Back to resultsStudy of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
Primary Purpose
Upper Limb Essential Tremor (UL ET)
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BOTOX
Placebo for BOTOX
Sponsored by
About this trial
This is an interventional treatment trial for Upper Limb Essential Tremor (UL ET) focused on measuring Upper Limb Essential Tremor, UL ET, BOTOX, Botulinum Toxin Type A
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.
- The Essential Tremor Rating Assessment Scale (TETRAS) upper limit (UL) score (0-4 scale, with 0.5 increments) of > 2 in the dominant limb on at least one of the 3 maneuvers.
- TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) > 2 in the dominant limb.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472Recruiting
- Barrow Neurological Institute /ID# 231731Recruiting
- University of Arizona /ID# 239781Recruiting
- Loma Linda University /ID# 230905Recruiting
- University of Colorado - Anschutz Medical Campus /ID# 239869Recruiting
- Ki Health Partners, LLC, dba, New England Institute for Clinical Research /ID# 238404Recruiting
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677Recruiting
- Coastal Clinical Research Specialists /ID# 240897Recruiting
- Coastal Clinical Research Specialists /ID# 240471Recruiting
- CDC Research Institute LLC /ID# 242744
- Charter Research - Winter Park /ID# 241568Recruiting
- Emory University / Emory Brain Health Center /ID# 231911Recruiting
- Accel Research Site-NeuroStudies /ID# 239881Recruiting
- Univ Kansas Med Ctr /ID# 231166Recruiting
- Kansas Institute of Research /ID# 231623Recruiting
- Tufts Medical Center /ID# 239929Recruiting
- Lahey Hospital and Medical Center /ID# 233232Recruiting
- Henry Ford Health Medical Center - Jackson /ID# 231400
- UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857Recruiting
- Neurology - Triad /ID# 239806Recruiting
- Wake Forest Baptist Medical Center /ID# 233550Recruiting
- Dayton Center for Neurological Disorders /ID# 233737Recruiting
- The Orthopedic Foundation /ID# 232234Recruiting
- Oregon Health & Science University /ID# 231581Recruiting
- Thomas Jefferson University /ID# 232614Recruiting
- University of Pittsburgh MC /ID# 233735Recruiting
- Medical University of South Carolina /ID# 233538Recruiting
- Texas Neurology /ID# 250428Recruiting
- University of Texas Southwestern Medical Center /ID# 239770Recruiting
- Texas Movement Disorder Specialists, PLLC /ID# 242524Recruiting
- Baylor College of Medicine - Baylor Medical Center /ID# 231624Recruiting
- Univ Texas HSC San Antonio /ID# 232615Recruiting
- Integrated Neurology Services - Falls Church /ID# 233545Recruiting
- Gamma Therapeutic Center /ID# 232547Recruiting
- Marshfield Clinic - Marshfield /ID# 233191Recruiting
- Vancouver Coastal Health Authority - University of British Columbia /ID# 240356Recruiting
- Centricity Research /ID# 240587Recruiting
- Toronto Western Hospital /ID# 231587Recruiting
- Genge Partners /ID# 251546Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
BOTOX/BOTOX Unilateral
BOTOX/BOTOX Bilateral
Placebo/BOTOX Unilateral
Placebo/BOTOX Bilateral
Arm Description
Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3
Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3
Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3.
Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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."
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."
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."
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05216250
Brief Title
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
February 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Essential Tremor (UL ET)
Keywords
Upper Limb Essential Tremor, UL ET, BOTOX, Botulinum Toxin Type A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BOTOX/BOTOX Unilateral
Arm Type
Experimental
Arm Description
Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3
Arm Title
BOTOX/BOTOX Bilateral
Arm Type
Experimental
Arm Description
Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3
Arm Title
Placebo/BOTOX Unilateral
Arm Type
Experimental
Arm Description
Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3.
Arm Title
Placebo/BOTOX Bilateral
Arm Type
Experimental
Arm Description
Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3.
Intervention Type
Biological
Intervention Name(s)
BOTOX
Other Intervention Name(s)
Botulinum Toxin Type A
Intervention Description
Intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo for BOTOX
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in TETRAS Activity of Daily Living (TETRAS ADL) Total Score Across 5 Unilateral Items
Description
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.
Time Frame
Week 24
Title
Change From Baseline in TETRAS Archimedes Spiral Score
Description
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."
Time Frame
Week 24
Title
Change From Baseline in TETRAS Handwriting Score
Description
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."
Time Frame
Week 24
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
Description
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."
Time Frame
Week 24
Title
Change From Baseline in Patient Global Impression of Severity (PGI-S)
Description
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.
Time Frame
Week 24
Title
Change From Baseline in Essential Tremor Rating Assessment (TETRAS UL) Score
Description
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.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244-5700
Country
United States
Individual Site Status
Recruiting
Facility Name
Barrow Neurological Institute /ID# 231731
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4407
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arizona /ID# 239781
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
Loma Linda University /ID# 230905
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado - Anschutz Medical Campus /ID# 239869
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2527
Country
United States
Individual Site Status
Recruiting
Facility Name
Ki Health Partners, LLC, dba, New England Institute for Clinical Research /ID# 238404
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Clinical Research Specialists /ID# 240897
City
Fernandina Beach
State/Province
Florida
ZIP/Postal Code
32034-4779
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Clinical Research Specialists /ID# 240471
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205-8275
Country
United States
Individual Site Status
Recruiting
Facility Name
CDC Research Institute LLC /ID# 242744
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952-7539
Country
United States
Individual Site Status
Completed
Facility Name
Charter Research - Winter Park /ID# 241568
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792-6707
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University / Emory Brain Health Center /ID# 231911
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329-2206
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Site-NeuroStudies /ID# 239881
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030-2627
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ Kansas Med Ctr /ID# 231166
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas Institute of Research /ID# 231623
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1363
Country
United States
Individual Site Status
Recruiting
Facility Name
Tufts Medical Center /ID# 239929
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Individual Site Status
Recruiting
Facility Name
Lahey Hospital and Medical Center /ID# 233232
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health Medical Center - Jackson /ID# 231400
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201-1852
Country
United States
Individual Site Status
Completed
Facility Name
UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517-4400
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology - Triad /ID# 239806
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-6984
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Medical Center /ID# 233550
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Individual Site Status
Recruiting
Facility Name
Dayton Center for Neurological Disorders /ID# 233737
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459-3811
Country
United States
Individual Site Status
Recruiting
Facility Name
The Orthopedic Foundation /ID# 232234
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054-8167
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University /ID# 231581
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University /ID# 232614
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh MC /ID# 233735
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina /ID# 233538
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Texas Neurology /ID# 250428
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center /ID# 239770
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Movement Disorder Specialists, PLLC /ID# 242524
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628-4126
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 231624
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ Texas HSC San Antonio /ID# 232615
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3901
Country
United States
Individual Site Status
Recruiting
Facility Name
Integrated Neurology Services - Falls Church /ID# 233545
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22043-2367
Country
United States
Individual Site Status
Recruiting
Facility Name
Gamma Therapeutic Center /ID# 232547
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228-1321
Country
United States
Individual Site Status
Recruiting
Facility Name
Marshfield Clinic - Marshfield /ID# 233191
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Name
Vancouver Coastal Health Authority - University of British Columbia /ID# 240356
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research /ID# 240587
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Western Hospital /ID# 231587
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Genge Partners /ID# 251546
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M21-471
Description
Related Info
Learn more about this trial
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
We'll reach out to this number within 24 hrs