Upper Limb Essential Tremor (UL ET)Phase 2NCT05216250

Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

A Phase 2 study testing BOTOX in people with Upper Limb Essential Tremor (UL ET), run by AbbVie at 40 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Upper Limb Essential Tremor (UL ET)
What is being tested?: BOTOX
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 174 participants
Where: 40 sitesin 2 countries
Study dates: 12 Apr 2022to 3 Feb 2025
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.
TREDS-Revised Scale (1-4 scale, whole numbers) unilateral score of >= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb.
TETRAS activities of daily living (ADL) (recorded on a 0-4 scale, whole numbers) minimum score of >= 3 on any of the 5 unilateral items; no more than a single item score of <=1 among the 5 unilateral items in the dominant limb.
At least one of the following criteria must also be met:
TETRAS UL score (0-4 scale, with 0.5 increments) of > 2 in the dominant limb on at least one of the 3 maneuvers OR
TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) of > 2 in the dominant limb

Who cannot join

Any uncontrolled clinically significant medical condition other than the one under study.
Any medical condition that may put the participant at increased risk with exposure to BOTOX Purified Neurotoxin Complex.

Trial locations and contacts

40 sites in 2 countries.

Country

City, postcode or hospital

40 sites in 2 countries

United States36 sites

Dent Neurologic Institute - Amherst /ID# 255665
Amherst, New York, 14226
Emory University / Emory Brain Health Center /ID# 231911
Atlanta, Georgia, 30329-2206
University of Colorado - Anschutz Medical Campus /ID# 239869
Aurora, Colorado, 80045-2527
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677
Boca Raton, Florida, 33486
Tufts Medical Center /ID# 239929
Boston, Massachusetts, 02111-1552
Lahey Hospital & Medical Center /ID# 233232
Burlington, Massachusetts, 01805
Dayton Center for Neurological Disorders /ID# 233737
Centerville, Ohio, 45459-3811
UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857
Chapel Hill, North Carolina, 27517-4400
Medical University of South Carolina /ID# 233538
Charleston, South Carolina, 29425
Texas Neurology /ID# 250428
Dallas, Texas, 75214
University of Texas Southwestern Medical Center /ID# 239770
Dallas, Texas, 75390-7208
Accel Research Site-NeuroStudies /ID# 239881
Decatur, Georgia, 30030-2627
Integrated Neurology Services - Falls Church /ID# 233545
Falls Church, Virginia, 22043-2367
Coastal Clinical Research Specialists /ID# 240897
Fernandina Beach, Florida, 32034-4779
Texas Movement Disorder Specialists, PLLC /ID# 242524
Georgetown, Texas, 78628-4126
Gamma Therapeutic Center /ID# 232547
Greenfield, Wisconsin, 53228-1321
Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472
Hoover, Alabama, 35244-5700
Baylor College of Medicine /ID# 231624
Houston, Texas, 77030
Henry Ford Health Medical Center - Jackson /ID# 231400
Jackson, Michigan, 49201-1852
Coastal Clinical Research Specialists /ID# 240471
Jacksonville, Florida, 32205-8275
Univ Kansas Med Ctr /ID# 231166
Kansas City, Kansas, 66160
Loma Linda University /ID# 230905
Loma Linda, California, 92354
Marshfield Clinic - Marshfield /ID# 233191
Marshfield, Wisconsin, 54449
The Orthopedic Foundation /ID# 232234
New Albany, Ohio, 43054-8167
Charter Research - Winter Park /ID# 241568
Orlando, Florida, 32803-1839
Kansas Institute of Research /ID# 231623
Overland Park, Kansas, 66211-1363
Thomas Jefferson University Hospital /ID# 232614
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731
Phoenix, Arizona, 85013
University of Pittsburgh MC /ID# 233735
Pittsburgh, Pennsylvania, 15260
CDC Research Institute LLC /ID# 242744
Port Saint Lucie, Florida, 34952-7539
Oregon Health and Science University /ID# 231581
Portland, Oregon, 97239
Univ Texas HSC San Antonio /ID# 232615
San Antonio, Texas, 78229-3901
New England Institute for Clinical Research /ID# 238404
Stamford, Connecticut, 06905
University of Arizona /ID# 239781
Tucson, Arizona, 85724
Neurology - Triad /ID# 239806
Winston-Salem, North Carolina, 27103-6984
Atrium Health Wake Forest Baptist Medical Center /ID# 233550
Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Canada4 sites

Centricity Research /ID# 240587
Halifax, Nova Scotia, B3S 1N2
Genge Partners /ID# 251546
Montreal, Quebec, H4A 3T2
Toronto Western Hospital /ID# 231587
Toronto, Ontario, M5T 2S8
Vancouver Coastal Health Authority - University of British Columbia /ID# 240356
Vancouver, British Columbia, V6T 1Z9

Other trials in Canada

About this study

Official title: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor

BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America.

Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions: Upper Limb Essential Tremor (UL ET)
Being tested: BOTOX, Placebo for BOTOX
Keywords: Upper Limb Essential Tremor, UL ET, BOTOX, Botulinum Toxin Type A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOTOXBiological
Also called Botulinum Toxin Type A
Intramuscular injection
Placebo for BOTOXDrug
Intramuscular injection

Study groups in NCT05216250
Study group	Role	What they receive
BOTOX/BOTOX Unilateral	Experimental	Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3 Receives: Biological: BOTOX
BOTOX/BOTOX Bilateral	Experimental	Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3 Receives: Biological: BOTOX
Placebo/BOTOX Unilateral	Experimental	Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3. Receives: Biological: BOTOX; Drug: Placebo for BOTOX
Placebo/BOTOX Bilateral	Experimental	Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3. Receives: Biological: BOTOX; Drug: Placebo for BOTOX

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items
Tremor Disability Scale-Revised (TREDS-R) is a scale to assess activities of daily living (ADL) through a self-questionnaire asking participants to rate how easy or difficult it is to perform a particular activity. The scale consists of 20 items with each item rated on a scale of 1 (able to do the activity without difficulty) to 4 (cannot do the activity by yourself). 7 items included in this subset will be: use a spoon to drink soup, hold a cup of tea, pour milk from a bottle or carton, dial a telephone, pick up your change in a shop, insert an electric plug into a socket, unlock your front door with a key.
Measured: Week 24
Number of Participants with Treatment Emergent Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 36 weeks

Secondary outcomes (6)

Change From Baseline in TETRAS Activity of Daily Living (TETRAS ADL) Total Score Across 5 Unilateral Items
TETRAS Activity of Daily Living (TETRAS ADL) is a clinical rating scale using the total score across 5 unilateral items of the analyzed 10-item TETRAS ADL, with each item's recorded scores of 0 and 1 (0-4 scale) combined into one category with a score of 1 for analysis on a 1-4 scale.
The 5 tasks included in this subset will be feeding with a spoon, drinking from a glass, pouring, using keys, and writing.
Measured: Week 24
Change From Baseline in TETRAS Archimedes Spiral Score
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Archimedes Spiral is an item of the TETRAS performance subscale that is designed to assess tremor severity. During this test, participants are instructed to draw an unbroken spiral which is then scored from 0 to 4, with 1 being tremor is "barely visible" and 4 being "figure not recognizable."
Measured: Week 24
Change From Baseline in TETRAS Handwriting Score
TETRAS Handwriting is an item of the TETRAS performance subscale that is designed to assess tremor severity. During this test, participants are instructed to write the standard sentence "This is a sample of my best handwriting" using the dominant hand only, which is then scored from 0 to 4 with 1 being tremor is "slight: untidy due to tremor that is barely visible" and 4 being "severe: completely illegible."
Measured: Week 24
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
CGI-S is a single item used to measure the clinician's impression of the current severity of the patient's essential tremor. The measure uses a 5-point rating scale where "0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe."
Measured: Week 24
Change From Baseline in Patient Global Impression of Severity (PGI-S)
PGI-S is a single item used to measure the participant's impression of severity of their essential tremor symptoms. The measure uses a 5-point rating scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Measured: Week 24
Change From Baseline in Essential Tremor Rating Assessment (TETRAS UL) Score
TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor during three maneuvers: forward horizontal reach posture, lateral "wing beating" posture, and finger-nose-finger testing. Each maneuver is scored from 0 to 4, with 1 indicating a tremor amplitude that is "barely visible" and 4 indicating a tremor amplitude that is >= 20 cm.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 20223 Feb 2025

First posted31 Jan 2022
Study start12 Apr 2022
Primary completion3 Feb 2025
Study completion3 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Upper Limb Essential Tremor (UL ET)Studies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05216250
Sponsor's protocol ID: M21-471
Other IDs: 2021-002191-39
Status last verified: Jan 2026
First submitted: 1 Oct 2021
Last updated: 20 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.