Special Drug Use Investigation for Botox® (Botulinum) Spasticity (BOTOX is a Registered Trademark of Allergan, Inc.)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by GlaxoSmithKline.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 7, 2011
Last updated: June 6, 2013
Last verified: August 2011

The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.

Condition Intervention
Drug: Botulinum Toxin Type A

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Botox® (Botulinum) Spasticity

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with spasticity treated with botulinum injection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurence of adverse events at remote sites [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurence of adverse events associated with pulmonary function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Onset status of adverse events associated with convulsion [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Onset status of adverse events associated with accidents such as fall [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed botulinum injection Drug: Botulinum Toxin Type A


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Japanese subjects with upper or lower limb spasticity who are treated with botulinum injection for the first time


Inclusion Criteria:

  • Subjects with upper or lower limb spasticity
  • Subjects must use botulinum injection for the first time

Exclusion Criteria:

  • Not applicable
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01390922

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390922     History of Changes
Other Study ID Numbers: 114880
Study First Received: July 7, 2011
Last Updated: June 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Muscle Spasticity
Rubulavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014