DaxibotulinumtoxinA for Blepharospasm
(BLEXI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests DaxibotulinumtoxinA (DAXI) for its effectiveness in treating blepharospasm, a condition that causes uncontrollable blinking and muscle spasms around the eyes, affecting vision and daily life. The study will observe the duration of DAXI's effects and monitor any side effects. Individuals who receive regular botulinum toxin injections for severe blepharospasm and experience benefits lasting less than 12 weeks may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Do I have to stop taking my current medications for the trial?
The trial requires that participants keep their current oral medications for dystonia stable for the duration of the study. Additionally, certain medications that might interfere with neuromuscular transmission should not be used within 14 days before the trial starts.
Is there any evidence suggesting that DaxibotulinumtoxinA is likely to be safe for humans?
Research has shown that DaxibotulinumtoxinA (DAXI) is generally safe for individuals with blepharospasm, a condition causing uncontrollable blinking or eyelid twitching. Studies have found significant symptom improvements in patients. No new safety issues have emerged with its use. Like other similar treatments, possible side effects include droopy eyelids, double vision, or dry eyes, but these are usually mild and temporary. DAXI is already approved for other conditions, indicating a well-understood safety profile. This builds confidence in its safety for treating blepharospasm.12345
Why do researchers think this study treatment might be promising?
DaxibotulinumtoxinA is unique because it offers a longer-lasting alternative to existing treatments for blepharospasm, such as onabotulinumtoxinA and incobotulinumtoxinA. Researchers are excited about this treatment because it has the potential to maintain muscle relaxation for a more extended period, reducing the frequency of injections needed. Additionally, it uses a novel formulation that might provide more consistent results, which could improve quality of life for patients dealing with frequent eyelid muscle spasms.
What evidence suggests that DaxibotulinumtoxinA might be an effective treatment for blepharospasm?
Research has shown that DaxibotulinumtoxinA (DAXI) effectively treats blepharospasm, a condition causing uncontrollable muscle spasms around the eyes. Studies have found that DAXI can provide long-lasting symptom relief, sometimes allowing for longer intervals between injections compared to other treatments. Trials demonstrated that DAXI is safe and well-tolerated, with side effects similar to or fewer than those of traditional botulinum toxin treatments. Early findings suggest it not only controls symptoms better but also offers the convenience of less frequent dosing. This makes DAXI a promising option for effectively managing blepharospasm.34678
Are You a Good Fit for This Trial?
This trial is for adults with blepharospasm (uncontrolled eyelid twitching) who currently get botulinum toxin injections but don't get enough benefit from them and can't increase their dose due to side effects. Participants must be able to consent, not have serious heart or lung problems, certain nerve/muscle diseases, unstable mental health issues, or allergies to the treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycle 1
Participants receive the first cycle of DAXI injections, with follow-up assessments to evaluate peak response and symptom control.
Treatment Cycle 2
Participants receive the second cycle of DAXI injections, with follow-up assessments similar to the first cycle.
Follow-up
Participants are monitored for safety and effectiveness after the final treatment cycle.
What Are the Treatments Tested in This Trial?
Interventions
- DaxibotulinumtoxinA
Trial Overview
The study tests DaxibotulinumtoxinA (DAXI), a type of botulinum toxin A injection, in adults with blepharospasm. All participants receive DAXI injections every 3–6 months over about a year. The main goal is to see how long each treatment lasts and monitor safety.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The study cohort will consist of adults with blepharospasm who previously received onabotulinumtoxinA or incobotulinumtoxinA and will transition to DAXI 12 weeks after their last botulinum toxin treatment. Each participant will receive a DAXI dose equivalent to their prior therapy, using a 1:1 conversion for onabotulinumtoxinA or a 1.5:1 conversion for incobotulinumtoxinA, adjusted if prior treatment caused excessive weakness or other side effects. Injections will be limited to muscles directly involved in blepharospasm (the orbicularis oculi, corrugators, procerus, and nasalis) and will use a dilution of 10 units per 0.1 mL. Subjects may use topical anesthetics to reduce injection pain, and efforts will ensure the same injector administers all treatments to maintain consistency.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Revance Therapeutics, Inc.
Industry Sponsor
Citations
Patient Characteristics and Real-World Use of Botulinum ...
We sought to describe patient characteristics, BoNT utilization, and potential adverse events (AEs) among patients with cervical dystonia, blepharospasm, and ...
High Dose AbobotulinumtoxinA for Blepharospasm
Primary outcomes included the duration of effect and frequency of booster injections, while secondary outcomes assessed the latency of effect, clinical efficacy ...
DaxibotulinumtoxinA for Blepharospasm - ClinicalTrials.Veeva
This study aims to provide real-world information about the duration, safety, and overall benefit of DaxibotulinumtoxinA (also called DAXI) ...
DaxibotulinumtoxinA for Blepharospasm
This study aims to provide real-world information about the duration, safety, and overall benefit of DaxibotulinumtoxinA (also called DAXI) treatment for ...
5.
movementdisorders.onlinelibrary.wiley.com
movementdisorders.onlinelibrary.wiley.com/doi/abs/10.1002/mdc3.70104Long‐Term Safety and Efficacy of Repeat Treatments with ...
DAXI was safe and efficacious over repeated treatments in adults with CD. Adverse event rates were similar to or potentially lower compared with conventional ...
High Dose AbobotulinumtoxinA for Blepharospasm - PMC
Across these trials, patients experienced statistically significant improvements in symptoms, and treatment was generally well tolerated. The ...
Clinical Study on the Use of Botulinum Toxin for ... - PMC
This study aimed to evaluate the efficacy, safety, and tolerability of BoNT in patients with blepharospasm and hemifacial spasm. 3. MATERIAL AND METHODS.
Efficacy and Safety of IncobotulinumtoxinA for the ...
This study demonstrated the sustained efficacy of incobotulinumtoxinA at a maximum dose of 100 U in Japanese patients with blepharospasm without new safety ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.