CompletedPhase 4

The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.

South Korea249 participantsStarted 2015-04-30

Plain-language summary

The purpose of this study is evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men and women at the age of 18 or older
✓. Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
✓. Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
✓. Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study

✕. Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
✕. Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
✕. Subjects with secondary blepharospasm
✕. Subjects with the hemifacial spasm
✕. Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
✕. Subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin HCl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics)
✕. Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
✕. Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis

Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale

Timeframe: At 4 weeks post-injection

NCT IDNCT03641950

SponsorHugel

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men and women at the age of 18 or older
✓. Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
✓. Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
✓. Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study

✕. Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
✕. Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
✕. Subjects with secondary blepharospasm
✕. Subjects with the hemifacial spasm
✕. Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
✕. Subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin HCl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics)
✕. Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
✕. Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis