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CompletedNCT01332474Updated Jun 7, 2017

JCP Study of Investigation of Patient Background Characteristics

An observational study in Spasticity, Post-Stroke, sponsored by GlaxoSmithKline. Completed. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2017-06-07.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
326
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Spasticity, Post-Stroke

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Keywords

  • Botox
  • JCP
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 326 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients aged 2-year or older

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

Exclusion Criteria:

  • patients whose adverse drug reactions (ADRs)
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
326 participants (actual)

Groups and cohorts

  • JCP

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

    Drug: BOTOX

Interventions

  • DrugBOTOX

    BOTOX

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01332474
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 11, 2011
Start date
May 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Jun 7, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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