Spasticity, Post-Stroke Clinical Trial
Official title:
BOTOX®(BOTOX is a Registered Trade Mark of Allergan, Inc) Injection 50 and 100 Treatment of Equinus Foot Due to Lower Limb Spasticity in Juvenile Cerebral Palsy Patients Aged 2-year or Older: Investigation of Patient Background Characteristics
To collect the background characteristics of juvenile cerebral palsy patients aged 2-year or older prescribed BOTOX for the treatment of equines foot due to lower limb spasticity, compare them with those of patients whose deaths or adverse drug reactions (ADRs) related to the possible spread of toxin are reported through the spontaneous ADR reporting system, and discuss potential risk factors for such ADRs.
1. In each of prospective medical institutions (where BOTOX is expected to be prescribed
annually to at least 10 juvenile cerebral palsy patients aged 2-year or older), the
Medical Representative will explain the objectives, subjects and methods of the
investigation to the prospective investigator (i.e., a physician who will prescribe
BOTOX and can comply with the protocol of the investigation) and ask for his/her
participation in the investigation.
2. When the physician agrees to participate in the investigation, a written agreement will
be concluded between GSK and the head (e.g. director) of the medical institution prior
to the start of the investigation.
3. After the completion of the investigation period, the physician will complete the case
report form (CRF) for the patients prescribed BOTOX by him/her during the investigation
period. The information of the patients who developed ADRs will be collected separately
through the spontaneous ADR reporting system on a daily basis.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01205451 -
A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
|
Phase 3 | |
| Completed |
NCT03261167 -
A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity
|
Phase 3 |