Daxxify for Facial Twitching

Overseen By Ricky Paramo, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must be taking: Botox

Must not be taking: Neurologic medications

Disqualifiers: Age < 18, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 9 months

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not have any known neurologic or neuromuscular systematic medications. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug DaxibotulinumtoxinA for facial twitching?

Research shows that DaxibotulinumtoxinA is effective in treating glabellar lines (frown lines between the eyebrows) with a prolonged duration of response, suggesting it may also help with facial twitching due to its similar mechanism of action. ^{1 2 3 4 5}

Is Daxxify (DaxibotulinumtoxinA) generally safe for humans?

The research articles provided do not contain specific safety data for Daxxify (DaxibotulinumtoxinA) or its use in treating facial twitching. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to answer: 1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify? 2. What percentage of patients achieve a clinical response? Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

Research Team

Anne Barmettler, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Eligibility Criteria

This trial is for individuals with benign essential blepharospasm (BEB) or hemifacial spasm (HFS), diagnosed by an ophthalmologist, who haven't had surgery for these conditions. Participants should not be taking neurologic or neuromuscular medications.

Inclusion Criteria

I have been diagnosed with BEB or HFS by an eye doctor.

I have never had surgery for eye or facial spasms.

I am not taking any medications for nerve or muscle disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DaxibotulinumtoxinA-Lanm (Daxxify) treatment, with effects observed within 48-72 hours

Up to 9 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with therapeutic response measured using the Jankovic Rating Scale

4 weeks

1 visit (in-person)

Extension

Participants may continue to receive treatment if symptom-free, with monitoring for waning and loss of efficacy

Up to 9 months

Treatment Details

Interventions

• DaxibotulinumtoxinA

Trial Overview The trial tests DaxibotulinumtoxinA-Lanm (Daxxify) on patients with BEB and HFS. It aims to see if there's a significant difference in twitching severity using the Jankovic Rating Scale after treatment, and how many patients show improvement.

Participant Groups

Group I: Benign Essential Blepharospasm or Hemifacial Spasm Experimental Treatment 1 Intervention

Patients with either Benign Essential Blepharospasms or Hemifacial Spasms

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Revance Therapeutics, Inc.

Industry Sponsor

Trials

32

Recruited

6,600+

Findings from Research

In a study involving 568 adults with moderate to severe dynamic glabellar lines, repeated treatments with DaxibotulinumtoxinA (DAXI) led to a significant increase in the number of subjects showing no static glabellar lines, with improvements observed after each treatment cycle.

The results suggest that DAXI not only effectively reduces dynamic glabellar lines but also promotes long-term benefits through muscle inactivity, allowing for dermal remodeling over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection. Glogau, R., Kontis, TC., Liu, Y., et al.[2023]

In two phase 3 studies involving 609 subjects, DaxibotulinumtoxinA (DAXI) demonstrated significant efficacy in reducing glabellar line severity compared to placebo, with 73.6% and 74.0% of subjects showing at least a 2-point improvement at week 4.

DAXI provided a prolonged duration of effect, maintaining reduced glabellar line severity for a median of 24 weeks, and was generally well tolerated, with common side effects being mild headaches and injection-site pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Carruthers, JD., Fagien, S., Joseph, JH., et al.[2022]

In a study involving 2737 patients, DaxibotulinumtoxinA-lanm (DAXI) showed a low immunogenic potential, with only 0.8% developing treatment-related nonneutralizing antibodies, which did not affect clinical efficacy.

Patients who developed transient binding antibodies still achieved a clinical response with no significant difference in treatment duration compared to those without antibodies, indicating that DAXI remains effective even in the presence of these antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines. Humphrey, S., Dover, JS., Bowsher, RR., et al.[2023]

A total of 5,896 adverse event reports related to botulinum toxin (BTX) were analyzed from 1999 to 2016, revealing 44 safety signals, including 7 that were not previously labeled, indicating potential risks associated with BTX treatment.

The analysis showed a significantly high reporting odds ratio for 'ineffective medicine' (21.60) and 'depression' (6.02) as adverse events, particularly among females, suggesting a need for ongoing monitoring of BTX's safety profile, especially with its increasing off-label use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signal detection of botulinum toxin type A (BoNT/A) using the Korea Adverse Event Reporting System Database, 1999 - 2016. Lee, SE., Lee, SH., Shin, JY.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Systematic analysis on clinical safety of Shuxuetong injection]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Methods for Detecting Pediatric Adverse Drug Reactions From the Electronic Medical Record. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Signal detection of botulinum toxin type A (BoNT/A) using the Korea Adverse Event Reporting System Database, 1999 - 2016. [2021]

9. China pubmed.ncbi.nlm.nih.gov

[A postmarketing surveillance study on 31,724 patients using Dengzhan Xixin injection in hospital]. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases. [2023]