AbbVie Reports Positive Phase 2 ELATE Trial Results for BOTOX® in Essential Tremor
AbbVie (NYSE: ABBV) announced positive topline results from its Phase 2 ELATE trial, evaluating onabotulinumtoxinA (BOTOX®) for the treatment of upper limb essential tremor. The study met its primary and all six secondary endpoints, demonstrating both clinical efficacy and a favorable safety profile.
Phase 2 ELATE Trial Results
The Phase 2 ELATE trial compared onabotulinumtoxinA (BOTOX®) with placebo over 18 weeks in adults with upper limb essential tremor.
- Primary Endpoint:
- Statistically significant improvement from baseline in Tremor Disability Scale-Revised (TREDS-R) total unilateral score.
- Mean change: -2.61 for BOTOX® vs. -1.61 for placebo (p=0.029).¹ - Secondary Endpoints:
- All six were successfully met, including improvements in **activities of daily living, tremor assessment scales, and global impression scores.**²
“Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments. “No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate proof of mechanism for a neurotoxin as a potential treatment option.”
- Daniel Mikol, M.D., Ph.D., Vice President, Neuroscience Development at AbbVie.
Safety Findings
Safety analyses were consistent with the known safety profile of onabotulinumtoxinA.
- Most common adverse event: Muscular weakness (24.5% BOTOX® vs. 2.3% placebo).
- Events were localized, transient, and mostly mild or moderate in nature.¹
Results from the ELATE trial will be presented at the 2025 International Congress of Parkinson’s Disease and Movement Disorders® on October 8, 2025.
Note: The use of BOTOX® for essential tremor is not approved by the U.S. FDA or any other global regulatory authority. Safety and efficacy for this indication have not been evaluated by regulators.
About the ELATE Study
The ELATE (Evaluation of Long-Acting Tremor Efficacy) trial was a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study assessing the safety and efficacy of onabotulinumtoxinA in adults with upper limb essential tremor.
Study Highlights:
- Population: Adults with essential tremor affecting upper limbs.
- Duration: 21 weeks total (primary analysis through Week 18).
- Primary Endpoint: Change from baseline in TREDS-R total score across seven unilateral items averaged over Weeks 15, 18, and 21.
- Secondary Endpoints: Included tremor severity scales, activities of daily living (ADL) measures, and clinician global impression scores.
About Essential Tremor
Essential tremor (ET) is the most common movement disorder, affecting an estimated 25–60 million people worldwide.³
- It causes uncontrollable, involuntary shaking, most often in the hands and arms.
- ET interferes with daily tasks such as writing, eating, and dressing.
- The condition frequently leads to anxiety, depression, and social withdrawal, severely impacting quality of life.⁴
Current pharmacologic therapies—such as propranolol and primidone, often provide limited efficacy or poor tolerability, leaving many patients with unmet therapeutic needs.
About BOTOX® (onabotulinumtoxinA)
BOTOX® was first FDA-approved in 1989 for the treatment of blepharospasm and strabismus in adults. Today, it holds multiple therapeutic indications across neurology, urology, and dermatology.
U.S. FDA-Approved Indications
BOTOX® is approved for:
- Overactive bladder (adults and children 5+ years)
- Urinary incontinence due to neurologic disease
- Chronic migraine prevention (≥15 headache days/month)
- Spasticity (pediatric and adult)
- Cervical dystonia
- Strabismus and blepharospasm
- Severe primary axillary hyperhidrosis
BOTOX® is not FDA-approved for essential tremor.
Important Safety Information (U.S.)
Warning: BOTOX® may cause serious side effects that can be life-threatening. Seek immediate medical attention if you experience:
- Difficulty swallowing, speaking, or breathing
- Muscle weakness beyond the injection site
- Double or blurred vision, drooping eyelids
- Trouble urinating, loss of bladder control, or dizziness
Do not use BOTOX® if you:
- Are allergic to botulinum toxin or any of its ingredients
- Have had a reaction to other botulinum toxin products (e.g., Dysport®, Xeomin®, Myobloc®, Jeuveau®, Daxxify®, or Letybo®)
- Have a skin infection at the injection site
About AbbVie
AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines in immunology, oncology, neuroscience, and eye care, along with medical aesthetics through its Allergan Aesthetics division.
The company’s mission is to tackle serious health issues today while advancing tomorrow’s medical innovations.
AbbVie (NYSE: ABBV) announced positive topline results from its Phase 2 ELATE trial, evaluating onabotulinumtoxinA (BOTOX®) for the treatment of upper limb essential tremor. The study met its primary and all six secondary endpoints, demonstrating both clinical efficacy and a favorable safety profile.
Phase 2 ELATE Trial Results
The Phase 2 ELATE trial compared onabotulinumtoxinA (BOTOX®) with placebo over 18 weeks in adults with upper limb essential tremor.
- Primary Endpoint:
- Statistically significant improvement from baseline in Tremor Disability Scale-Revised (TREDS-R) total unilateral score.
- Mean change: -2.61 for BOTOX® vs. -1.61 for placebo (p=0.029).¹ - Secondary Endpoints:
- All six were successfully met, including improvements in **activities of daily living, tremor assessment scales, and global impression scores.**²
“Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments. “No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate proof of mechanism for a neurotoxin as a potential treatment option.”
- Daniel Mikol, M.D., Ph.D., Vice President, Neuroscience Development at AbbVie.
Safety Findings
Safety analyses were consistent with the known safety profile of onabotulinumtoxinA.
- Most common adverse event: Muscular weakness (24.5% BOTOX® vs. 2.3% placebo).
- Events were localized, transient, and mostly mild or moderate in nature.¹
Results from the ELATE trial will be presented at the 2025 International Congress of Parkinson’s Disease and Movement Disorders® on October 8, 2025.
Note: The use of BOTOX® for essential tremor is not approved by the U.S. FDA or any other global regulatory authority. Safety and efficacy for this indication have not been evaluated by regulators.
About the ELATE Study
The ELATE (Evaluation of Long-Acting Tremor Efficacy) trial was a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study assessing the safety and efficacy of onabotulinumtoxinA in adults with upper limb essential tremor.
Study Highlights:
- Population: Adults with essential tremor affecting upper limbs.
- Duration: 21 weeks total (primary analysis through Week 18).
- Primary Endpoint: Change from baseline in TREDS-R total score across seven unilateral items averaged over Weeks 15, 18, and 21.
- Secondary Endpoints: Included tremor severity scales, activities of daily living (ADL) measures, and clinician global impression scores.
About Essential Tremor
Essential tremor (ET) is the most common movement disorder, affecting an estimated 25–60 million people worldwide.³
- It causes uncontrollable, involuntary shaking, most often in the hands and arms.
- ET interferes with daily tasks such as writing, eating, and dressing.
- The condition frequently leads to anxiety, depression, and social withdrawal, severely impacting quality of life.⁴
Current pharmacologic therapies—such as propranolol and primidone, often provide limited efficacy or poor tolerability, leaving many patients with unmet therapeutic needs.
About BOTOX® (onabotulinumtoxinA)
BOTOX® was first FDA-approved in 1989 for the treatment of blepharospasm and strabismus in adults. Today, it holds multiple therapeutic indications across neurology, urology, and dermatology.
U.S. FDA-Approved Indications
BOTOX® is approved for:
- Overactive bladder (adults and children 5+ years)
- Urinary incontinence due to neurologic disease
- Chronic migraine prevention (≥15 headache days/month)
- Spasticity (pediatric and adult)
- Cervical dystonia
- Strabismus and blepharospasm
- Severe primary axillary hyperhidrosis
BOTOX® is not FDA-approved for essential tremor.
Important Safety Information (U.S.)
Warning: BOTOX® may cause serious side effects that can be life-threatening. Seek immediate medical attention if you experience:
- Difficulty swallowing, speaking, or breathing
- Muscle weakness beyond the injection site
- Double or blurred vision, drooping eyelids
- Trouble urinating, loss of bladder control, or dizziness
Do not use BOTOX® if you:
- Are allergic to botulinum toxin or any of its ingredients
- Have had a reaction to other botulinum toxin products (e.g., Dysport®, Xeomin®, Myobloc®, Jeuveau®, Daxxify®, or Letybo®)
- Have a skin infection at the injection site
About AbbVie
AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines in immunology, oncology, neuroscience, and eye care, along with medical aesthetics through its Allergan Aesthetics division.
The company’s mission is to tackle serious health issues today while advancing tomorrow’s medical innovations
Optimize Your trial insights with Clival Database.
Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.
With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.
To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.
Elevate your trial success rate with the cutting-edge insights from Clival database.
Check it out today and make more informed sourcing decisions! Learn More!
