A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke

Terminated

• Conditions: Upper Limb Spasticity After Stroke

• Registration Number: NCT01239628
• Lead Sponsor: Ipsen

Brief Summary

The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Study Start: 2010-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Subject able to comply with the protocol
• Provision of written informed consent prior to collecting the data
• Male or female patients of 18 years or older
• Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated

Exclusion Criteria

• The subject has already been included in this survey
• Patients who already received BoNT-A treatment for upper limb spasticity
• Patients with known intolerance for BoNT-A
• Subjects unable to comply with the protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documentation of the injection intervals	3 years
Documentation of treatment modalities	3 years

Secondary Outcome Measures

Name	Time	Method
Documentation of the main reason(s) for dose change(s)	3 years
Documentation of the main reason(s) for change in injection intervals	3 years
Documentation of the physician satisfaction with the treatment	3 years
Documentation of the patient satisfaction with the treatment	3 years

Trial Locations

Locations (11)

Heilig Hart Ziekenhuis; 🇧🇪 Lier, Belgium

AZ St-Jan; 🇧🇪 Brugge, Belgium

AZ Sint Lucas; 🇧🇪 Gent, Belgium

Revalidatiecentrum St Ursula; 🇧🇪 Herk-de-Stad, Belgium

RevalidatieZiekenhuis RevArte; 🇧🇪 Edegem, Belgium

ZOL, Campus Sint Barbara; 🇧🇪 Lanaken, Belgium

CHPLT Peltzer; 🇧🇪 Verviers, Belgium

Hôpital Marie Curie; 🇧🇪 Lodelinsart, Belgium

CHU Leonardo da Vinci; 🇧🇪 Montigny-le-Tilleul, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

St- Augustinus; 🇧🇪 Antwerpen, Belgium