A Multicentre, Double-Blind, Prospective, Randomised, European and Canadian Study to Evaluate Patient Outcomes and Costs of Managing Adults with Spasticity and Associated Focal Spasticity. - BOTOX® Economic Spasticity Trial (BEST)

• Conditions: Spasticity and Associated Focal Spasticity; MedDRA version: 9.1Level: LLTClassification code 10041416Term: Spasticity

• Registration Number: EUCTR2007-000735-26-SE
• Lead Sponsor: Allergan Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Male or female patients between 18 and 85 years of age
2.Patients with stroke due to a primary cerebral haemorrhage/ infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia
3.Patients suitable for botulinum toxin type A (BOTOX®)
4.Patients with documented focal/multifocal problems of spasticity in the upper and/or lower limbs and for who functional gains are anticipated after treatment with BOTOX® + SC

•Patients treated for upper limb spasticity: evidence of preserved antagonist function and at least one item of the REsistance to PAssive movement Scale (REPAS) with a score of at least 1 at the relevant joint(s) for the primary endpoint
•Patients treated for lower limb spasticity: evidence of preserved standing/ambulation function and at least one item of the REPAS with a score of at least 1 at the relevant joint(s) for the primary endpoint
5.Patients with spasticity, as defined in criterion #4 above, caused by a stroke that happened 3 months or more before the Screening visit
6.Female patients either surgically sterile (has had a tubal ligation, documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test is negative and agree to use birth control (e.g. hormonal contraception [estrogen or progesterone agents], intrauterine contraceptive device, double barrier methods [condom with spermicide, diaphragm with spermicide, or male condom and diaphragm], or total sexual abstinence) during the study
7.Patients able to communicate effectively, with the help of a third person completing answers on their behalf (when required)
8.Patients willing and able to come to each study protocol visit and answer questions by phone on a monthly basis, possibly with the assistance of a caregiver
9.Patients willing and able to provide a signed and dated written informed consent
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

1.Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated
2.Patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)
3.Patients who have been previously treated with botulinum toxin or phenol nerve block in the limbs to be injected during this trial
4.Patients requiring concomitant use of intrathecal baclofen or phenol nerve block at any point during the study; patients requiring systemic aminoglycoside antibiotics or spectinomycin during the period from at least 3 days before until 6 weeks after injection of study medication.
5.Patients who are currently taking part in any other clinical trial or have taken part in a clinical trial of a new chemical entity within 6 months prior to Screening
6.Patients with a Mini-Mental State Examination (MMSE) < 20
7.Patients not sufficiently motivated to participate in the study as determined by an Apathy Evaluation Scale score > 40
8.Patients with known medical conditions (e.g. cardiac condition, cancer, etc.) that would affect their ability to benefit from treatment or to complete the study
9.Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
10.Patients with myasthenia gravis or Eaton Lambert Syndrome
11.Patients with infection at the proposed injection site(s)

Study & Design

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