JCP Study of Investigation of Patient Background Characteristics

Completed

• Conditions: Spasticity, Post-Stroke
• Interventions: Drug: BOTOX

• Registration Number: NCT01332474
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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:

1. severity of indication (cerebral palsy) prior to use of BOTOX
2. 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
3. Use of concomitant drugs and non-drug therapies
4. Dose per kg body weight
5. Dose per injection site (e.g., gastrocnemius muscle, soleus muscle, tibialis posterior muscle)

Exclusion Criteria

• patients whose adverse drug reactions (ADRs)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JCP	BOTOX	treatment of Equinus Foot due to Lower Limb Spasticity in Juvenile Cerebral Palsy Patients Aged 2-year or Older

Primary Outcome Measures

Name	Time	Method
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.	2010/5/1-2010/8/31