Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00234507
First received: October 5, 2005
Last updated: April 12, 2006
Last verified: April 2006

October 5, 2005
April 12, 2006
January 2003
Not Provided
The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
Same as current
Complete list of historical versions of study NCT00234507 on ClinicalTrials.gov Archive Site
  • Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
  • PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
  • Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
  • Change from baseline in BDS, FIM, severity of oculo-facial spasm and in severity of global impairment due to blepharospasm (measured by VAS) at 4, 8, 12 and 16 weeks post treatment.
  • Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
  • Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
  • Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
  • To compare the safety of each of the 3 doses of Dysport with placebo in terms of adverse event incidence, vital signs and physical examinations.
Same as current
Not Provided
Not Provided
 
Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
Phase II, Multi-Centre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection, of Three Doses of Dysport (40 Units/Eye, 80 Units/Eye, and 120 Units/Eye) for the Treatment of Benign Essential Blepharospasm

The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Blepharospasm
Drug: Botulinum toxin type A (Dysport®)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2004
Not Provided

Inclusion Criteria:

  • patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit
  • naïve patients to botulinum toxin type A treatment, or patients who had received a single treatment of botulinum toxin type A, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type A with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated
  • patients with a minimum score of 8 on the BDS

Exclusion Criteria:

  • patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia
  • previous surgical, chemical and thermal myectomy or neurectomy
  • any condition where intramuscular injection is contraindicated
  • ophthalmolgical infection
  • myasthenia gravis or other disorders of the neuromuscular junction
  • prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234507
Y-47-52120-706
Not Provided
Not Provided
Ipsen
Not Provided
Study Director: Jean-Loic Robin, MD Ipsen
Ipsen
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP