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Dysport® Adult Lower Limb Spasticity Follow-on Study

Primary Purpose

Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Botulinum toxin type A

About this trial

This is an interventional treatment trial for Post-stroke Spasticity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)

Exclusion Criteria:

Fixed contractures in lower limb

Sites / Locations

Mayo Clinic Arizona
Rancho Los Amigos
Pacific Neuroscience Medical Group
Associated Neurologist of Southern CT, PC
Design Neuroscience Center
Weill Cornell Medical College
Island Neurological Associates
University of North Carolina - Chapel Hill
Wake Forest University Baptist Medical Center
Moss Rehab & Albert Einstein
Vanderbilt University
The University of Texas Southwestern Medical Center at Dalla
University of North Texas HSC at Ben Hogan Center
University of Texas - Houston
University of Utah School of Medicine
St George Hospital
Epworth Rehabilitation
Royal Melbourne Hospital
St Vincent's Hospital
St Vincent's Hospital
Westmead Hospital
Université catholique de Louvain av Hippocrate 10
Clinique Universitaire
Charles University in Prague
CHU Jean MINJOZ
Centre de Réadaptation de Coubert
Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
Hopital Raymond Poincarré
Hôpital de L'Archet I
Hôpital Sébastopol
Hôpital Civil
Hopital Rangueil
National Institute for Medical Rehabilitation
Uno Medical Trials
Petz Aladar Country Hospital
Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"
Specjalistyczna Praktyka Lekarska
Centrum Medyczne Plejady
Krakowska Akademia Neurologii Sp. z o.o.
Malopolskie Centrum Medyczne
Nzoz Neuro - Card
Samodzielny Publiczny Centralny Szpital Kliniczny
Serviço de Reabilitação
Centro Hospitalar Lisboa Norte
Centro Hospitalar São João
Medical Rehabilitation Center
Scientific Research Institute of Neurology
State University
Derer's Hospital
Univerzitna nemocnica Bratislava

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dysport®

Arm Description

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.

Outcomes

Primary Outcome Measures

Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)

Adverse events (AEs) were monitored from the time that the subject gave informed consent to the end of the study/early withdrawal (EOS/EW). An AE was reported as a TEAE if it was not present prior to study treatment administration in Study 140, or if it was present prior to study treatment in Study 140 but the intensity increased during the treatment phase of this study. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any AE that was assessed as a hypersensitivity reaction. TEAEs, treatment related TEAEs, severe TEAEs, TEAEs leading to death, TEAEs leading to withdrawal, treatment emergent AESIs, and serious adverse events (SAEs) are summarised by treatment cycle.

Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)

Systolic and diastolic BP were recorded at baseline and at each subsequent study visit. BP was measured with the subject in a sitting position after resting for 3 minutes. Mean change in BP from baseline at Week 4 is reported per cycle.

Mean Change From Baseline to Week 4 in Heart Rate (HR)

HR was recorded at baseline and at each subsequent study visit. HR was measured with the subject in a sitting position after resting for 3 minutes. Mean change in HR from baseline at Week 4 is reported per cycle.

Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count

Blood samples for RBC count were taken at baseline, at Week 4, and at EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)

Blood samples for haemoglobin and MCHC were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Haematocrit

Blood samples for haematocrit were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)

Blood samples for MCH were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)

Blood samples for MCV were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets

Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

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)

Blood samples were taken at baseline, at Week 4, and at the EOS/EW for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine

Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose

Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at Week 4 and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®

Blood samples were collected at baseline, Week 4 and at EOS/EW to test for the presence of BTX-A antibodies. The number of subjects who were either NAb positive at baseline or negative at baseline but then positive following injection of Dysport® were reported.

Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)

12-lead ECG tracing was performed at baseline, at Week 4 of each cycle and at EOS/EW. The 12-lead ECG recordings were performed at a paper speed of 25 millimetres/second (mm/s), recorded with the subject in a supine position after 5 minutes rest. The ECG parameters; QT Duration, QT interval corrected with Fridericia's method (QTcF), QT interval corrected with Bazett's method (QTcB), QRS duration and PR duration were recorded and outcome measure is reported per cycle as change from baseline at Week 4.

Secondary Outcome Measures

Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)

Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. 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. Outcome measure is reported per cycle as mean change from baseline at Week 4.

Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)

Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. 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 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. Outcome measure is reported per cycle as mean change from baseline at Week 4.

Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4

Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. 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 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. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.

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

Physician's Global Assessment (PGA) of Treatment Response at Week 4

An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. 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 nine-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 scores per cycle at Week 4 were reported.

Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4

An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. 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 nine 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 percentage of responders with a PGA score of +1 or greater are reported at Week 4.

Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended

Range of active dorsiflexion of the ankle joint of the treated limb, measured using a goniometre, both with the knee flexed (90°) and extended, was used to assess treatment response. The measurements were obtained at the end of baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Lower Limb Pain

The intensity of lower limb pain in the treated limb was evaluated by the subject using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: 'no pain' (circle with no red shading and scored as 0) and 'pain as bad as it could be' (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained at baseline, Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW. The mean changes from baseline in subjects with a baseline SPIN Score >0 at Week 4 was reported per cycle.

Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)

Subjects were asked to complete the SF-36 health surveys prior to the study treatment at baseline, at Week 4 and at the EOS/EW visit. The SF-36 is a generic non preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0-100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. The mean change in the PCS and MCS from baseline to Week 4 are reported.

Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL

Subjects were asked to complete the EQ-5D-5L QoL questionnaire prior to the study treatment at baseline, at Week 4 and at EOS/EW visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/ depression and scored their general health state. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems and extreme problems, rated from 1 to 5 (best to worst). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean change in pain and discomfort and VAS scores from baseline to Week 4 are reported.

Mean Change From Baseline to Week 4 in Walking Speed (WS)

All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of WS were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Step Length

All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of step length were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.

Mean Change From Baseline to Week 4 in Cadence

All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of cadence were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.

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)

Spasticity in the treated limb was assessed using the Tardieu Scale (TS) for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.

Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)

Spasticity in the treated limb was assessed using the TS for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.

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)

Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.

Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)

Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.

Use of Walking Aids/Orthoses at Baseline and Week 4

Subjects were assessed on their use of walking aids and orthoses at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW visit. Outcome measure is reported per cycle at baseline and Week 4. Number of subjects with no walking aid/orthoses were included in the 'No Walking Aid' category and number of subjects with any kind of walking aid/orthosis (including single point cane, tripod cane, ankle foot orthosis or other type of walking aid/orthosis) were combined into the 'Walking Aid' category.

Full Information

NCT ID

NCT01251367

First Posted

November 25, 2010

Last Updated

September 15, 2022

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT01251367

Brief Title

Dysport® Adult Lower Limb Spasticity Follow-on Study

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

352 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dysport®

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

AbobotulinumtoxinA (Dysport®)

Intervention Description

I.M. (intramuscular) injection on day 1 of each treatment cycle.

Primary Outcome Measure Information:

Title

Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Up to EOS (maximum duration of 52 weeks).

Title

Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Heart Rate (HR)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count

Description

Blood samples for RBC count were taken at baseline, at Week 4, and at EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)

Description

Blood samples for haemoglobin and MCHC were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Haematocrit

Description

Blood samples for haematocrit were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)

Description

Blood samples for MCH were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)

Description

Blood samples for MCV were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets

Description

Time Frame

Baseline and Week 4 of each cycle

Title

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)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose

Description

Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at Week 4 and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.

Time Frame

Baseline and Week 4 of each cycle

Title

Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®

Description

Time Frame

At Week 4

Title

Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)

Description

Time Frame

Baseline and Week 4 of each cycle

Secondary Outcome Measure Information:

Title

Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4

Description

Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. 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 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. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.

Time Frame

Week 4 of each cycle

Title

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

Description

Time Frame

Week 4 of each cycle

Title

Physician's Global Assessment (PGA) of Treatment Response at Week 4

Description

Time Frame

Week 4 of each cycle

Title

Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4

Description

An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. 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 nine 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 percentage of responders with a PGA score of +1 or greater are reported at Week 4.

Time Frame

Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Lower Limb Pain

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Walking Speed (WS)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Step Length

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Cadence

Description

Time Frame

Baseline and Week 4 of each cycle

Title

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)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

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)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)

Description

Time Frame

Baseline and Week 4 of each cycle

Title

Use of Walking Aids/Orthoses at Baseline and Week 4

Description

Time Frame

Baseline and Week 4 of each cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404) Exclusion Criteria: Fixed contractures in lower limb

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Study Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Rancho Los Amigos

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

Pacific Neuroscience Medical Group

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Associated Neurologist of Southern CT, PC

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Design Neuroscience Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Island Neurological Associates

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

University of North Carolina - Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7200

Country

United States

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Moss Rehab & Albert Einstein

City

Elkins Park

State/Province

Pennsylvania

ZIP/Postal Code

19027

Country

United States

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

The University of Texas Southwestern Medical Center at Dalla

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9016

Country

United States

Facility Name

University of North Texas HSC at Ben Hogan Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

University of Texas - Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Utah School of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

St George Hospital

City

Kogarah

Country

Australia

Facility Name

Epworth Rehabilitation

City

Melbourne

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Melbourne

Country

Australia

Facility Name

St Vincent's Hospital

City

Melbourne

Country

Australia

Facility Name

St Vincent's Hospital

City

Sydney

Country

Australia

Facility Name

Westmead Hospital

City

Sydney

Country

Australia

Facility Name

Université catholique de Louvain av Hippocrate 10

City

Bruxelles

Country

Belgium

Facility Name

Clinique Universitaire

City

Yvoir

Country

Belgium

Facility Name

Charles University in Prague

City

Praha 2

Country

Czechia

Facility Name

CHU Jean MINJOZ

City

Besançon

Country

France

Facility Name

Centre de Réadaptation de Coubert

City

Coubert

Country

France

Facility Name

Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

City

Créteil

Country

France

Facility Name

Hopital Raymond Poincarré

City

Garches

Country

France

Facility Name

Hôpital de L'Archet I

City

Nice

Country

France

Facility Name

Hôpital Sébastopol

City

Reims

Country

France

Facility Name

Hôpital Civil

City

Strasbourg

Country

France

Facility Name

Hopital Rangueil

City

Toulouse

Country

France

Facility Name

National Institute for Medical Rehabilitation

City

Budapest

Country

Hungary

Facility Name

Uno Medical Trials

City

Budapest

Country

Hungary

Facility Name

Petz Aladar Country Hospital

City

Gyor

Country

Hungary

Facility Name

Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"

City

Catania

Country

Italy

Facility Name

Specjalistyczna Praktyka Lekarska

City

Katowice

Country

Poland

Facility Name

Centrum Medyczne Plejady

City

Krakow

Country

Poland

Facility Name

Krakowska Akademia Neurologii Sp. z o.o.

City

Krakow

Country

Poland

Facility Name

Malopolskie Centrum Medyczne

City

Krakow

Country

Poland

Facility Name

Nzoz Neuro - Card

City

Poznan

Country

Poland

Facility Name

Samodzielny Publiczny Centralny Szpital Kliniczny

City

Warszawa

Country

Poland

Facility Name

Serviço de Reabilitação

City

Alcabideche

Country

Portugal

Facility Name

Centro Hospitalar Lisboa Norte

City

Lisbon

Country

Portugal

Facility Name

Centro Hospitalar São João

City

Porto

Country

Portugal

Facility Name

Medical Rehabilitation Center

City

Moscow

Country

Russian Federation

Facility Name

Scientific Research Institute of Neurology

City

Moscow

Country

Russian Federation

Facility Name

State University

City

St Petersburg

Country

Russian Federation

Facility Name

Derer's Hospital

City

Bratislava

Country

Slovakia

Facility Name

Univerzitna nemocnica Bratislava

City

Bratislava

Country

Slovakia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

IPD Sharing URL

https://vivli.org/members/ourmembers/

Citations:

PubMed Identifier

32741133

Citation

Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport(R)) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

Results Reference

derived

PubMed Identifier

32108436

Citation

Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

Results Reference

derived

PubMed Identifier

31529136

Citation

McAllister PJ, Khatkova SE, Faux SG, Picaut P, Raymond R, Gracies JM. Effects on walking of simultaneous upper/lower limb abobotulinumtoxina injections in patients with stroke or brain injury with spastic hemiparesis. J Rehabil Med. 2019 Oct 29;51(10):813-816. doi: 10.2340/16501977-2604.

Results Reference

derived

PubMed Identifier

29093068

Citation

Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

Results Reference

derived

Learn more about this trial

Dysport® Adult Lower Limb Spasticity Follow-on Study

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