NCT02390206

Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients

An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A (BoNT-A) Injections in Untreated Chronic Post-stroke Spastic Brazilian Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 239 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.

Detailed description

As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician. This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice. This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.

Conditions

• Spasticity

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-08-28
• Completion: 2017-08-28
• First posted: 2015-03-17
• Last updated: 2017-10-02

Locations

11 sites across 1 country: Brazil