Neurogenic Detrusor Overactivity Following Spinal Cord In... | NCT01357980

NCT01357980

ID	Type	Description	Link
2010-023210-31	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Biological	750 U intra detrusor injection on Day 1 (single dose)	Dysport 750 U (15 injection sites) Dysport 750 U (30 injection sites)

Outcomes Module

Measure	Description	Time Frame
Daily Incontinence Episode Frequency (IEF)		Baseline and Day 84

Secondary Outcomes

Measure	Description	Time Frame
Urodynamics: Maximum Cystometric Capacity	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.	Baseline, Days 14, 42 and 84
Urodynamics:Maximum Detrusor Pressure

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ipsen Study Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Faculty Hospital Motol		Prague			Czechia
THOMAYER Faculty Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26756554	Background	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
FG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Demographic characteristics of the Intent to Treat (ITT) population: All randomised subjects who received at least one injection of study treatment and had an assessment for the averaged daily IEF both at Baseline and Day 84.

Arm/Group Information

ID	Title	Description
BG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
BG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
BG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
BG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00014 BG0016 BG00216 BG0036 BG00442

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.1± 12.1 BG00146.5± 10.7 BG00250.5± 11.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0007 BG0012 BG002

Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS)

Number

participants

Title

Denominators

Categories

SCI

Title	Measurements
	BG0009 BG0014 BG002

Number of Subjects Using Anticholinergics

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG0009 BG0015 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Daily Incontinence Episode Frequency (IEF)

Analysis based on number of subjects in the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

episodes per day

Baseline and Day 84

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Units	Counts
Participants	OG00014 OG0016 OG00216 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0004.21± 2.32 OG0013.33± 2.87 OG0023.23± 1.26 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.	ANCOVA		0.11	No multiplicity adjustment applied: each test conducted at a 5% significance level.	Mean Treatment Difference	-1.54			2-Sided	95	-3.47	0.39					Superiority or Other (legacy)

Secondary

Urodynamics: Maximum Cystometric Capacity

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.

Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.

Posted

Mean

Standard Deviation

Baseline, Days 14, 42 and 84

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Urodynamics:Maximum Detrusor Pressure

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.

Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.

Posted

Mean

Standard Deviation

cm water (cm H20)

Baseline, Days 14, 42 and 84

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Physician's Global Assessment Score of Treatment Response

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'.

Analysis based on number of subjects in the Intent to Treat (ITT) population.

Posted

Number

participants

Day 14

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Physician's Global Assessment Score of Treatment Response

Analysis based on number of subjects in the Intent to Treat (ITT) population.

Posted

Number

participants

Day 42

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Physician's Global Assessment Score of Treatment Response

Analysis based on number of subjects in the Intent to Treat (ITT) population.

Posted

Number

participants

Day 84

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Quality of Life (QoL) Total Summary Score

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.

Analysis based on number of subjects in the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 14, 42 and 84

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection

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.

Analysis based on number of subjects in the Safety population with a valid value.

Posted

Mean

Standard Deviation

Baseline

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Secondary

Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure

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.

Analysis based on number of subjects in the Safety population with a valid value.

Posted

Mean

Standard Deviation

Baseline

ID	Title	Description
OG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)
OG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
OG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dysport 750 U (15 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)	5	16	7	16
EG001	Placebo (15 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)	0	7	3	7
EG002	Dysport 750 U (30 Injection Sites)	Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)	1	17	11	17
EG003	Placebo (30 Injection Sites)	Placebo: Intra detrusor injection on day 1 (single dose)	0	7	4	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Depression	Psychiatric disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG0030 events0 affected7 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version: 15.1	Systematic Assessment	EG0003 events3 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute tonsillitis	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG0030 events0 affected7 at risk
Asthenia	General disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0022 events2 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Bacteriuria	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Bladder Pain	Renal and urinary disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected17 at risk EG003
Blood urine present	Investigations	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG003
Fungal infection	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected17 at risk EG003
Hypertension	Vascular disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected17 at risk EG003
Influenza like illness	General disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version: 15.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected17 at risk EG003
Neutrophil count increased	Investigations	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version: 15.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0023 events3 affected17 at risk EG003

ID	Term
D019274	Botulinum Toxins, Type A
C542869	abobotulinumtoxinA

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D045726	Metalloproteases
D001426	Bacterial Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001427	Bacterial Toxins
D014118	Toxins, Biological
D001685	Biological Factors

Units	Counts
Participants	OG00014 OG0016 OG00216 OG0036

Units	Counts
Participants	OG00014 OG0016 OG00216 OG0036

Units	Counts
Participants	OG00014 OG0016 OG00216 OG0036

Units	Counts
Participants	OG00014 OG0016 OG00215 OG0036

Units	Counts
Participants	OG00014 OG0016 OG00214 OG0036