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Dysport® Pediatric Lower Limb Spasticity Follow-on Study

Primary Purpose

Cerebral Palsy, Muscle Spasticity, Children

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 Cerebral Palsy

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects were eligible for participation in the study if they met the following criteria:

Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.
Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.

Exclusion Criteria:

Subjects were excluded from entering the study for the following reasons:

Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle) in the most affected leg to be injected.
Unwillingness or inability to comply with the protocol.
Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.
Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.
Be pregnant and/or lactating.
Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
An infection at the injection site(s).
Planned treatment with any new investigational drug or device during the study period.

Sites / Locations

The Children's Hospital
Rehabilitation Institute of Chicago
Children's Hospital New Orleans
Children's Hospital of Michigan
Gillette Children's Speciality Healthcare
Cincinnati Children's Hospital Medical Center
Shriner's Hospital for Children
Texas Scottish Rite - Hospital for Children
Club De Leones Cruz Del Sur Rehabilitation Corporation Punta Arenas
Dr Roberto Del Rio Hospital
Neurorehabilitation Laboratory, Pontifical Catholic University
CHU Jean Minjoz
Hospital San José Celaya
Centro de Rehabilitacion Infantil
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
B i L- Specjalistyczne Centrum Medyczne
Non-public Healthcare Unit - Grunwaldzka Clinic
Non-public Healthcare Unit Mazovian Neurorehabilitatio
Ghulane Military Medical Academy and School of Medicine
Ibn-i-Sina Hospital
Yildirim Beyazit Training and Research Hospital
GATA Haydarpasa Training Hospital
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
Istanbul University Medical School
Dokuz Eylül University Medical Faculty
Kocaeli University Medical Faculty

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dysport

Arm Description

Dysport was injected into either one or both lower limbs in up to 4 cycles of treatment, a minimum of 12 weeks apart and up to a maximum of 40 weeks apart. Doses varied from 5 Units (U)/Kg to 20 U/kg for one leg, or from 10 U/Kg to 30 U/kg for two legs, with a maximum dose of no more than 30 U/Kg overall, or 1000 U, whichever was reached first.

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.

Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.

Secondary Outcome Measures

Mean Change From Baseline (in the DB Study) in the MAS Score in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Baseline for the 'change from DB baseline' was defined as the baseline of Study 141 for all treatment cycles. The Modified Ashworth Scale (MAS) is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in the MAS Score in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Baseline was defined as the value obtained prior to the first injection in the hamstrings. The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).

Mean Change From Baseline (Prior to the First Injection Cycle in Upper Limb Muscle Groups) in the Mean MAS Score for All Injected Upper Limb Muscle Groups From Treatment Cycle 2 Onwards

Baseline was defined as the value obtained prior to the first injection in the upper limb(s). The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). No subjects were treated in the upper limb in Treatment Cycle 4.

Mean Physician's Global Assessment (PGA) Score

Global assessment of treatment response based on changes since the first injection in the DB study. PGA Scale of the Treatment Response: Global assessment of treatment response was assessed by asking the Investigator the following question: "how would you rate the response to treatment in the subject's lower limb(s) since the first injection in the DB study?" 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).

Mean Goal Attainment Scale (GAS) Score

Individual goals were defined prior to treatment in each treatment period. The GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals were defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. After treatment in each treatment cycle, the GAS for each goal was rated using a defined scale (-2: Much less than expected outcome, -1: Somewhat less than expected outcome, 0: Expected outcome, 1: Somewhat more than expected outcome, and 2: Much more than expected outcome).

Mean Change From DB Baseline in Angle of Arrest (XV1) Derived From the Tardieu Scale (TS), in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb. The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity). The mean change from DB baseline in XV1 at slow speed was derived.

Mean Change From DB Baseline in Angle of Catch (XV3) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Mean Change From DB Baseline in Spasticity Angle (X) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb. The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity). X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from DB baseline was calculated.

Mean Change From DB Baseline in Spasticity Grade (Y) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

The mean change from baseline (in the DB study) in Y was derived from the TS. Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome). Catch without release was graded 0 if XV1=XV3, 'unratable' spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1. Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition.

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV1 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb. The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity). The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV1 at slow speed was derived.

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV3 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in X Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb. The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity). X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from baseline (prior to the first injection cycle in the hamstrings) was calculated.

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in Y Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

The mean change from baseline (prior to the first injection cycle in the hamstrings) in Y was derived from the TS. Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome). Catch without release was graded 0 if XV1=XV3, 'unratable' spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1. Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition.

Mean Change From DB Baseline in the Observational Gait Scale (OGS) Total Score of the (Most) Affected Leg

The OGS is a measurement tool used to objectively quantify positive and negative features (impairments) of the upper motor neurone syndrome. The OGS is useful when children are too young or insufficiently cooperative for instrumented gait analysis. It is based on the Physicians Rating Scale but has some modifications to improve its sensitivity to detect changes following administration of Botulinum Toxin Type A (BTX-A). The OGS total score was calculated as the sum of the individual question scores for Questions 1 to 7, with the highest possible score being 20. The parameters collected were: knee position in midstance, initial foot contact, foot contact at midstance, timing of heel raise, hindfoot at midstance, base of support and gait assistive devices. Higher scores indicate better gait. The mean change from baseline (in the DB study) in the OGS total score of the (most) affected leg was derived.

Mean Change From DB Baseline in the PedsQL Score (CP Module Scores) at Each Study Visit Except Week 4

The PedsQL has a disease specific CP module that is relevant to the study population and complements the core modules. The 35-item questionnaire encompassed 7 scales including (1) daily activities (2) school activities (3) movement and balance (4) pain and hurt (5) fatigue (6) eating activities and (7) speech and communication. A 5-point scale was utilised for parent proxy-report: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Each CP score was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems). A scale score was only calculated if at least 50% of the associated items were non-missing.

Mean Change From DB Baseline in the PedsQL Score (Generic Core Scores) at Each Study Visit Except Week 4

The PedsQL is a validated quality of life questionnaire, designed for children from 2 to 18 years of age. The Generic Core Scale covers four multidimensional scales including physical, emotional, social and school aspects, with three summary scales of total scale score, physical health summary score and psychosocial health summary score. Each generic core scale was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems). A scale score was only calculated if at least 50% of the associated items were non-missing.

Full Information

NCT ID

NCT01251380

First Posted

November 25, 2010

Last Updated

September 15, 2022

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT01251380

Brief Title

Dysport® Pediatric Lower Limb Spasticity Follow-on Study

Official Title

A Phase III, Prospective, Multicentre, Open Label, Extension Study Assessing the Long Term Safety and Efficacy of Repeated Treatment With DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 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 was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

6. Conditions and Keywords

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

Cerebral Palsy, Muscle Spasticity, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dysport

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

AbobotulinumtoxinA (Dysport®)

Intervention Description

Intramuscular (IM) injection on day 1 of each treatment cycle.

Primary Outcome Measure Information:

Title

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.

Description

Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.

Time Frame

From baseline (Day 1) until end of study (Week 40) of Cycle 1 and up to Week 28 of Cycles 2 to 4.

Secondary Outcome Measure Information:

Title

Mean Change From Baseline (in the DB Study) in the MAS Score in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Description

Time Frame

DB baseline; Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in the MAS Score in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Description

Time Frame

Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4.

Title

Mean Change From Baseline (Prior to the First Injection Cycle in Upper Limb Muscle Groups) in the Mean MAS Score for All Injected Upper Limb Muscle Groups From Treatment Cycle 2 Onwards

Description

Time Frame

Baseline and Weeks 4 and 12 of Treatment Cycles 2 and 3.

Title

Mean Physician's Global Assessment (PGA) Score

Description

Time Frame

Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4.

Title

Mean Goal Attainment Scale (GAS) Score

Description

Time Frame

Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From DB Baseline in Angle of Arrest (XV1) Derived From the Tardieu Scale (TS), in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Description

Time Frame

DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From DB Baseline in Angle of Catch (XV3) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Description

Time Frame

DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From DB Baseline in Spasticity Angle (X) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Description

The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb. The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity). X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from DB baseline was calculated.

Time Frame

DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From DB Baseline in Spasticity Grade (Y) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb

Description

Time Frame

DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV1 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Description

Time Frame

Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4

Title

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV3 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Description

Time Frame

Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4

Title

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in X Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Description

The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb. The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity). X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from baseline (prior to the first injection cycle in the hamstrings) was calculated.

Time Frame

Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4

Title

Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in Y Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb

Description

Time Frame

Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4

Title

Mean Change From DB Baseline in the Observational Gait Scale (OGS) Total Score of the (Most) Affected Leg

Description

Time Frame

DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4

Title

Mean Change From DB Baseline in the PedsQL Score (CP Module Scores) at Each Study Visit Except Week 4

Description

Time Frame

Baseline and Week 12

Title

Mean Change From DB Baseline in the PedsQL Score (Generic Core Scores) at Each Study Visit Except Week 4

Description

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects were eligible for participation in the study if they met the following criteria: Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit. Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study. Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable. Exclusion Criteria: Subjects were excluded from entering the study for the following reasons: Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle) in the most affected leg to be injected. Unwillingness or inability to comply with the protocol. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected. Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs. Be pregnant and/or lactating. Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active. An infection at the injection site(s). Planned treatment with any new investigational drug or device during the study period.

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

The Children's Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Rehabilitation Institute of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Children's Hospital New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118

Country

United States

Facility Name

Children's Hospital of Michigan

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Gillette Children's Speciality Healthcare

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Shriner's Hospital for Children

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Texas Scottish Rite - Hospital for Children

City

Dallas

State/Province

Texas

ZIP/Postal Code

75219

Country

United States

Facility Name

Club De Leones Cruz Del Sur Rehabilitation Corporation Punta Arenas

City

Punta Arenas

Country

Chile

Facility Name

Dr Roberto Del Rio Hospital

City

Santiago

Country

Chile

Facility Name

Neurorehabilitation Laboratory, Pontifical Catholic University

City

Santiago

Country

Chile

Facility Name

CHU Jean Minjoz

City

Besancon

Country

France

Facility Name

Hospital San José Celaya

City

Celaya

Country

Mexico

Facility Name

Centro de Rehabilitacion Infantil

City

Mexico City

Country

Mexico

Facility Name

Centro de Rehabilitacion Integral de Queretaro (CRIQ)

City

Queretaro

Country

Mexico

Facility Name

Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU

City

Gdansk

Country

Poland

Facility Name

B i L- Specjalistyczne Centrum Medyczne

City

Lodz

Country

Poland

Facility Name

Non-public Healthcare Unit - Grunwaldzka Clinic

City

Poznan

Country

Poland

Facility Name

Non-public Healthcare Unit Mazovian Neurorehabilitatio

City

Wiazowna

Country

Poland

Facility Name

Ghulane Military Medical Academy and School of Medicine

City

Ankara

Country

Turkey

Facility Name

Ibn-i-Sina Hospital

City

Ankara

Country

Turkey

Facility Name

Yildirim Beyazit Training and Research Hospital

City

Ankara

Country

Turkey

Facility Name

GATA Haydarpasa Training Hospital

City

Istanbul

Country

Turkey

Facility Name

Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi

City

Istanbul

Country

Turkey

Facility Name

Istanbul University Medical School

City

Istanbul

Country

Turkey

Facility Name

Dokuz Eylül University Medical Faculty

City

Izmir

Country

Turkey

Facility Name

Kocaeli University Medical Faculty

City

Izmit

Country

Turkey

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/

Learn more about this trial

Dysport® Pediatric Lower Limb Spasticity Follow-on Study

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