JCP Study of Investigation of Patient Background Characteristics
|ClinicalTrials.gov Identifier: NCT01332474|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment|
|Spasticity, Post-Stroke||Drug: BOTOX|
- 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.
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||326 participants|
|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|
|Study Start Date :||May 2010|
|Primary Completion Date :||August 2010|
|Study Completion Date :||August 2010|
treatment of Equinus Foot due to Lower Limb Spasticity in Juvenile Cerebral Palsy Patients Aged 2-year or Older
- compare JCP patients 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. [ Time Frame: 2010/5/1-2010/8/31 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332474
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|