CompletedNot Applicable

JCP Study of Investigation of Patient Background Characteristics

326 participantsStarted 2010-05

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

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

What they're measuring

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

Trial details

NCT IDNCT01332474

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-08

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