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A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261167
Recruitment Status : Completed
First Posted : August 24, 2017
Results First Posted : October 18, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400 units of botulinum toxin A which can help to increase the maximum dose per administration to 400 units from 240 units as the treatment with 240 units is considered insufficient in subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase followed by open-label phase in which 400 units of the study treatment will be injected in both the groups. The study period will be up to 52 weeks, consisting of a screening phase up to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).

Condition or disease Intervention/treatment Phase
Spasticity, Post-Stroke Drug: Botulinum toxin A (GSK1358820) Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will receive either 400 units of botulinum toxin A injection or 240 units of botulinum toxin A injection plus placebo in double blind phase. Eligible subjects for open-label treatment period will receive 400 units of botulinum toxin A injection.
Masking: Double (Participant, Investigator)
Masking Description: This study will contain a double blind treatment period (Part 1) followed by open-label treatment period (Part 2/Part3/Part4).
Primary Purpose: Treatment
Official Title: A Phase III Study (a Placebo Controlled, Randomized, Double-blind Comparative Study and an Open-label, Uncontrolled Study) to Evaluate the Efficacy and Safety of GSK1358820 in Patients With Post-stroke Upper Limb Spasticity
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Part 1: Subjects receiving 400 units of botulinum toxin A
Subjects will receive a total dose of 400 units of botulinum toxin A of which 240 units will be injected into the muscles that act on finger (including thumb flexors) and wrist flexors, and a total of 160 units will be injected into the muscles that act on the elbow flexors.
Drug: Botulinum toxin A (GSK1358820)
GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.

Active Comparator: Part 1: Subjects receiving 240 units of botulinum toxin A
Subjects will receive 240 units of botulinum toxin A injected into the muscles that act on the finger (including thumb flexors) and wrist flexors. Placebo will be injected into the muscles that act on the elbow flexors.
Drug: Botulinum toxin A (GSK1358820)
GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.

Drug: Placebo
Placebo injection will contain sodium chloride (0.9 mg).

Experimental: Part 2,3,4: Subjects receiving 400 units of botulinum toxin A
Subjects will receive botulinum toxin A with a dose of 400 units injected in a divided doses.
Drug: Botulinum toxin A (GSK1358820)
GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.




Primary Outcome Measures :
  1. Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6 [ Time Frame: Week 6 ]
    MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 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) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.


Secondary Outcome Measures :
  1. Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 [ Time Frame: Week 2, Week 4, Week 6 and Week 12 ]
    MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 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) when the affected part(s) is moved in flexion or extension, 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 through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.

  2. Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12 ]
    The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 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) when the affected part(s) is moved in flexion/extension, 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 through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

  3. Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12 [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12 ]
    The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

  4. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment [ Time Frame: Up to 84 days post first treatment ]
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.

  5. Number of Participants With AEs and SAEs-Overall Study Period [ Time Frame: Up to Week 48 ]
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.

  6. Number of Participants With Abnormal Findings After Physical Examinations [ Time Frame: Up to Week 48 ]
    Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.

  7. Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline [ Time Frame: Up to Week 48 ]
    Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.

  8. Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline [ Time Frame: Up to Week 48 ]
    Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.

  9. Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis [ Time Frame: Up to Week 48 ]
    Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.

  10. Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48 [ Time Frame: Baseline (Day 1), Week 12 and Week 48 ]
    Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.

  11. Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48 [ Time Frame: Baseline (Day 1), Week 12 and Week 48 ]
    Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.

  12. Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48 [ Time Frame: Baseline (Day 1), Week 12 and Week 48 ]
    Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For screening phase (Day -28 to Day -1): Between 20 and 80 years of age at the time of informed consent (ICF).
  • Subjects with at least a 3-month history of upper limb spasticity after the most recent stroke.
  • Subjects who have spastic symptoms in the finger (including the thumb), wrist, and elbow flexors whom the investigator considers the injections of 400 units of the product is necessary for the upper limb based on the muscle spasms and the symptoms of the subject.
  • Subjects who have a previous treatment history of 240 units of the product for the upper limb at least 16 weeks before screening.
  • Subjects who meet following criteria on MAS at screening (Test position : sitting): at least 3 in for the elbow flexors and at least 2 in the finger or wrist flexors.
  • Subjects who have severe upper limb spasticity, which deserves to be treated with 400 units of the product in the divided dose and was previously injected 240 units of the product.
  • Subjects whom the investigator considers that enrolment in the study poses no problems based on the laboratory data results at screening.
  • Subjects who are free from a history of acute decreased lung function (hospitalization with aggravated asthma/ chronic obstructive pulmonary disease (COPD), pneumonia, or signs of pneumonia, or abnormal reactive airway diseases suggested on X-rays) within the last 3 months at screening and have stable pulmonary function (oxygen saturation [SpO2]value is >=95%).
  • Body weight >=40 kilograms (kg) at screening.
  • Male or female subjects will be included. Male subjects must content to use highly effective contraceptive methods and sperm donation must be avoided. Female subjects who are not pregnant or lactating are considered eligible if at least one of the following criteria is met; non-childbearing potential, women of childbearing potential who content to follow the guidance about contraception during the study period and at least for 3 months after the last dose of the product, no plan of pregnancy during the study period.
  • Subjects who have ability to sign their name on the ICF.
  • For enrolment in the study (Day 1 [prior to injection]):Subjects who meet the following criteria on MAS score: (Test position : sitting): At least 3 in the elbow flexors and at least 2 in the finger or wrist flexors.
  • If centrally acting muscle relaxants, tetracycline antibiotics, anticholinergics, benzodiazepines, or benzamides are given, the dose and regimen must be stable at least for the last 2 months before Day 1; Subjects who can maintain the same dosage and regimens at least in the blind phase after initial injection (dose reductions and discontinuation of the drugs are acceptable in the open-label phase. However, second dose increase, resumption, and or new treatment will not be performed).
  • If intrathecal baclofen is given, the dose and regimen must be stable at least for the last 1 month before Day 1; Subjects who can maintain the same dosage and regimens at least in the blind phase after initial injection (intravenous bolus is not acceptable, dose reductions and discontinuation of the drugs are acceptable. However, second dose increase, resumption, and or new treatment will not be performed).
  • If antiepileptic agents are given, the dose and regimen must be stable at least for the 1 month before Day 1; Subjects who can maintain the same dose and regimens at least in the blind phase after initial injection (dose reductions and discontinuation of the drugs are acceptable in the open-label phase. However, second dose increase, resumption, and new treatment will not be performed).
  • If a physical therapy, occupational therapy, or a static splint on the study involvement upper limbs is given, the frequency and treatment regimen must be stable at least for the last 3 weeks before Day 1; Subjects who can maintain the same dose and regimens at least in blind phase (In the open-label phase, the frequency and treatment regimen can be changed depending on the condition of spasticity).

Exclusion Criteria:

  • For screening phase (Day -28 to Day -1): Subjects present with spasticity requiring treatment in the non-paralytic side of the upper limb.
  • Subjects who have fixed contracture in the finger (upper limb), wrist, elbow or shoulder muscle, which will be involved in the study.
  • Subjects who have medically significant capsulitis or subluxation in any one of the fingers (upper limb), wrist, elbow and shoulder, which will be involved in the study, or whom a investigator considers the complicated local signs of pain may affect the efficacy evaluation.
  • Subjects's upper limb spasticity is attributed to other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, or cerebral palsy).
  • Subjects who have a 2-fold higher alanine aminotransferase (ALT) level than the upper limit of normal (ULN).
  • Subjects who have a 1.5-fold higher bilirubin than the ULN (If a bilirubin fractionation shows direct bilirubin < 35%, a 1.5-fold higher free bilirubin than the ULN is acceptable).
  • Subjects whom the investigator considers presence of a current medical history of unstable liver diseases or biliary tract diseases (the condition will be defined by development of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or hepatic cirrhosis).
  • Subjects with corrected QT interval (QTc) > 450 milliseconds (msec) or QTc > 480 msec in subjects with bundle branch block.
  • Subjects who use peripherally acting muscle relaxants (dantrolene sodium, suxamethonium chloride, pancuronium bromide, vecuronium bromide, rocuronium bromide, etc.) within 1 week of screening.
  • Subjects who use antibiotic agents with neuromuscular junction inhibitory effects: Aminoglycoside antibiotic agents (streptomycin sulfate, kanamycin sulfate, gentamicin sulfate, neomycin sulfate, spectinomycin hydrochloride, etc.), polypeptides (polymyxin B sulfate), lincomycins (lincomycin hydrochloride, clindamycin), and enviomycin sulfate within 1 week of screening.
  • Subjects who was diagnosed as having a malignant tumor, or have a history of a malignant tumor within the last 5 years (except completely resected basal cell carcinoma or planocellular carcinoma at least 12 weeks before screening).
  • Subjects who have participated in another study of an investigational product or other medical research (a clinical study of pharmacotherapy, non-pharmacotherapy, or interventional device) within 30 days before screening, or are currently participating in a study.
  • Subjects who are concerned likely to have an increased risk for an underlying medical condition/neurological disease due to exposure of the product; subjects who have myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or a serious disease and use of a concomitant drug which may inhibit neuromuscular function.
  • Subjects with antihuman immunodeficiency virus (HIV) antibody positive.
  • Subjects who previously experienced allergic reactions or hypersensitivity due to botulinum toxin type A, an additive agent of sodium chloride, or human serum albumin.
  • Subjects who were previously suspected to have neutralizing antibody production by a investigator during an injection of botulinum toxin type A.
  • Subjects who have a skin disease such as infection at the site to be injected.
  • Subjects who suffer from serious and unstable disease, which could pose problems for the safety of subjects and study procedure compliance.
  • For enrolment in the study (Day 1 [prior to injection]): Subjects who have aspiration pneumonia, relapse of lower respiratory tract infection, uncontrollable asthma, uncontrollable COPD, and/or underlying or a history of serious respiratory dysfunction, which were clinically considered to be respiratory function impairment by a investigator within 12 months before Day 1 visit.
  • Subjects who have a history of aspiration, or an underlying and/or a history of the symptoms that suggests high risks for aspiration by a investigator within 12 months before Day 1 (serious salivation requiring changing in a type of diet, chronic dysphagia that is difficult to swallow).
  • Subjects who were treated with botulinum toxin for spasticity of upper limb less than 16 weeks before Day 1 visit.
  • Subjects who underwent surgical interventions, phenol block, ethanol block or muscle afferent block (MAB) within 12 months before Day 1 visit, or these interventions are planned during the study period in any one of the finger (upper limb), wrist, elbow or shoulder muscles, which will be involved in the study.
  • Subjects who placed a surgical cast or a dynamic splint within 3 months before Day 1 study visit, and/or these interventions are planned to be placed on the upper limb to be involved in the study.
  • Subjects who were injected corticosteroid or an anesthetic agent into the finger (upper limb), wrist, or shoulder flexors, which will be involved in the study within 3 months before Day 1 visit, or these injections are planned during the study.
  • Subjects who received constraint-induced movement therapy (CIMT) within 3 months before Day 1 visit or CIMT is planned during the blind phase.
  • Subjects who underwent ultrasound therapy, transcutaneous electrical nerve stimulation (TENS) , electrical stimulation therapy, or acupuncture therapy in the upper arm, which will be involved in the study within 1 month before Day 1 visit, or these therapies are planned during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261167


Locations
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Japan
GSK Investigational Site
Aichi, Japan, 465-8620
GSK Investigational Site
Aichi, Japan, 490-1405
GSK Investigational Site
Chiba, Japan, 277-8567
GSK Investigational Site
Chiba, Japan, 279-0021
GSK Investigational Site
Fukui, Japan, 910-0067
GSK Investigational Site
Fukuoka, Japan, 819-8551
GSK Investigational Site
Hiroshima, Japan, 720-0825
GSK Investigational Site
Hiroshima, Japan, 734-8530
GSK Investigational Site
Hokkaido, Japan, 005-0802
GSK Investigational Site
Hyogo, Japan, 651-2181
GSK Investigational Site
Ibaraki, Japan, 300-0028
GSK Investigational Site
Ibaraki, Japan, 312-0057
GSK Investigational Site
Kagoshima, Japan, 890-0067
GSK Investigational Site
Kanagawa, Japan, 227-8518
GSK Investigational Site
Kanagawa, Japan, 232-0024
GSK Investigational Site
Kanagawa, Japan, 245-8560
GSK Investigational Site
Kanagawa, Japan, 259-1143
GSK Investigational Site
Kochi, Japan, 780-0051
GSK Investigational Site
Kumamoto, Japan, 862-0924
GSK Investigational Site
Nagano, Japan, 399-6461
GSK Investigational Site
Niigata, Japan, 945-8585
GSK Investigational Site
Oita, Japan, 870-0862
GSK Investigational Site
Okayama, Japan, 703-8265
GSK Investigational Site
Osaka, Japan, 538-0044
GSK Investigational Site
Osaka, Japan, 570-8507
GSK Investigational Site
Osaka, Japan, 580-0032
GSK Investigational Site
Saga, Japan, 849-8501
GSK Investigational Site
Shizuoka, Japan, 417-0801
GSK Investigational Site
Shizuoka, Japan, 433-8511
GSK Investigational Site
Tokushima, Japan, 770-8503
GSK Investigational Site
Tokyo, Japan, 102-8798
GSK Investigational Site
Tokyo, Japan, 105-8471
GSK Investigational Site
Tokyo, Japan, 123-0853
GSK Investigational Site
Tokyo, Japan, 165-8906
GSK Investigational Site
Tokyo, Japan, 192-0032
GSK Investigational Site
Tokyo, Japan, 201-8601
GSK Investigational Site
Wakayama, Japan, 641-8509
GSK Investigational Site
Yamagata, Japan, 992-0057
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] April 4, 2017
Statistical Analysis Plan  [PDF] April 2, 2018


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03261167     History of Changes
Other Study ID Numbers: 207660
First Posted: August 24, 2017    Key Record Dates
Results First Posted: October 18, 2019
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Botulinum toxin A
Safety
post-stroke upper limb spasticity
Efficacy
GSK1358820
double blind
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents