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NOT YET RECRUITING
NCT04589364
PHASE3

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

Sponsor: Department of Medical Services Ministry of Public Health of Thailand

View on ClinicalTrials.gov

Summary

A 50-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 100 unit of Abobotulinum Toxin Type A (Dysport®) versus 33.33 unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients, designed gor comparing the effectiveness of Total intensity score after 4. 12. 16 and 24 weeks of treatment and to compare the long-term safety of the injections. Abobotulinum toxin A (Dysport \*) dose 100 units compared ot neubotulinum toxin A injection (Neuronox / Neuronox®) dose 33.33 units. that it si non-inferiority (non-inferiority) ni the treatment of hemifacial spasm after administration of the drug ni the 0, 12" ,26", and 38" weeks ni the treatment of patients with hemi facial spasm, with a wash out period of 2 weeks between treatments. By proving the non-inferiority of Total intensity score at ,4 ,8 and12 week after treatment which calculated by severity score and duration of facial muscle spasm (hour per day)., as well as severity score and duration of functional impairment (hour per day) recorded for 4,8, and 21 weeks after each treatment between 33.33 unit of Neubotulinum Toxin Type A(Neuronox\*) and 100 unit of Abobotulinum Toxin Type A (Dysport\*)

Official title: A 50-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of100 Unit of Abobotulinum Toxin Type A (Dysport®) Versus 33.33 Unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-05-01

Completion Date

2026-08-01

Last Updated

2024-04-26

Healthy Volunteers

No

Interventions

DRUG

Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)

injection of toxin on facial muscle

Locations (4)

Rajavithi Hospital

Bangkok, Thailand

Lampang Hospital

Lampang, Thailand

Surat Thani hospital

Surat Thani, Thailand

Sappasitthiprasong Hospital

Ubon Ratchathani, Thailand