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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01249404




Registration number
NCT01249404
Ethics application status
Date submitted
25/11/2010
Date registered
29/11/2010

Titles & IDs
Public title
Dysport® Adult Lower Limb Spasticity Study
Scientific title
A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
Secondary ID [1] 0 0
2009-015868-34
Secondary ID [2] 0 0
Y-55-52120-140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leg Spasticity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

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

Experimental: Dysport® 1000 U, IM - 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)

Experimental: Dysport® 1500 U, IM - 1500 U, I.M., on day 1 (single treatment cycle)

Placebo comparator: Placebo - I.M., on day 1 (single treatment cycle)


Treatment: Other: Botulinum toxin type A
I.M. injection on day 1 (single treatment cycle)

Treatment: Drugs: Placebo
I.M. injection on day 1 (single treatment cycle)
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
Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
Assessment method [1] 0 0
Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.
Timepoint [1] 0 0
Baseline and Week 4
Secondary outcome [1] 0 0
Physician's Global Assesment (PGA) of Treatment Response at Week 4
Assessment method [1] 0 0
An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.
Timepoint [1] 0 0
At Week 4
Secondary outcome [2] 0 0
Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed
Assessment method [2] 0 0
Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.
Timepoint [2] 0 0
Baseline and Week 4

Eligibility
Key inclusion criteria
* Subjects aged 18 to 80 years of age
* Post stroke or brain injury
* Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
* Ambulatory patients
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Fixed contractures
* Physiotherapy initiated less than 4 weeks before entry
* Previous surgery or previous treatment with phenol and/or alcohol in lower limb
* Neurological/neuromuscular disorders which may interfere with protocol evaluations

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 assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
388
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth HealthCare - Richmond
Recruitment hospital [2] 0 0
Caulfield Hospital - Caulfield
Recruitment hospital [3] 0 0
Saint Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Saint Vincent's Hospital - Fitzroy
Recruitment hospital [5] 0 0
St George Hospital - Kogarah
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [7] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [8] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
- Kogarah
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Richmond
Recruitment postcode(s) [8] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Yvoir
Country [13] 0 0
Czechia
State/province [13] 0 0
Olomouc
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha
Country [15] 0 0
France
State/province [15] 0 0
Besançon
Country [16] 0 0
France
State/province [16] 0 0
Brest
Country [17] 0 0
France
State/province [17] 0 0
Coubert
Country [18] 0 0
France
State/province [18] 0 0
Créteil
Country [19] 0 0
France
State/province [19] 0 0
Garches
Country [20] 0 0
France
State/province [20] 0 0
Nice
Country [21] 0 0
France
State/province [21] 0 0
Reims
Country [22] 0 0
France
State/province [22] 0 0
Strasbourg
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Gyor
Country [26] 0 0
Hungary
State/province [26] 0 0
Kisbér
Country [27] 0 0
Italy
State/province [27] 0 0
Catania
Country [28] 0 0
Italy
State/province [28] 0 0
Fossano
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Treviso
Country [31] 0 0
Poland
State/province [31] 0 0
Katowice
Country [32] 0 0
Poland
State/province [32] 0 0
Krakow
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Poland
State/province [34] 0 0
Warsaw
Country [35] 0 0
Portugal
State/province [35] 0 0
Alcabideche
Country [36] 0 0
Portugal
State/province [36] 0 0
Lisbon
Country [37] 0 0
Portugal
State/province [37] 0 0
Porto
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Saint Petersburg
Country [40] 0 0
Russian Federation
State/province [40] 0 0
St Petersburg
Country [41] 0 0
Slovakia
State/province [41] 0 0
Bratislava

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

Ethics approval
Ethics application status

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

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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01249404