Clinical trial NCT01313312: Dysport® Adult Upper Limb Spasticity Extension Study
Official title: A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nervous System Disorders
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: This was a phase III, multicentre, prospective, open label, repeat treatment cycles, extension to the double study Y-52-52120-145 (Study 145) . The study included both rollover subjects from Study 145 and de novo subjects. The primary study objective was to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles. The secondary study objective was to assess the long term efficacy of repeated treatment with Dysport®.

Eligibility criteria: Inclusion Criteria:

* Completion of the double blind study, Y-52-52120-145

Exclusion Criteria:

* Major limitation in the passive range of motion in upper limb

Primary outcomes:
measure: Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose
timeFrame: Up to Week 52
measure: Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR
timeFrame: Up to Week 52
measure: Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies
timeFrame: Up to Week 52
Secondary outcomes:
measure: Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4
timeFrame: At Week 4
measure: Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4
timeFrame: At Week 4
measure: Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4
timeFrame: At Week 4
measure: Mean Change From Baseline MAS in the Wrist Flexors at Week 4
timeFrame: At Week 4
measure: Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4
timeFrame: At Week 4
measure: Mean Change From Baseline MAS in the Elbow Flexors at Week 4
timeFrame: At Week 4
measure: Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4
timeFrame: At Week 4
measure: Mean Change From Baseline MAS in the Shoulder Extensors at Week 4
timeFrame: At Week 4
measure: Physician's Global Assessment (PGA) of Treatment Response at Week 4
timeFrame: At Week 4
measure: Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4
timeFrame: At Week 4
measure: Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4
timeFrame: At Week 4
measure: Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors
timeFrame: At Week 4
measure: Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs
timeFrame: At Week 4
measure: Mean Change From Baseline at Week 4 in Ease of Applying a Splint
timeFrame: At Week 4
measure: Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4
timeFrame: At Week 4
measure: Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit
timeFrame: Up to Week 52
measure: Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Fairfield
country: United States
facility: Associated Neurologist of Southern CT, PT
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease & Movement Disorders Center of Boca Raton
state: Florida
city: South Miami
country: United States
facility: Design Neuroscience Miami
state: Florida
city: Chicago
country: United States
facility: The Rehabilitation Institute of Chicago
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina - Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Southwestern Medical Center at Dallas University of Texas
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas HSC at Ben Hogan Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Bruxelles
country: Belgium
facility: Université catholique de Louvain av Hippocrate 10
city: Yvoir
country: Belgium
facility: Clinique Universitaire
city: Praha 2
country: Czechia
facility: Charles University in Prague
city: Brest
country: France
facility: CHU Brest
city: Coubert
country: France
facility: Centre de Réadaptation de Coubert
city: Créteil
country: France
facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
city: Garches
country: France
facility: Hopital Raymond Poincarré
city: Reims
country: France
facility: Hôpital Sébastopol
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Hopital Rangueil
city: Gyor
country: Hungary
facility: Petz Aladar County Hospital
state: Budapest
city: Budapest
country: Hungary
facility: National Institute for Medical Rehabilitation
city: Catania
country: Italy
facility: Azienda Hospedaliero
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Krakowska Akademia Neurologii
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center
city: Moscow
country: Russian Federation
facility: Scientific Center of Neurology of RAMS
city: St Petersburg
country: Russian Federation
facility: State University
city: Bratislava
country: Slovakia
facility: Derer's Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
citation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.