A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of lower limb spasticityin adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.
- Conditions
- eg SpasticityMedDRA version: 14.1Level: LLTClassification code 10024132Term: Leg spasticitySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2009-015868-34-BE
- Lead Sponsor
- Ipsen Pharma SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 348
•Provision of written informed consent prior to any study related procedures.
•Subjects with hemiparesis and between 18 and 80 years of age, inclusive.
•Subjects who had only one clinically defined stroke episode, as defined by the World Health Organisation (WHO) criteria or who have had one brain trauma.
•Toxin naïve subjects who have a MAS score = 2 in the affected GSC (knee extended) or toxin non naïve subjects who have a MAS score = 3 in the affected GSC (knee extended) at least four months after the last injection of BTX in the affected lower limb.
•Ambulatory subjects with spastic hemiparesis that causes a gait deficiency with a comfortable barefoot walking speed between 0.1m/s and 0.8m/s at baseline as measured on a 10 metre comfortable walking test without walking aids.
•Subjects who are at least 6 months post-stroke or post-brain trauma.
•Spasticity angle > 5° for the GSC of the affected leg as measured by the Tardieu scale (TS),(knee extended).
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 191
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 157
•Major limitation in the passive range of motion at the affected hip, knee or ankle, as defined by:
omaximum passive hip flexion (knee flexed) < 30°,
omaximum passive knee flexion (hip flexed) < 70°
omaximum passive ankle dorsi-flexion (knee flexed)
<-10°
omaximum passive knee extension < 160°.
•Physiotherapy initiated less than 4 weeks before entry or expected to be initiated during the trial.
•Previous treatment with BTX of any type within four months prior to study entry for any condition.
•Subjects likely to be treated with BTX of any type in the upper limb during the course of this double blind study.
•Previous primary or secondary non responder to any Botulinum toxins for any condition.
•Previous surgery to treat spasticity of the affected lower limb.
•Previous treatment with phenol and/or alcohol in lower limb at any time before the study.
•Cognitive impairment altering the capacity to comply with the trial according to Investigator’s judgement.
•Severe neurological impairment (not associated with the stroke or brain trauma) due to an underlying neuromuscular disease or any other underlying disease or condition affecting gait (e.g. Multiple Sclerosis)
•Known disease of the neuromuscular junction (such as Lambert-Eaton disease or myasthenia gravis).
•Unwillingness or inability to comply with the protocol.
•Major hypoaesthesia or ataxia on the paretic side.
•Known sensitivity to BTX or any Dysport excipients.
•Infection at the injection site(s).
•Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycosides) within the last 4 weeks prior to study treatment.
•Pregnant women, or pre-menopausal women not willing to use contraceptive measures throughout the duration of the study.
•Treatment with a new investigational drug within 4 weeks prior to enrolment into the study or scheduled treatment with such a drug during the study period.
•Any medical condition (or laboratory finding), that in the opinion of the Investigator may compromise compliance with the objectives and/or procedures of this protocol or preclude the administration of BTX.
•Subjects treated or likely to be treated with intrathecal baclofen during the course of the study or during the 4 weeks before study entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary study objective is to assess the efficacy of Dysport compared to placebo at Week 4 on the change from baseline in the gastrocnemius-soleus complex (GSC) muscle tone (knee extended) in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.;Secondary Objective: The secondary study objectives will include assessments of the efficacy of Dysport compared to placebo on changes in the Physician’s Global Assessment (PGA) of treatment response and comfortable barefoot walking speed.;Primary end point(s): •Mean change from baseline in the muscle tone measured in the GSC (knee extended) on the MAS ;Timepoint(s) of evaluation of this end point: Week 4.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Mean Physician’s Global Assessment Score <br>• Mean change from baseline in comfortable barefoot walking speed without walking aids ;Timepoint(s) of evaluation of this end point: Week 4