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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02660359




Registration number
NCT02660359
Ethics application status
Date submitted
14/01/2016
Date registered
21/01/2016

Titles & IDs
Public title
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
Scientific title
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
Secondary ID [1] 0 0
2015-000507-44
Secondary ID [2] 0 0
D-FR-52120-223
Universal Trial Number (UTN)
Trial acronym
CONTENT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence 0 0
Overactive Bladder 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Botulinum toxin type A
Treatment: Other - Botulinum toxin type A
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: 600 U Dysport® Group -

Placebo comparator: 600 U Dysport® Placebo Group -

Experimental: 800 U Dysport® Group -

Placebo comparator: 800 U Dysport® Placebo Group -


Treatment: Other: Botulinum toxin type A
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.

Treatment: Other: Botulinum toxin type A
800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

Treatment: Drugs: Placebo
AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

Treatment: Drugs: Placebo
AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
Timepoint [1] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [1] 0 0
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
Timepoint [1] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [2] 0 0
Percentage of Subjects With a UI Response at Improvement Levels =30%, =50%, and =75% at Week 6 of the DBPC Cycle
Timepoint [2] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [3] 0 0
Median Time Between Treatments
Timepoint [3] 0 0
Day of first treatment (baseline) to day of retreatment, up to 2 years
Secondary outcome [4] 0 0
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle
Timepoint [4] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [5] 0 0
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
Timepoint [5] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [6] 0 0
Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle
Timepoint [6] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [7] 0 0
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle
Timepoint [7] 0 0
Baseline and Week 6 of DBPC Cycle
Secondary outcome [8] 0 0
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle
Timepoint [8] 0 0
Baseline and Week 6 of DBPC Cycle

Eligibility
Key inclusion criteria
Key

* Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
* Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
* Subjects with Multiple Sclerosis 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 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.
* Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
* An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.

Key
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any current condition (other than NDO) that may impact on bladder function.
* Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
* Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
* 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 (e.g. detrusor or urethral sphincter treatments).
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2019
Sample size
Target
Accrual to date
Final
258
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince of Wales Hospital (POWH) - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Godoy Cruz
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerp
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Esneux
Country [7] 0 0
Brazil
State/province [7] 0 0
Campinas
Country [8] 0 0
Brazil
State/province [8] 0 0
Curitiba
Country [9] 0 0
Brazil
State/province [9] 0 0
Passo Fundo
Country [10] 0 0
Brazil
State/province [10] 0 0
Porto Alegre
Country [11] 0 0
Brazil
State/province [11] 0 0
Pôrto Alegre
Country [12] 0 0
Brazil
State/province [12] 0 0
Ribeirao Preto
Country [13] 0 0
Brazil
State/province [13] 0 0
Santo André
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Brazil
State/province [15] 0 0
São Paulo
Country [16] 0 0
Chile
State/province [16] 0 0
Santiago
Country [17] 0 0
Colombia
State/province [17] 0 0
Bogotá
Country [18] 0 0
Colombia
State/province [18] 0 0
Cali
Country [19] 0 0
Colombia
State/province [19] 0 0
Manizales
Country [20] 0 0
Colombia
State/province [20] 0 0
Medellin
Country [21] 0 0
France
State/province [21] 0 0
Garches
Country [22] 0 0
France
State/province [22] 0 0
Lille Cedex
Country [23] 0 0
France
State/province [23] 0 0
Marseille CEDEX 5
Country [24] 0 0
France
State/province [24] 0 0
Nimes Cedex 9
Country [25] 0 0
France
State/province [25] 0 0
Orleans
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 20
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pierre-Bénite
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Rouen Cedex
Country [31] 0 0
France
State/province [31] 0 0
Toulouse Cedex 9
Country [32] 0 0
Germany
State/province [32] 0 0
Bonn
Country [33] 0 0
Germany
State/province [33] 0 0
Monchengladbach
Country [34] 0 0
Germany
State/province [34] 0 0
Münster
Country [35] 0 0
Israel
State/province [35] 0 0
Haifa
Country [36] 0 0
Israel
State/province [36] 0 0
Kfar Saba
Country [37] 0 0
Israel
State/province [37] 0 0
Petah Tikva
Country [38] 0 0
Israel
State/province [38] 0 0
Ramat Gan
Country [39] 0 0
Lithuania
State/province [39] 0 0
Kaunas
Country [40] 0 0
Lithuania
State/province [40] 0 0
Vilnius
Country [41] 0 0
Mexico
State/province [41] 0 0
Colima
Country [42] 0 0
Mexico
State/province [42] 0 0
Cuauhtémoc
Country [43] 0 0
Mexico
State/province [43] 0 0
Monterrey
Country [44] 0 0
Mexico
State/province [44] 0 0
Zapopan
Country [45] 0 0
Peru
State/province [45] 0 0
Lima
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Penza
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Rostov-on-Don
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint Petersburg
Country [50] 0 0
Spain
State/province [50] 0 0
A Coruña
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Sevilla
Country [54] 0 0
Spain
State/province [54] 0 0
Valencia
Country [55] 0 0
Ukraine
State/province [55] 0 0
Kharkiv
Country [56] 0 0
Ukraine
State/province [56] 0 0
Kiev
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Aberdeen
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Bedford
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Sheffield
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Stanmore
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Wakefield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02660359