Status:
COMPLETED
Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
Lead Sponsor:
Ipsen
Conditions:
Blepharospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2004
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00234507
Start Date
January 1 2003
End Date
May 25 2004
Last Update
July 29 2019
Active Locations (14)
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1
Banner Health Research Institute
Phoenix, Arizona, United States, 85006
2
Neurological Institute
Phoenix, Arizona, United States, 85013
3
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
4
UCLA/Jules Stein Eye Institute
Los Angeles, California, United States, 90095