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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01251367




Registration number
NCT01251367
Ethics application status
Date submitted
25/11/2010
Date registered
1/12/2010

Titles & IDs
Public title
Dysport® Adult Lower Limb Spasticity Follow-on Study
Scientific title
A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury
Secondary ID [1] 0 0
2009-017723-26
Secondary ID [2] 0 0
Y-55-52120-142
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-stroke Spasticity 0 0
Spasticity Post-Traumatic Brain Injury 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

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

Experimental: Dysport® - Dysport® is injected into lower limbs across 4 cycles of treatment, a minimum of 12 weeks between 2 injections. Doses vary from 1000 U to 1500 U.


Treatment: Other: Botulinum toxin type A
I.M. (intramuscular) injection on day 1 of each treatment cycle.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to EOS (maximum duration of 52 weeks).
Primary outcome [2] 0 0
Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)
Timepoint [2] 0 0
Baseline and Week 4 of each cycle
Primary outcome [3] 0 0
Mean Change From Baseline to Week 4 in Heart Rate (HR)
Timepoint [3] 0 0
Baseline and Week 4 of each cycle
Primary outcome [4] 0 0
Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count
Timepoint [4] 0 0
Baseline and Week 4 of each cycle
Primary outcome [5] 0 0
Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)
Timepoint [5] 0 0
Baseline and Week 4 of each cycle
Primary outcome [6] 0 0
Mean Change From Baseline to Week 4 in Haematocrit
Timepoint [6] 0 0
Baseline and Week 4 of each cycle
Primary outcome [7] 0 0
Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)
Timepoint [7] 0 0
Baseline and Week 4 of each cycle
Primary outcome [8] 0 0
Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)
Timepoint [8] 0 0
Baseline and Week 4 of each cycle
Primary outcome [9] 0 0
Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets
Timepoint [9] 0 0
Baseline and Week 4 of each cycle
Primary outcome [10] 0 0
Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)
Timepoint [10] 0 0
Baseline and Week 4 of each cycle
Primary outcome [11] 0 0
Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine
Timepoint [11] 0 0
Baseline and Week 4 of each cycle
Primary outcome [12] 0 0
Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose
Timepoint [12] 0 0
Baseline and Week 4 of each cycle
Primary outcome [13] 0 0
Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®
Timepoint [13] 0 0
At Week 4
Primary outcome [14] 0 0
Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)
Timepoint [14] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [1] 0 0
Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
Timepoint [1] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [2] 0 0
Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)
Timepoint [2] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [3] 0 0
Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4
Timepoint [3] 0 0
Week 4 of each cycle
Secondary outcome [4] 0 0
Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4
Timepoint [4] 0 0
Week 4 of each cycle
Secondary outcome [5] 0 0
Physician's Global Assessment (PGA) of Treatment Response at Week 4
Timepoint [5] 0 0
Week 4 of each cycle
Secondary outcome [6] 0 0
Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4
Timepoint [6] 0 0
Week 4 of each cycle
Secondary outcome [7] 0 0
Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended
Timepoint [7] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [8] 0 0
Mean Change From Baseline to Week 4 in Lower Limb Pain
Timepoint [8] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [9] 0 0
Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)
Timepoint [9] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [10] 0 0
Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL
Timepoint [10] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [11] 0 0
Mean Change From Baseline to Week 4 in Walking Speed (WS)
Timepoint [11] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [12] 0 0
Mean Change From Baseline to Week 4 in Step Length
Timepoint [12] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [13] 0 0
Mean Change From Baseline to Week 4 in Cadence
Timepoint [13] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [14] 0 0
Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended)
Timepoint [14] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [15] 0 0
Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)
Timepoint [15] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [16] 0 0
Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed)
Timepoint [16] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [17] 0 0
Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)
Timepoint [17] 0 0
Baseline and Week 4 of each cycle
Secondary outcome [18] 0 0
Use of Walking Aids/Orthoses at Baseline and Week 4
Timepoint [18] 0 0
Baseline and Week 4 of each cycle

Eligibility
Key inclusion criteria
* Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Fixed contractures in lower limb

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
352
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Epworth Rehabilitation - Melbourne
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [4] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [5] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [6] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
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
Praha 2
Country [14] 0 0
France
State/province [14] 0 0
Besançon
Country [15] 0 0
France
State/province [15] 0 0
Coubert
Country [16] 0 0
France
State/province [16] 0 0
Créteil
Country [17] 0 0
France
State/province [17] 0 0
Garches
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
France
State/province [19] 0 0
Reims
Country [20] 0 0
France
State/province [20] 0 0
Strasbourg
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Hungary
State/province [22] 0 0
Budapest
Country [23] 0 0
Hungary
State/province [23] 0 0
Gyor
Country [24] 0 0
Italy
State/province [24] 0 0
Catania
Country [25] 0 0
Poland
State/province [25] 0 0
Katowice
Country [26] 0 0
Poland
State/province [26] 0 0
Krakow
Country [27] 0 0
Poland
State/province [27] 0 0
Poznan
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Portugal
State/province [29] 0 0
Alcabideche
Country [30] 0 0
Portugal
State/province [30] 0 0
Lisbon
Country [31] 0 0
Portugal
State/province [31] 0 0
Porto
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moscow
Country [33] 0 0
Russian Federation
State/province [33] 0 0
St Petersburg
Country [34] 0 0
Slovakia
State/province [34] 0 0
Bratislava

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 Study 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?

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/NCT01251367