Daxxify for Facial Twitching

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a treatment called Daxxify (DaxibotulinumtoxinA) can help people with facial twitching conditions like benign essential blepharospasms (BEB) and hemifacial spasms (HFS). Researchers aim to determine if Daxxify significantly reduces twitching compared to patients' experiences with Botox. Suitable participants have BEB or HFS, have not undergone surgery for these conditions, and are not taking certain neurological medications. As a Phase 4 trial, Daxxify is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

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 is the safety track record for Daxxify?

Research shows that Daxxify, also known as DaxibotulinumtoxinA, is being tested for safety in treating facial twitching conditions such as benign essential blepharospasms (BEB) and hemifacial spasms (HFS). Although specific safety data for Daxxify in these conditions is not yet available, this Phase 4 study indicates that Daxxify has already demonstrated a good safety record in earlier trials and possibly in other treatments.

Similar treatments, like Botox, have been safely used for conditions like BEB over the long term, suggesting that Daxxify might also be well-tolerated. Participants should report any side effects to the study team to ensure ongoing safety monitoring. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for facial twitching, such as Botox, DaxibotulinumtoxinA, marketed as Daxxify, offers longer-lasting results. Researchers are excited because while most treatments require repeat injections every few months, Daxxify has the potential to extend the time between treatments, possibly reducing the frequency to twice a year. This durability is due to a unique peptide technology that stabilizes the botulinum toxin, providing sustained muscle relaxation.

What is the effectiveness track record for Daxxify in treating benign essential blepharospasms and hemifacial spasms?

Research has shown that DaxibotulinumtoxinA (Daxxify) effectively treats facial spasms. Studies have found it reduces symptoms in people with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). Patients often experience better muscle control and less twitching. In this trial, participants with either BEB or HFS will receive Daxxify to evaluate its effectiveness for these conditions. Daxxify is already approved for treating frown lines, and its effects last longer than some other treatments. This suggests it might also provide lasting relief for facial twitching conditions like BEB and HFS. Overall, the evidence supports Daxxify as a promising option for managing these conditions. ^{1 2 3 6 7}

Who Is on the Research Team?

Anne Barmettler, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06195241?cond=%22Benign%20essential%20blepharospasm%22&rank=2

Effects of DaxibotulinumtoxinA for Blepharospasm and ... The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and ...

2. app.trialscreen.org app.trialscreen.org/trials/phase-4-effects-daxibotulinumtoxina-blepharospasm-hemifacial-spasm-trial-nct06195241

Effects of DaxibotulinumtoxinA for Blepharospasm and ... Participants may experience relief or improvement in their blepharospasm or hemifacial spasm symptoms from the Daxxify treatment. They will also contribute to ...

3. trialx.com trialx.com/clinical-trials/listings/314992/effects-of-daxibotulinumtoxina-for-blepharospasm-and-hemifacial-spasm/

Effects of DaxibotulinumtoxinA for Blepharospasm and ... The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8875585/

Ultra-Long-Term Therapy of Benign Essential ... Aim of this study was to investigate the long-term results of botulinum toxin A (BoNT-A) injections for the treatment of benign essential ...

5. withpower.com withpower.com/trial/phase-4-hemifacial-spasm-1-2024-5b677

Daxxify for Facial Twitching Research shows that DaxibotulinumtoxinA is effective in treating glabellar lines (frown lines between the eyebrows) with a prolonged duration of response, ...

6. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40025&ver=8

Proposed LCD - Botulinum Toxins (DL33274) The conclusion of these studies signifies botulinum neurotoxin may be considered as a treatment for hemifacial spasm. Botox and Dysport have level C evidence ...

7. aetna.com aetna.com/cpb/medical/data/100_199/0113.html

Botulinum Toxin - Medical Clinical Policy Bulletins Safety and effectiveness have not been established in patients under age 18. Treatment of strabismus and blepharospasm associated with dystonia, including ...