Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Ble… (NCT00234507) | Clinical Trial Compass
CompletedPhase 2
Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
United States120 participantsStarted 2003-01
Plain-language summary
The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.