Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Patients

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A 48-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of, 100 unit of Abobotulinum Toxin Type A (Dysport) and 33.33 unit of Neubotulinum Toxin Type A (Neuronox) injection for Hemifacial Spasm in patient diagnosed with Hemifacial Spasm according to clinical diagnosis. It was designed to evaluate the efficacy, safety, tolerability, quality of life and the comparesion the improvement after treatment by of Abobotulinum Toxin Type A (Dysport) injection versus Neubotulinum Toxin Type A (Neuronox) Injection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rajavithi Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• The subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject.

• Able to give written inform consent and retained one copy of the consent form

• Male or female subject, aged between 20 - 100 years old.

• Subject diagnosed to be hemifacial spasm.

• Female subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).

• Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.

Subject should undergo a normal physical and neurological examination HFS 30, AIMS, SF36, and CES-D, PHQ 9 , and patient diary

Exclusion Criteria:

• The subject was pregnant or lactating.

• The subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.

• The subject had a known hypersensitivity to any of the test materials or related compounds.

• The subject was unable or unwilling to comply fully with the protocol.

• The subject received any unlicensed drug within the previous 6 months.

• Treatment with investigational drug (s) within 6 months before the screening visit.

• The subject had previously entered in this study.

• Subject with past history of botulism, other neuromuscular disorder (e.g. myasthenia gravis, Lambert - Elton Syndrome)

• Subject with significant medical / neurological / psychiatric disorders such as blood dyscrasia, thrombocytopenia, INR>1.2 rheumatoid arthritis, congestive heart failure, coronary artery heart diseases, dementia, psychosis, or other conditions which could influence the clinical trial.

• Known history of drug abuse (narcotic (s), cafergot, or others) or drug (botulinum toxin type A) allergy.

• Unable to cooperate fill-up HFS 30, AIMS, SF36, and CES-D

• Patient who planned to schedule elective surgery during the study.

• The used of aminoglycoside antibiotics and curare were not allowed during the study.