Last updated: 11/04/2018 05:47:24
Study of GSK1358820 In Patients With Post-Stroke Lower Limb SpasticityN/A
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multicenter Study to Evaluate the Efficacy and Safety in Patients with Post-Stroke Lower Limb Spasticity Receiving a Double-Blind, Placebo-Controlled GSK1358820 Treatment Followed by an Open-Label GSK1358820 Treatment
Trial description: This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Area under the curve (AUC) for the change from Baseline in Modified Ashworth Scale (MAS) ankle score to the end of the DB phase (Week 12)
Timeframe: Baseline, Week 12
Secondary outcomes:
Mean change from Baseline in the MAS Ankle Score from baseline to week 12 of the double-blind phase
Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12
Mean change from baseline in the Physician's Rating Score (PRS) from baseline to week 12 of the double-blind phase
Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12
Mean change from baseline in the time (seconds) to walk 10 meters from baseline to week 12 of the double-blind phase
Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12
Mean change from Baseline in the Clinical Global Impression (CGI) Score of functional disability assessed by the Investigator from baseline to week 12 of the double-blind phase
Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12
Mean change from Baseline in the Clinical Global Impression (CGI) Score of functional disability assessed by the participant from baseline to week 12 of the double-blind phase
Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12
Mean change from Baseline in the Clinical Global Impression (CGI) Score of functional disability assessed by the physiotherapist/occupational therapist from baseline to week 12 of the double-blind phase
Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12
Mean change from Baseline (at the start of the double-blind phase) in the MAS Ankle Score at 4, 8, and 12 weeks after each injection in the open-label phase
Timeframe: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Mean change from Baseline (at the start of the double-blind phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 weeks after each injection in the open-label phase
Timeframe: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Mean change from Baseline (at the start of the double-blind phase) in the time (seconds) to walk 10 meters at 4, 8, and 12 weeks after each injection in the open-label phase
Timeframe: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Mean change from Baseline (at the start of the double-blind phase) in the Clinical Global Impression (CGI) Score of functional disability assessed by the Investigator at 4, 8, and 12 weeks after each injection in the open-label phase
Timeframe: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Mean change from Baseline (at the start of the double-blind phase) in the Clinical Global Impression (CGI) Score of functional disability assessed by the participant at 4, 8, and 12 weeks after each injection in the open-label phase
Timeframe: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Mean change from Baseline (at the start of the DB phase) in the Clinical Global Impression (CGI) Score of functional disability assessed by the physiotherapist/occupational therapist at 4, 8, and 12 weeks after each injection in the open-label phase
Timeframe: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Interventions:
Enrollment:
120
Primary completion date:
2008-24-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Post-Stroke Spasticity, Cerebrovascular Accident
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
May 2007 to December 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20 - 80 years
Accepts healthy volunteers
No
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- Patients with lower limb spasticity who are at least 6 months post-stroke and present with equinus deformity (plantar flexion of the ankle) at the start of double-blind phase (Visit 2).
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Bilateral hemiplegia or quadriplegia.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- Patients with lower limb spasticity who are at least 6 months post-stroke and present with equinus deformity (plantar flexion of the ankle) at the start of double-blind phase (Visit 2).
- Patients with MAS ankle score of ≥3 at the start of double-blind phase (Visit 2).
- Male or female between 20 and 80 years of age at the time of informed consent. For males, only those who can practice contraception during the study period are eligible.
- ≥50kg in weight at the start of double-blind phase (Visit 2).
- Inpatient or outpatient; however, the hospitalization status must remain unchanged during the double-blind phase. NOTE: Subjects may be hospitalized for ≤10 days after injection during the treatment period.
- Written informed consent from the subject him/herself. If the subject's signature is not legible, the attendance of a witness is required.
Exclusion criteria:
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Bilateral hemiplegia or quadriplegia.
- Presence of fixed contractures of the ankle (absence of range of motion).
- Profound atrophy of the muscles to be injected.
- Previous surgical intervention, phenol block, ethanol block, or Muscle Afferent Block (MAB) for ankle spasticity.
- Casting of the study lower limb within 3 months prior to the start of double-blind phase (Visit 2).
- Current treatment with intrathecal baclofen.
- Use of peripheral muscle relaxants (dantrolene sodium, suxamethonium chloride, pancuronium bromide, vecuronium bromide, rocuronium bromide).
- Concurrent use of antibiotics that interfere with neuromuscular transmission, such as aminoglycoside antibiotics (e.g., streptomycin sulfate, kanamycin sulfate, gentamicin sulfate, neomycin sulphate, spectinomycin hydrochloride), polypeptide antibiotics (e.g., polymixin B sulfate), lincomycin antibiotics (e.g., lincomycin hydrochloride, clindamycin), and enviomycin sulfate.
- Previous or current botulinum toxin therapy of any serotype.
- Diagnosis of systemic neuromuscular disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis).
- Females who are pregnant, nursing, may be pregnant, or planning a pregnancy during the study period.
- Known allergy or hypersensitivity to any ingredient of study medication (e.g., human serum albumin).
- Presence of psychiatric disorder or impairment of intellectual function that may interfere with the subject's ability to give informed consent or the conduct of the study.
- Bedridden patients.
- Presence of clinically unstable severe cardiovascular disease.
- Presence of clinically significant severe renal or hepatic disease.
- Infection or dermatological condition at the proposed injection sites.
- Previous or planned participation in another clinical study (including the upper limb spasticity study of GSK1358820) within 6 months prior to the start of double-blind phase (Visit 2).
- Others whom the investigator or sub investigator considers not eligible for the study.
- Clinically significant severe reduction of muscle strength.
- Angle closure glaucoma or its preposition (narrow angle).
Trial location(s)
Showing 1 - 6 of 20 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-24-12
Actual study completion date
2008-24-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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