DaxibotulinumtoxinA for Blepharospasm

(BLEXI Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Pennsylvania
Must be taking: OnabotulinumtoxinA, IncobotulinumtoxinA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

I am 18 years old or older.
I have blepharospasm that needs regular botulinum toxin injections.
I get botulinum toxin shots for blepharospasm, but they help for less than 12 weeks and my dose can't be increased due to side effects.
See 1 more

Exclusion Criteria

I have a history of serious heart failure or abnormal heart rhythms.
Known hypersensitivity to botulinum toxin or formulation components
Subjects in an investigational drug or device study within the last 30 days prior to Screening
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment Cycle 1

Participants receive the first cycle of DAXI injections, with follow-up assessments to evaluate peak response and symptom control.

3-6 months
Multiple visits (in-person and remote)

Treatment Cycle 2

Participants receive the second cycle of DAXI injections, with follow-up assessments similar to the first cycle.

3-6 months
Multiple visits (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after the final treatment cycle.

3-6 months
Multiple visits (in-person and remote)

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

Group I: Open label armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Revance Therapeutics, Inc.

Industry Sponsor

Trials
32
Recruited
6,600+

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 ...

Long‐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 ...