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Completed

NCT Number: NCT01930786

An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Morvan, Brest, Finistere, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment with onabotulinumtoxinA according to the decision of the physician for spasticity
  • Willingness to complete study questionnaires and answer study questions by phone or internet

Exclusion criteria

  • Concurrent participation in a clinical trial for spasticity

Treatment and study plan

OnabotulinumtoxinA

Drug

onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.

Other names: BOTOX®, botulinum toxin Type A

Primary outcomes

  1. Percentage of Patients Reporting Satisfaction with Treatment

    Time frame: 5 Weeks

  2. Percentage of Health Care Providers Reporting Satisfaction with Treatment

    Time frame: 12 Weeks

Secondary outcomes

  1. Physical Functioning on a 5-Point Scale

    Time frame: 5 Weeks

  2. Severity of Pain on an 11-Point Scale

    Time frame: 5 Weeks

  3. Disability Assessment on a 4-Point Scale

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment

Acronym: ASPIRE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2013
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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