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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002191-39 | EudraCT Number |
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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. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX/BOTOX Unilateral | Experimental | Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3 |
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| BOTOX/BOTOX Bilateral | Experimental | Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3 |
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| Placebo/BOTOX Unilateral | Experimental | Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3. |
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| Placebo/BOTOX Bilateral | Experimental | Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472 | Hoover | Alabama | 35244-5700 | United States | ||
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.
For details on when studies are available for sharing, please refer to the link below.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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| Placebo for BOTOX | Drug | Intramuscular injection |
|
| 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." | 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." | 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." | 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. | 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. | Week 24 |
| Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| University of Arizona /ID# 239781 | Tucson | Arizona | 85724 | United States |
| Loma Linda University /ID# 230905 | Loma Linda | California | 92354 | United States |
| University of Colorado - Anschutz Medical Campus /ID# 239869 | Aurora | Colorado | 80045-2527 | United States |
| New England Institute for Clinical Research /ID# 238404 | Stamford | Connecticut | 06905 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677 | Boca Raton | Florida | 33486 | United States |
| Coastal Clinical Research Specialists /ID# 240897 | Fernandina Beach | Florida | 32034-4779 | United States |
| Coastal Clinical Research Specialists /ID# 240471 | Jacksonville | Florida | 32205-8275 | United States |
| Charter Research - Winter Park /ID# 241568 | Orlando | Florida | 32803-1839 | United States |
| CDC Research Institute LLC /ID# 242744 | Port Saint Lucie | Florida | 34952-7539 | United States |
| Emory University / Emory Brain Health Center /ID# 231911 | Atlanta | Georgia | 30329-2206 | United States |
| Accel Research Site-NeuroStudies /ID# 239881 | Decatur | Georgia | 30030-2627 | United States |
| Univ Kansas Med Ctr /ID# 231166 | Kansas City | Kansas | 66160 | United States |
| Kansas Institute of Research /ID# 231623 | Overland Park | Kansas | 66211-1363 | United States |
| Tufts Medical Center /ID# 239929 | Boston | Massachusetts | 02111-1552 | United States |
| Lahey Hospital & Medical Center /ID# 233232 | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Health Medical Center - Jackson /ID# 231400 | Jackson | Michigan | 49201-1852 | United States |
| Dent Neurologic Institute - Amherst /ID# 255665 | Amherst | New York | 14226 | United States |
| UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857 | Chapel Hill | North Carolina | 27517-4400 | United States |
| Neurology - Triad /ID# 239806 | Winston-Salem | North Carolina | 27103-6984 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 233550 | Winston-Salem | North Carolina | 27157-0001 | United States |
| Dayton Center for Neurological Disorders /ID# 233737 | Centerville | Ohio | 45459-3811 | United States |
| The Orthopedic Foundation /ID# 232234 | New Albany | Ohio | 43054-8167 | United States |
| Oregon Health and Science University /ID# 231581 | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University Hospital /ID# 232614 | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh MC /ID# 233735 | Pittsburgh | Pennsylvania | 15260 | United States |
| Medical University of South Carolina /ID# 233538 | Charleston | South Carolina | 29425 | United States |
| Texas Neurology /ID# 250428 | Dallas | Texas | 75214 | United States |
| University of Texas Southwestern Medical Center /ID# 239770 | Dallas | Texas | 75390-7208 | United States |
| Texas Movement Disorder Specialists, PLLC /ID# 242524 | Georgetown | Texas | 78628-4126 | United States |
| Baylor College of Medicine /ID# 231624 | Houston | Texas | 77030 | United States |
| Univ Texas HSC San Antonio /ID# 232615 | San Antonio | Texas | 78229-3901 | United States |
| Integrated Neurology Services - Falls Church /ID# 233545 | Falls Church | Virginia | 22043-2367 | United States |
| Gamma Therapeutic Center /ID# 232547 | Greenfield | Wisconsin | 53228-1321 | United States |
| Marshfield Clinic - Marshfield /ID# 233191 | Marshfield | Wisconsin | 54449 | United States |
| Vancouver Coastal Health Authority - University of British Columbia /ID# 240356 | Vancouver | British Columbia | V6T 1Z9 | Canada |
| Centricity Research /ID# 240587 | Halifax | Nova Scotia | B3S 1N2 | Canada |
| Toronto Western Hospital /ID# 231587 | Toronto | Ontario | M5T 2S8 | Canada |
| Genge Partners /ID# 251546 | Montreal | Quebec | H4A 3T2 | Canada |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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