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Clinical Trials/EUCTR2009-015868-34-BE
EUCTR2009-015868-34-BE
Active, not recruiting
Not Applicable

A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED STUDY, ASSESSING THE EFFICACY AND SAFETY OF DYSPORT USED FOR THE TREATMENT OF LOWER LIMB SPASTICITY IN ADULT SUBJECTS WITH HEMIPARESIS DUE TO STROKE OR TRAUMATIC BRAIN INJURY.

Ipsen Pharma SAS0 sites348 target enrollmentDecember 16, 2010
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Conditionseg SpasticityMedDRA version: 14.1Level: LLTClassification code 10024132Term: Leg spasticitySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsDYSPORT™ for Injection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
eg Spasticity
Sponsor
Ipsen Pharma SAS
Enrollment
348
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 16, 2010
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)
  • •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.

Outcomes

Primary Outcomes

Not specified

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EUCTR2009-015868-34-CZIpsen Pharma SAS348