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Dysport® Adult Lower Limb Spasticity Study

This study is currently recruiting participants.
Verified March 2013 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249404
First received: November 25, 2010
Last updated: March 31, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.


Condition Intervention Phase
Leg Spasticity
 Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Double-blind, Prospective, Randomized, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Walking speed [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport 1000 U, IM
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
 Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 (single treatment cycle)
Experimental: Dysport 1500 U, IM
1500 U, I.M., on day 1 (single treatment cycle)
 Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 (single treatment cycle)
Placebo Comparator: Placebo
I.M., on day 1 (single treatment cycle)
 Drug: Placebo
I.M. injection on day 1 (single treatment cycle)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged 18 to 80 years of age
  • Post stroke or brain injury
  • Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
  • Ambulatory patients

Exclusion Criteria:

  • Fixed contractures
  • Physiotherapy initiated less than 4 weeks before entry
  • Previous surgery or previous treatment with phenol and/or alcohol in lower limb
  • Neurological/neuromuscular disorders which may interfere with protocol evaluations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249404

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 60 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01249404     History of Changes
Other Study ID Numbers: Y-55-52120-140, 2009-015868-34
Study First Received: November 25, 2010
Last Updated: March 31, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministry of Health
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
Portugal:Infarmed (Autoridaede Nacional do Medicamento e Produtos de saudes LP)
Hungary: GYEMSZI

Additional relevant MeSH terms:
Muscle Spasticity
Brain Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
 Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013