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A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity. (DIRECTION)

Primary Purpose

Upper Limb Spasticity

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
AboBoNT-A
OnaBoNT-A
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Limb Spasticity

Eligibility Criteria

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

Inclusion Criteria:

  • Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent
  • 2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study;
  • 2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study
  • Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS;
  • Participants with MAS score of at least 2 at elbow, wrist and finger flexors;
  • Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain);
  • Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii;
  • Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate;
  • Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated, and for at least 1 month prior to study entry in terms of occupational and/or physiotherapy treatment, if treated, and are considered by the investigator likely to remain stable for the duration of the study;

Exclusion Criteria:

  • Major limitations in the passive range of motion in the paretic upper limb;
  • Major neurological impairment (other than limb paresis) that could negatively affect functional performance;
  • Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm listed in Section 5.1, or requiring injection into both arms or any lower limb within the timeframe of the study;
  • Hypersensitivity to any BoNT product or excipients;
  • Hypersensitivity to cow's milk protein (casein);
  • Infection at the proposed injection site(s);
  • Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome);
  • Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety;
  • Women who are pregnant or lactating
  • Participants treated with BoNT of any type for any indication (e.g. bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be treated during the course of the study;
  • Prior history of non-responsiveness to BoNT treatment;
  • Previous surgery, or administration of alcohol or phenol in the study limb 6 months or earlier from study enrolment or planned/likely to be treated during the course of the study;
  • Participants treated with intrathecal baclofen (except if treatment has reached a stable dose for >4 weeks and is likely to remain stable throughout the study), aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) within the 4 weeks prior to study enrolment or planned/likely to be treated during the course of the study
  • Participants who received a COVID-19 vaccine injection within 7 days before the first planned study intervention injection, or planned/likely to be vaccinated within 7 days after the first planned study intervention injection
  • BoNT naïve participants with a history of facial neurogenic disorder (facial paralysis, polyradiculoneuropathy) (only for France).

Sites / Locations

  • University of AlabamaRecruiting
  • HonorHealth Scottsdale Osborn Medical CenterRecruiting
  • Movement Disorders Center of ArizonaRecruiting
  • The University of ArizonaRecruiting
  • Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
  • Parkinson's & Movement Disorders InstituteRecruiting
  • Neuro-Pain Medical CenterRecruiting
  • Loma Linda University Health CareRecruiting
  • Southland Neurologic InstituteRecruiting
  • University of California Los Angeles
  • Hasbani And Hasbani Medical GroupRecruiting
  • Ki Health Partners LLC D/B/A New England Institute for Clinical ResearchRecruiting
  • First Choice NeurologyRecruiting
  • Parkinson's Disease Treatment Center of S.W. Florida
  • Suncoast Neuroscience Associates, IncRecruiting
  • James A Haley Veterans HospitalRecruiting
  • University of South Florida Health-Morsani Center for Advanced HealthcareRecruiting
  • Emory University of School of MedicineRecruiting
  • Hawaii Pacific NeuroscienceRecruiting
  • Shirley Ryan Ability LabRecruiting
  • Fort Wayne Neurological CenterRecruiting
  • McFarland Clinic PC
  • Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland PaRecruiting
  • University of LouisvilleRecruiting
  • LSU Healthcare networkRecruiting
  • University Medical Center New Orleans
  • Culicchia Neurological Clinic
  • UMass Memorial Medical Center - University Campus
  • Quest Research Institute
  • William Beaumont HospitalRecruiting
  • Ascension Genesys Hospital
  • Medical Rehabilitation Group, PC
  • Mary Free Bed Rehabilitation HospitalRecruiting
  • Beaumont Hospital, Grosse Pointe
  • Michigan Center of Medical Research
  • Wayne Neurology PLC
  • Rusk Rehabilitation CenterRecruiting
  • Wr-Crcn, LlcRecruiting
  • Cooper University Health Care
  • Montefiore Medical CenterRecruiting
  • NY Neurology InstituteRecruiting
  • New York UniversityRecruiting
  • Mount Sinai Medical CenterRecruiting
  • Weill Cornell Medicine Clinical and Translational Science CenterRecruiting
  • North Suffolk NeurologyRecruiting
  • Mayo ClinicRecruiting
  • Sunnyview Rehabilitation HospitalRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Cleveland Clinic - Neurological Institute
  • MossRehab - Einstein Medical CenterRecruiting
  • Penn State Health Physical Medicine and Rehabilitation - Neurology
  • Rehabilitation Associates of the Main Line
  • Temple University Hospital
  • University of Pittsburgh Medical Center (UPMC)
  • Albert D. Janerich M.D. and Associates
  • Aether MedicineRecruiting
  • Siskin Hospital for Rehabilitation - NeurologyRecruiting
  • The Vanderbilt ClinicRecruiting
  • University of Texas SouthwesternRecruiting
  • North Texas Institute of Neurology & Headache
  • TIRR Memorial Hermann Research Center
  • UT Health San AntonioRecruiting
  • Texas Institute for Neurological DisordersRecruiting
  • University of Utah School of MedicineRecruiting
  • Carilion Clinic Institute of Orthopaedics and NeurosciencesRecruiting
  • Virginia Tech - Carilion School of Medicine
  • MedStar National Rehabilitation NetworkRecruiting
  • Swedish Neuroscience Institute
  • Medical College of Wisconsin - Froedtert HospitalRecruiting
  • Lawson Health Research InstituteRecruiting
  • Glenrose Rehabilitation Hospital
  • CDHA
  • Moncton HospitalRecruiting
  • Genge PartnersRecruiting
  • McGill University Health Center
  • Royal Columbian Hospital
  • Hotel Dieu Shaver Health And Rehabilitation Centre
  • West Park Healthcare Centre
  • Victoria Medical Rehab ConsultantsRecruiting
  • Centre Les CapucinsRecruiting
  • Hôpital Pellegrin CHU BordeauxRecruiting
  • Hopital Albert Chennevier (CHU Henri Mondor)Recruiting
  • Hopital Sud
  • Hôpital d'Instruction des Armées Laveran
  • Hôpital Saint-Jacques (CHU Nantes)Recruiting
  • Hopital Archet (CHU de Nice)Recruiting
  • Hopital Fernand WidalRecruiting
  • Hôpital Sainte-Marie Paris - Groupe VYVRecruiting
  • Centre Mutualiste de Rééducation et de Réadaptation Fonction
  • Hôpital Jean Bernard (CHU Poitiers)Recruiting
  • Hôpital Pontchaillou (CHU Rennes)Recruiting
  • Pole Saint HelierRecruiting
  • Centre de PerharidyRecruiting
  • Centre Hospitalier de Saint-Amand-les-EauxRecruiting
  • Centre Hospitalier de Saint Amand MontrondRecruiting
  • Hopital Henry Gabrielle (HCL)Recruiting
  • Hopitaux Universitaires De StrasbourgRecruiting
  • Hopital de RangueilRecruiting
  • University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sequence 1

Sequence 2

Arm Description

Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles

Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles

Outcomes

Primary Outcome Measures

Rate of Treatment-emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Rate of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Duration of response
Muscle tone assessed by Modified Ashworth scale (MAS) total score
MAS is a scale which represents improvement in spasticity. This tool assesses muscle tone using a six-point scale from 0 = no change to 4 = considerable increase of affected/rigid region.
Perceived function and pain assessed by the Disability Assessment Scale (DAS) total score
DAS scale to determine the extent of functional impairment in four domains: hygiene, dressing, limb position and pain. Impairment will be assessed on a four-point scale (range 0 to 3, where 0 indicates no disability and 3 indicates severe disability). The four domain ratings will be added to give an overall score between 0 and 12.
Physician global assessment (PGA) of treatment response
PGA answers will be made on a nine-point rating scale (from -4 = markedly worse, to +4 = markedly improved).
Change in Quality of Life (QoL) using the SF-12 perceived health score
12-Item Short-form Health Survey (SF-12) is a health survey that will assess general health and wellbeing. The SF-12 summary score is between 0 and 100, with higher scores indicating better self-reported health.
Change in Quality of Life (QoL) using SQoL-6D
Spasticity-related Quality of Life Tool (SQoL-6D) is a brief questionnaire in six domains (pain/discomfort, involuntary movements or spasms, restricted range of movement, caring for the affected limb, using the affected limb and mobility/balance) using a five-level scale ranging from 0 to 4, with higher scores meaning worse condition.

Full Information

First Posted
June 9, 2021
Last Updated
September 28, 2023
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT04936542
Brief Title
A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
Acronym
DIRECTION
Official Title
A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Other
Arm Description
Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles
Arm Title
Sequence 2
Arm Type
Other
Arm Description
Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles
Intervention Type
Biological
Intervention Name(s)
AboBoNT-A
Other Intervention Name(s)
Dysport®
Intervention Description
AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)
Intervention Type
Biological
Intervention Name(s)
OnaBoNT-A
Other Intervention Name(s)
Botox®
Intervention Description
OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)
Primary Outcome Measure Information:
Title
Rate of Treatment-emergent Adverse Events (TEAEs)
Time Frame
from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks))
Secondary Outcome Measure Information:
Title
Rate of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Time Frame
from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks))
Title
Duration of response
Time Frame
baseline (injection) to retreatment criteria met, from week 10 up to week 24 (for each cycle, 1&2) or baseline to withdrawal or end of study if retreatment criteria not met, up to 24 weeks (for each cycle,1&2, each cycle is a maximum 24 weeks)
Title
Muscle tone assessed by Modified Ashworth scale (MAS) total score
Description
MAS is a scale which represents improvement in spasticity. This tool assesses muscle tone using a six-point scale from 0 = no change to 4 = considerable increase of affected/rigid region.
Time Frame
at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks)
Title
Perceived function and pain assessed by the Disability Assessment Scale (DAS) total score
Description
DAS scale to determine the extent of functional impairment in four domains: hygiene, dressing, limb position and pain. Impairment will be assessed on a four-point scale (range 0 to 3, where 0 indicates no disability and 3 indicates severe disability). The four domain ratings will be added to give an overall score between 0 and 12.
Time Frame
at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks)
Title
Physician global assessment (PGA) of treatment response
Description
PGA answers will be made on a nine-point rating scale (from -4 = markedly worse, to +4 = markedly improved).
Time Frame
at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks)
Title
Change in Quality of Life (QoL) using the SF-12 perceived health score
Description
12-Item Short-form Health Survey (SF-12) is a health survey that will assess general health and wellbeing. The SF-12 summary score is between 0 and 100, with higher scores indicating better self-reported health.
Time Frame
at baseline (injection), 4 weeks, 12 weeks and at end of each cycle (injection cycle 1 and 2; each cycle is a maximum 24 weeks)
Title
Change in Quality of Life (QoL) using SQoL-6D
Description
Spasticity-related Quality of Life Tool (SQoL-6D) is a brief questionnaire in six domains (pain/discomfort, involuntary movements or spasms, restricted range of movement, caring for the affected limb, using the affected limb and mobility/balance) using a five-level scale ranging from 0 to 4, with higher scores meaning worse condition.
Time Frame
at baseline (injection), 4 weeks, 12 weeks and at end of each cycle (injection cycle 1 and 2; each cycle is a maximum 24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent 2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study; 2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS; Participants with MAS score of at least 2 at two muscle groups (one of these two muscles groups should be the PTMG) and at least 1 in the remaining muscle group. Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain); Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii; Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate; Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated are considered by the investigator likely to remain stable for the duration of the study; Exclusion Criteria: Major limitations in the passive range of motion in the paretic upper limb; Major neurological impairment (other than limb paresis) that could negatively affect functional performance; Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm listed in Section 5.1, or requiring injection into both arms or any lower limb within the timeframe of the study; Hypersensitivity to any BoNT product or excipients; Hypersensitivity to cow's milk protein (casein); Infection at the proposed injection site(s); Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome); Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety; Women who are pregnant or lactating Participants treated with BoNT of any type for any indication (e.g. bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be treated during the course of the study; Prior history of non-responsiveness to BoNT treatment; Previous surgery, or administration of alcohol or phenol in the study limb 6 months or earlier from study enrolment or planned/likely to be treated during the course of the study; Participants treated with intrathecal baclofen (except if treatment has reached a stable dose for >4 weeks and is likely to remain stable throughout the study), aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) within the 4 weeks prior to study enrolment or planned/likely to be treated during the course of the study BoNT naïve participants with a history of facial neurogenic disorder (facial paralysis, polyradiculoneuropathy) (only for France). Participants receiving concomitant medication treatment with the following PT/OT interventions on the study limb: new splinting/orthotics/casting, serial casting, shockwave therapy, dry needling and needle tenotomies. However, PT/OT interventions not intended to reduce study limb spasticity (e.g. functional training exercises) or with a transient (<1 day) reduction of study limb spasticity (e.g. stretching, weight bearing) are allowed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ipsen Recruitment Enquiries
Phone
see email
Email
clinical.trials@ipsen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
25233
Country
United States
Individual Site Status
Recruiting
Facility Name
HonorHealth Scottsdale Osborn Medical Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Name
Movement Disorders Center of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Parkinson's & Movement Disorders Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Name
Loma Linda University Health Care
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Name
Southland Neurologic Institute
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hasbani And Hasbani Medical Group
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Name
Ki Health Partners LLC D/B/A New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
First Choice Neurology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkinson's Disease Treatment Center of S.W. Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Individual Site Status
Withdrawn
Facility Name
Suncoast Neuroscience Associates, Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Recruiting
Facility Name
James A Haley Veterans Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida Health-Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University of School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Name
Shirley Ryan Ability Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3167
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Name
McFarland Clinic PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
500101
Country
United States
Individual Site Status
Withdrawn
Facility Name
Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1358
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
LSU Healthcare network
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Culicchia Neurological Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Withdrawn
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Individual Site Status
Withdrawn
Facility Name
William Beaumont Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Genesys Hospital
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Withdrawn
Facility Name
Medical Rehabilitation Group, PC
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mary Free Bed Rehabilitation Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Beaumont Hospital, Grosse Pointe
City
Grosse Pointe
State/Province
Michigan
ZIP/Postal Code
48230
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Michigan Center of Medical Research
City
Grosse Pointe
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wayne Neurology PLC
City
Plymouth
State/Province
Michigan
ZIP/Postal Code
48170
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rusk Rehabilitation Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203-3248
Country
United States
Individual Site Status
Recruiting
Facility Name
Wr-Crcn, Llc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Cooper University Health Care
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
NY Neurology Institute
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medicine Clinical and Translational Science Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
North Suffolk Neurology
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunnyview Rehabilitation Hospital
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic - Neurological Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MossRehab - Einstein Medical Center
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Health Physical Medicine and Rehabilitation - Neurology
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rehabilitation Associates of the Main Line
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Individual Site Status
Withdrawn
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Albert D. Janerich M.D. and Associates
City
Plains
State/Province
Pennsylvania
ZIP/Postal Code
18705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Aether Medicine
City
Wayne
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Individual Site Status
Recruiting
Facility Name
Siskin Hospital for Rehabilitation - Neurology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Name
The Vanderbilt Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Institute of Neurology & Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Withdrawn
Facility Name
TIRR Memorial Hermann Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Institute for Neurological Disorders
City
Sherman
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Carilion Clinic Institute of Orthopaedics and Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Tech - Carilion School of Medicine
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MedStar National Rehabilitation Network
City
Columbia
State/Province
Washington
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical College of Wisconsin - Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Glenrose Rehabilitation Hospital
City
Edmonton
ZIP/Postal Code
T5G 0B7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
CDHA
City
Halifax
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Moncton Hospital
City
Moncton
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Genge Partners
City
Montréal
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Center
City
Montréal
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Royal Columbian Hospital
City
New Westminster
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Hotel Dieu Shaver Health And Rehabilitation Centre
City
Saint Catharines
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
West Park Healthcare Centre
City
Toronto
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Victoria Medical Rehab Consultants
City
Victoria
ZIP/Postal Code
V9A 3P2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Les Capucins
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Pellegrin CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Albert Chennevier (CHU Henri Mondor)
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Sud
City
Echirolles
ZIP/Postal Code
38434
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital d'Instruction des Armées Laveran
City
Marseille
ZIP/Postal Code
13384
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Saint-Jacques (CHU Nantes)
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Archet (CHU de Nice)
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Fernand Widal
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Sainte-Marie Paris - Groupe VYV
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Mutualiste de Rééducation et de Réadaptation Fonction
City
Ploemeur
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Jean Bernard (CHU Poitiers)
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Pontchaillou (CHU Rennes)
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Pole Saint Helier
City
Rennes
ZIP/Postal Code
35043
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Perharidy
City
Roscoff
ZIP/Postal Code
29680
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Saint-Amand-les-Eaux
City
Saint-Amand-les-Eaux
ZIP/Postal Code
59230
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Saint Amand Montrond
City
Saint-Amand-Montrond
ZIP/Postal Code
18200
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henry Gabrielle (HCL)
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Name
Hopitaux Universitaires De Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
University of Puerto Rico
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Individual Site Status
Not yet recruiting

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
34562231
Citation
Esquenazi A, Ayyoub Z, Verduzco-Gutierrez M, Maisonobe P, Otto J, Patel AT. AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. Adv Ther. 2021 Nov;38(11):5623-5633. doi: 10.1007/s12325-021-01896-3. Epub 2021 Sep 25.
Results Reference
derived

Learn more about this trial

A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.

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