A phase IV randomised, placebo controlled, double-blind, single centre, out-patient trial to investigate the functional benefit of botulinum toxin injections combined with physiotherapy treatment for spasticity of the upper limb after stroke - PrOMBiS (Predicting Outcome and Measuring Benefit from Botulinum toxin in Stroke)

• Conditions: upper limb spasticity after stroke; MedDRA version: 9.1Level: LLTClassification code 10048863Term: Hemorrhagic stroke; MedDRA version: 9.1Level: LLTClassification code 10014498Term: Embolic stroke; MedDRA version: 9.1Level: LLTClassification code 10023027Term: Ischaemic stroke NOS; MedDRA version: 9.1Level: LLTClassification code 10027580Term: Middle cerebral artery stroke; MedDRA version: 9.1Level: LLTClassification code 10019016Term: Haemorrhagic stroke; MedDRA version: 9.1Level: LLTClassification code 10042244Term: Stroke; MedDRA version: 9.1Level: LLTClassification code 10043647Term: Thrombotic stroke; MedDRA version: 9.1Level: LLTClassification code 10055221Term: Ischemic stroke; MedDRA version: 9.1Level: LLTClassification code 10057613Term: Thromboembolic stroke

• Registration Number: EUCTR2009-009357-22-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• clinically confirmed diagnosis of stroke;
• more than one month post-stroke;
• established focal finger or wrist spasticity with an Ashworth score of 2 or more;
• spasticity considered clinically to have potential to benefit from treatment with botulinum toxin
• the ability to pick up a mug and move it to another position (so that participants are able to use any improvement in hand control in functional reach and grasp tasks); and
• agree to comply with recommended contraceptive requirements where appropriate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• contraindications for using botulinum toxin as specified in the manufacturer’s SmPC, that is, individuals with:
- a known hypersensitivity to botulinum toxin type A or to any of the excipients
- the presence of infection at the proposed injection site(s)
• orthopaedic impairments affecting the hemiplegic upper limb or spine (e.g. recent fracture or capsulitis);
• clinical evidence of fixed contracture
• botulinum toxin to the upper limb within previous 3 months
• additional neurological impairment likely to contribute to spasticity (e.g. multiple sclerosis) or interfere with outcome measurements (e.g. visual loss);
• uncontrolled shoulder or wrist pain whilst performing the experimental tasks (e.g. due to arthritis);
• severe cognitive impairment preventing informed consent and/or the ability to follow task instructions;
• the use of aminoglycoside antibiotics or spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. tubocararine-type muscle relaxants)
• anti-coagulation with an INR of > 2 or other contraindication to intramuscular injection; and
• pregnant or lactating women (or those at risk of pregnancy but not willing to to take adequate precautions to prevent pregnancy during the trial)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified