Last updated: 11/03/2018 16:28:25
JCP study of investigation of Patient Background Characteristics
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: 2010/5/1-2010/8/31
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
326
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Spasticity, Post-Stroke
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
May 2010 to October 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
No
- Background factors:
- The following background characteristics will be compared between the patients collected during the investigation and the patients whose deaths or ADRs related to the possible spread of toxin are reported through the spontaneous ADR reporting system, to discuss the potential risk factors for death or spread of toxin:
- patients whose adverse drug reactions (ADRs)
Inclusion and exclusion criteria
Inclusion criteria:
- Background factors: The following background characteristics will be compared between the patients collected during the investigation and the patients whose deaths or ADRs related to the possible spread of toxin are reported through the spontaneous ADR reporting system, to discuss the potential risk factors for death or spread of toxin: (a)severity of indication (cerebral palsy) prior to use of BOTOX (b)Medical history/concurrent medical conditions (e.g., dysphagia, seizure, pulmonary disorder, neuromuscular disorder, and cardiac disorder, and others) ; Yes/No, and if yes, specify the diseases (c)Use of concomitant drugs and non-drug therapies (d)Dose per kg body weight (e)Dose per injection site (e.g., gastrocnemius muscle, soleus muscle, tibialis posterior muscle)
Exclusion criteria:
- patients whose adverse drug reactions (ADRs)
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
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
2010-21-10
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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