: Placebo
• Experimental: Dysport 750 U (30 injection sites)
  Intervention: Biological: Botulinum toxin type A
• Placebo Comparator: Placebo (30 injection sites)
  Intervention: Drug: Placebo

• Publications *: Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2013): 47
• Original Estimated Enrollment (submitted: May 20, 2011): 56
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
• Inadequate response or refractory to anticholinergic medication
• Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
• Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit

Exclusion Criteria:

• Significant Baseline renal and/or urinary tract pathology
• Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia, France, Germany, Italy, Poland
• Removed Location Countries: Austria, Czech Republic

Administrative Information

• NCT Number: NCT01357980
• Other Study ID Numbers: Y-52-52120-155; 2010-023210-31 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
• URL: https://vivli.org/members/ourmembers/

• Current Responsible Party: Ipsen
• Original Responsible Party: Ipsen Study Director, Ipsen
• Current Study Sponsor: Ipsen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ipsen Study Director; Ipsen

• PRS Account: Ipsen
• Verification Date: September 2022