Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00276315

Purpose

To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.

Condition	Intervention	Phase
Hemifacial Spasm	Drug: Botulinum type A toxin (Dysport®) - one single injection	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicentre, Randomised, Assessor-Blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm

Resource links provided by NLM:

MedlinePlus related topics: Botox

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) [ Time Frame: At the end of week 4 ]

Secondary Outcome Measures:

Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication) [ Time Frame: At the end of week 1 and 12 ]
Improvement degree of spasm (Jankovic scale) [ Time Frame: At the end of week 1, 4 and 12 ]
Assessment of efficacy by the subjects [ Time Frame: At the end of week 1, 4 and 12 ]

Estimated Enrollment:	348
Study Start Date:	December 2005
Study Completion Date:	January 2007

Eligibility

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

Criteria

Inclusion Criteria:

Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
Cohen scale ≥ to grade II

Exclusion Criteria:

Botulinum toxin type A treatment history within last 16 weeks prior to visit 1
Hemifacial spasm secondary to facial palsy
Previous alcohol or phenol injections or surgical therapy of the facial muscles
Requirement for botulinum toxin injection to site(s) of the body other than in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276315

Locations

China
Neurology Department, Peking Union Medical College Hospital
Beijing, China, 100730
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, China, 310016
Neurology Department, Shanghai Ruijin Hospital
Shanghai, China, 200025
Neurology Department, Guangdong Provincial People's Hospital
Guangdong, China, 510080

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Jing-dong Ma, MD

Ipsen

More Information

No publications provided

Study ID Numbers:	A-38-52120-074
Study First Received:	January 12, 2006
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00276315 History of Changes
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Spasm
Mouth Diseases
Neuromuscular Manifestations
Nervous System Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions

Hemifacial Spasm
Signs and Symptoms
Neurologic Manifestations
Stomatognathic Diseases
Peripheral Nervous System Agents
Botulinum Toxin Type A

ClinicalTrials.gov processed this record on February 08, 2010