A Phase 2 interventional study of Botulinum toxin type A in Blepharospasm, sponsored by Ipsen. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Ipsen · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 120 is above the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Also known as: AbobotulinumtoxinA (Dysport®)
The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
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Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A