JCP Study of Investigation of Patient Background Characteristics

NCT01332474 | Completed

• 1 other identifier: 114324
• Study Type: observational
• Target: 326
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spasticity, Post-Stroke

Keywords

Botox; JCP

Outcome Measures

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.

  2010/5/1-2010/8/31

Study Arms (1)

JCP

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

Drug: BOTOX

Interventions

BOTOX DRUG

BOTOX

JCP

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients aged 2-year or older

You may qualify if:

• 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:
• 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)

You may not qualify if:

• patients whose adverse drug reactions (ADRs)

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 7, 2017

Record last verified: 2017-06