Last updated: 11/07/2018 11:46:47

Investigation of clinical use of onabotulinumtoxinA for the treatment of upper and/or lower limb spasticity in poststroke patients with spastic hemiplegia

GSK study ID
200395
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Investigation of clinical use of onabotulinumtoxinA for the treatment of upper and/or lower limb spasticity in poststroke patients with spastic hemiplegia
Trial description: This is a multicenter retrospective study to investigate the usage of onabotulinumtoxinA in clinical practice based on the medical records in Japanese poststroke patients with spastic hemiplegia who received onabotulinumtoxinA for the treatment of upper and/or lower limb spasticity. The study will be conducted in medical institutions with physicians with expertise in the treatment of spasticity by use of onabotulinumtoxinA in order to ensure collection of data that will contribute to establishment of the standard treatment for Japanese patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Dose per muscle

Timeframe: 1/1/2012-30/11/2013

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
307
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Akio Kimura, Masahiro Abo, Yoshihisa Masakado, Yoshiyuki Yamashita, Toshio Maeda. A Clinical Investigation of Post-stroke Hemiplegic Patients with Upper and/or Lower Limb Spasticity Treated with Botulinum Toxin Type A. Japan J Rehab Med. 2015;52(7):421-430.
Medical condition
Spasticity, Post-Stroke
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
March 2014 to August 2014
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
none
  • Poststroke patients with spastic hemiplegia who received onabotulinumtoxinA injection for the treatment of upper or lower limb spasticity during the investigation period from 1 January 2012 to 30 November 2013. Patients who received onabotulinumtoxinA injection into both the upper and lower limbs concurrently can be enrolled.
  • Japanese male or female patients 20 years or older at the time of the first injection of onabotulinumtoxinA during the investigation period
  • Patients with bilateral paralysis and/or spasticity
  • Patients in whom onabotulinumtoxinA is contraindicated as specified in the package insert of onabotulinumtoxinA
Inclusion and exclusion criteria
Inclusion criteria:
  • Poststroke patients with spastic hemiplegia who received onabotulinumtoxinA injection for the treatment of upper or lower limb spasticity during the investigation period from 1 January 2012 to 30 November 2013. Patients who received onabotulinumtoxinA injection into both the upper and lower limbs concurrently can be enrolled.
  • Japanese male or female patients 20 years or older at the time of the first injection of onabotulinumtoxinA during the investigation period
  • Patients who experienced stroke at least 6 months before the first injection of onabotulinumtoxinA during the investigation period
  • Patients with a complete set of records on dates of onabotulinumtoxinA injection, muscles injected, and dose of onabotulinumtoxinA per muscle during the investigation period
  • Patients who received onabotulinumtoxinA injection and have a pre-injection Modified Ashworth Scale (MAS) score
Exclusion criteria:
  • Patients with bilateral paralysis and/or spasticity
  • Patients in whom onabotulinumtoxinA is contraindicated as specified in the package insert of onabotulinumtoxinA
  • Patients who received any botulinum toxin preparation other than onabotulinumtoxinA within 3 months before any onabotulinumtoxinA injection during the investigation period
  • Patients who received nerve block with phenol or alcohol within 6 months before any onabotulinumtoxinA injection during the investigation period
  • Patients who were on intrathecal baclofen therapy
  • Any other patients who are considered ineligible for the study by the investigator (or subinvestigator).

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-01-08

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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