Brief Title
Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
Official Title
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
Brief Summary
The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo
by assessing functional disability in blepharospasm.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
Secondary Outcome
Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
Condition
Blepharospasm
Intervention
Botulinum toxin type A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
120
Start Date
January 2003
Completion Date
May 25, 2004
Primary Completion Date
May 25, 2004
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Study Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00234507
Organization ID
Y-47-52120-706
Study Sponsor
Ipsen
Study Sponsor
Ipsen Study Director, Study Director, Ipsen
Verification Date
July 2019