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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509196-16-00 | EU Trial (CTIS) Number | ||
| 2021-000161-32 | EudraCT Number |
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This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles |
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| Sequence 2 | Other | Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AboBoNT-A | Biological | AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) From Injection to 12 Weeks | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A TEAE was defined for each treatment cycle as any AE that occurred during the cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but the intensity increased during the cycle. Percentage of participants with TEAEs that occurred during each cycle from injection to 12 weeks after injection (until 84 days after injection or until the day prior to next injection day or until end of study/early withdrawal day whichever occurred first) is presented. Percentages are rounded off to the tenth decimal place. | From Baseline (Injection: Day 1) up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs), Treatment-Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) From Injection to 12 Weeks | AE: any untoward medical occurrence in a clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product, or any other medically important event. TEAE for each treatment cycle: any AE that occurred during cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but intensity increased during cycle. ADR: any TEAE that was assessed by Investigator as related to study treatment. AESI: TEAE that suggested a possible remote spread of toxin or events suggestive of hypersensitivity like reactions. |
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Inclusion Criteria:
Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study;
2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study
Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS;
Participants with MAS score of at least 2 at two muscle groups (one of these two muscles groups should be the PTMG) and at least 1 in the remaining muscle group.
Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain);
Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii;
Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate;
Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated are considered by the investigator likely to remain stable for the duration of the study;
Is a woman of non-childbearing potential, defined as postmenopausal for at least
1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy. or
Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the entire study period.A WOCBP must have a negative highly sensitive pregnancy test at screening (urine or serum) as required by local regulations.
Exclusion Criteria:
Major limitations in the passive range of motion in the paretic upper limb;
Major neurological impairment (other than limb paresis) that could negatively affect functional performance;
Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm listed in Section 5.1, or requiring injection into both arms or any lower limb within the timeframe of the study;
Hypersensitivity to any BoNT product or excipients;
Hypersensitivity to cow's milk protein (casein);
Infection at the proposed injection site(s);
Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome);
Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety;
Women who are pregnant or lactating
Participants treated with BoNT of any type for any indication (e.g. bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be treated during the course of the study;
Prior history of non-responsiveness to BoNT treatment;
Previous surgery, or administration of alcohol or phenol in the study limb 6 months or earlier from study enrolment or planned/likely to be treated during the course of the study;
Participants treated with intrathecal baclofen (except if treatment has reached a stable dose for >4 weeks and is likely to remain stable throughout the study), aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) within the 4 weeks prior to study enrolment or planned/likely to be treated during the course of the study
Participants receiving concomitant medication treatment with the following PT/OT interventions on the study limb: new splinting/orthotics/casting, serial casting, shockwave therapy, dry needling and needle tenotomies. However, PT/OT interventions not intended to reduce study limb spasticity (e.g. functional training exercises) or with a transient (<1 day) reduction of study limb spasticity (e.g. stretching, weight bearing) are allowed.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 25233 | United States | ||
| HonorHealth Scottsdale Osborn Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42159955 | Derived | Esquenazi A, Wein TH, Verduzco-Gutierrez M, Ayyoub Z, Page S, Harding S, Maisonobe P, Beneteau M, Patel A; DIRECTION study group. A Phase IV, Randomized, Double-Blind, Crossover Study to Compare the Clinical Safety and Efficacy of AbobotulinumtoxinA and OnabotulinumtoxinA in Adult Upper Limb Spasticity. Adv Ther. 2026 May 20. doi: 10.1007/s12325-026-03635-y. Online ahead of print. | |
| 34562231 |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
A total of 464 participants were randomized in a 1:1 ratio to 1 of the 2 treatment sequences: sequence 1: abobotulinumtoxinA (aboBoNT-A) (Dysport [test]) in Cycle 1 followed by onabotulinumtoxinA (onaBoNT-A) (Botox [reference]) in Cycle 2 and sequence 2: onaBoNT-A in Cycle 1 followed by aboBoNT-A in Cycle 2.
This post-marketing, randomized, double-blind, crossover study was conducted in participants with upper limb spasticity.
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| ID | Title | Description |
|---|---|---|
| FG000 | aboBoNT-A Followed by onaBoNT-A | Participants received aboBoNT-A 900 units (3.6 milliliter [mL]) intramuscular (IM) injection on Day 1 of Cycle 1 followed by onaBoNT-A 360 units (3.6 mL) IM injection in Cycle 2 (at Week 12 [earliest] if retreatment criteria [according to protocol] were fulfilled, or Week 24 of Cycle 1 [latest] until retreatment criteria were fulfilled) in the selected overactive upper limb muscles. Each cycle was 12 to 24 weeks, depending on the time to retreatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 (Day 1 to Weeks 12 or 24) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2025 | Apr 10, 2026 |
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| OnaBoNT-A | Biological | OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL) |
|
|
| From Baseline (Injection: Day 1) up to 12 weeks |
| Adjusted Least Square Mean of Duration of Response Based on Retreatment Criteria | The duration of response was defined for Cycle 1 as time between Cycle 1 injection and the first Cycle 1 visit when retreatment criteria were met (from Week 10 visit), or time between Cycle 1 injection and study withdrawal if the participant discontinued from the study before Cycle 2 injection without meeting retreatment criteria; for Cycle 2 as time between Cycle 2 injection and the first Cycle 2 visit when retreatment criteria were met (from Week 10 visit), or time between Cycle 2 injection and end of study if the participant completed the study or discontinued from the study after Cycle 2 injection without meeting retreatment criteria. It was calculated as the date of retreatment criteria met or withdrawal date (or last visit date for lost to follow-up participants) or completion date - date of injection + 1. | Baseline (Day 1) up to Week 10 (earliest) if retreatment criteria were met, or up to Week 24 (latest) if retreatment criteria were not met |
| Adjusted Least Square Mean of Muscle Tone Assessed by the Modified Ashworth Scale (MAS) for Finger, Wrist and Elbow Flexors Based on Primary Target Muscle Group (PTMG) at Week 12 | Muscle tone for finger, wrist, elbow flexors assessed with MAS tool using scale: 0= no increase in muscle tone, 1= slight increase in muscle tone, manifested by a catch and release or by minimal resistance at end of range of motion (ROM) when affected part(s) was moved in flexion or extension, 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout remainder of ROM, 2= more marked increase in muscle tone through most of ROM, but affected part(s) easily moved, 3= considerable increase in muscle tone, passive movement difficult, 4= affected part(s) rigid in flexion or extension. PTMG included finger, wrist or elbow flexors which were selected by Investigators at screening as muscle group with highest MAS score. MAS total score was calculated as the sum of scores for all 3 joints (finger, wrist, elbow), ranged from: 0 (best) to 12 (worst); higher scores indicated worse outcomes. | Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
| Adjusted Least Square Mean of Perceived Function and Pain Assessed by the Disability Assessment Scale (DAS) Based on Principal Target of Treatment (PTT) at Week 12 | The DAS was used to determine the extent of functional impairment in 4 domains: hygiene, dressing, limb position and pain. Impairment was assessed on a 4-point scale: 0= no disability, 1= mild disability (noticeable but did not interfere significantly with normal activities), 2= moderate disability (normal activities required increased effort and/or assistance) and 3= severe disability (normal activities limited). The 4 domain ratings were added to obtain DAS total score which ranged between 0 (best) and 12 (worst); higher scores indicated severe disability. The PTT was defined at screening as 1 of the 4 domains, with an associated DAS score for assessment. | Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
| Adjusted Least Square Mean of Physician Global Assessment (PGA) of Treatment Response at Week 12 | The PGA of treatment response was assessed by asking the Investigator the following question: 'how would you rate the response to treatment in the participant's upper limb since the last injection?' and answered on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). Higher scores indicate greater better outcomes. 'Any improvement' in PGA was defined by a score including: +1, +2, +3 and +4. | Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
| Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life (QoL) Assessed by the 12-Item Short Form (SF-12) Health Survey Perceived Health Score: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) Scores | SF-12 consisted of 12 questions & asked respondent to answer questions as they pertained to way he/she felt or acted during past week. SF-12 covered 8 domains of health:physical functioning(PF),role physical(RP),bodily pain(BP),general health(GH),vitality(VT),social functioning(SF),role emotional(RE) & mental health(MH). Score range for each of 8 domains:0(maximum disability) to 100(no disability);higher scores:good QoL. Responses on SF-12 were used to obtain 2 summary scores:PCS-12 contributed by PF,RP,BP, and GH and MCS-12 contributed by MH,RE,SF and VT. Summations of item scores of same domains gave sub-scale scores,which were transformed to obtain summary scores of PCS-12 & MCS-12. Both PCS-12 & MCS-12 scores ranged from 0(worst) to 100(best);higher scores:better QoL.Baseline:last non-missing measurement prior to first study treatment administration.Change from baseline in QoL assessed by SF-12 health survey perceived health score based on PCS-12 and MCS-12 scores is presented. | Baseline (Day 1) and Weeks 4, 12, and 24 (end of cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
| Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life Assessed by the Spasticity-Related Quality of Life Tool (SQoL-6D) | The SQoL-6D questionnaire was a brief questionnaire in 6 domains: pain/discomfort, involuntary movements or spasms, restricted range of movement, caring for the affected limb, using the affected limb and mobility/balance which was designed to assess QoL in relation to spasticity that affected the upper limb, which included the arm, shoulder or hand. Each dimension was assessed by asking participants about symptoms within the last 7 days, using a 5-level scale ranging from 0 (best) to 4 (worst); higher scores indicated worse condition. The mean of the 6-dimension scores was calculated to obtain the total score which ranged from 0 (worse) to 100 (best); higher score indicated better QoL. Baseline was defined as the last non-missing measurement prior to first study treatment administration. Change from Baseline in QoL assessed by SQoL-6D is presented. | Baseline (Day 1) and Weeks 4, 12, and 24 (end of Cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Movement Disorders Center of Arizona | Scottsdale | Arizona | 85258 | United States |
| The University of Arizona | Tucson | Arizona | 85724 | United States |
| Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology | Downey | California | 90242 | United States |
| Parkinson's & Movement Disorders Institute | Fountain Valley | California | 92708 | United States |
| Neuro-Pain Medical Center | Fresno | California | 93710 | United States |
| Loma Linda University Health Care | Loma Linda | California | 92350 | United States |
| Southland Neurologic Institute | Long Beach | California | 90808 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Hasbani And Hasbani Medical Group | New Haven | Connecticut | 06511 | United States |
| Ki Health Partners LLC D/B/A New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| First Choice Neurology | Boca Raton | Florida | 33428 | United States |
| James A Haley Veterans Hospital | Tampa | Florida | 33612 | United States |
| University of South Florida Health-Morsani Center for Advanced Healthcare | Tampa | Florida | 33612 | United States |
| Emory University of School of Medicine | Atlanta | Georgia | 30322 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Shirley Ryan Ability Lab | Chicago | Illinois | 60611-3167 | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | United States |
| Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa | Overland Park | Kansas | 66211-1358 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| LSU Healthcare network | New Orleans | Louisiana | 70112 | United States |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| William Beaumont Hospital | Dearborn | Michigan | 48124 | United States |
| Medical Rehabilitation Group, PC | Grand Blanc | Michigan | 48439 | United States |
| Mary Free Bed Rehabilitation Hospital | Grand Rapids | Michigan | 49503 | United States |
| Beaumont Hospital, Grosse Pointe | Grosse Pointe | Michigan | 48230 | United States |
| Michigan Center of Medical Research | Grosse Pointe | Michigan | 48334 | United States |
| Rusk Rehabilitation Center | Columbia | Missouri | 65203-3248 | United States |
| Wr-Crcn, Llc | Las Vegas | Nevada | 89106 | United States |
| Cooper University Health Care | Cherry Hill | New Jersey | 08003 | United States |
| New York University | New York | New York | 10016 | United States |
| Weill Cornell Medicine Clinical and Translational Science Center | New York | New York | 10065 | United States |
| North Suffolk Neurology | Port Jefferson | New York | 11725 | United States |
| Mayo Clinic | Rochester | New York | 55905 | United States |
| Sunnyview Rehabilitation Hospital | Schenectady | New York | 12308 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Cleveland Clinic - Neurological Institute | Cleveland | Ohio | 44195 | United States |
| MossRehab - Einstein Medical Center | Elkins Park | Pennsylvania | 20010 | United States |
| Penn State Health Physical Medicine and Rehabilitation - Neurology | Hershey | Pennsylvania | 17033 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| Aether Medicine | Wayne | Pennsylvania | 19087 | United States |
| Siskin Hospital for Rehabilitation - Neurology | Chattanooga | Tennessee | 37403 | United States |
| The Vanderbilt Clinic | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| TIRR Memorial Hermann Research Center | Houston | Texas | 77030 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| Texas Institute for Neurological Disorders | Sherman | Texas | 75093 | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | United States |
| Carilion Clinic Institute of Orthopaedics and Neurosciences | Roanoke | Virginia | 24016 | United States |
| MedStar National Rehabilitation Network | Columbia | Washington | 20010 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Lawson Health Research Institute | London | Ontario | N6C 5J1 | Canada |
| Moncton Hospital | Moncton | E1C 6Z8 | Canada |
| Genge Partners | Montreal | H3A 2B4 | Canada |
| Victoria General Hospital | Victoria | V9A 3P2 | Canada |
| Centre Les Capucins | Angers | 49100 | France |
| Hôpital Pellegrin CHU Bordeaux | Bordeaux | 33000 | France |
| Hopital Sud | Échirolles | 38434 | France |
| Hôpital d'Instruction des Armées Laveran | Marseille | 13384 | France |
| Hôpital Saint-Jacques (CHU Nantes) | Nantes | 44000 | France |
| Hopital Archet (CHU de Nice) | Nice | 06202 | France |
| Hopital Fernand Widal | Paris | 75010 | France |
| Centre Mutualiste de Rééducation et de Réadaptation Fonction | Ploemeur | France |
| Hôpital Jean Bernard (CHU Poitiers) | Poitiers | 86000 | France |
| Hôpital Pontchaillou (CHU Rennes) | Rennes | 35033 | France |
| Pole Saint Helier | Rennes | 35043 | France |
| Centre de Perharidy | Roscoff | 29680 | France |
| Centre Hospitalier de Saint-Amand-les-Eaux | Saint-Amand-les-Eaux | 59230 | France |
| Centre Hospitalier de Saint Amand Montrond | Saint-Amand-Montrond | 18200 | France |
| Hopital Henry Gabrielle (HCL) | Saint-Genis-Laval | 69230 | France |
| Hopitaux Universitaires De Strasbourg | Strasbourg | 67091 | France |
| Hopital de Rangueil | Toulouse | 31059 | France |
| University of Puerto Rico | Santurce | Puerto Rico | 00912 | Puerto Rico |
| Derived |
| Esquenazi A, Ayyoub Z, Verduzco-Gutierrez M, Maisonobe P, Otto J, Patel AT. AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. Adv Ther. 2021 Nov;38(11):5623-5633. doi: 10.1007/s12325-021-01896-3. Epub 2021 Sep 25. |
| FG001 | onaBoNT-A Followed by aboBoNT-A | Participants received onaBoNT-A 360 units (3.6 mL) IM injection on Day 1 of Cycle 1 followed by aboBoNT-A 900 units (3.6 mL) IM injection in Cycle 2 (at Week 12 [earliest] if retreatment criteria [according to protocol] were fulfilled, or Week 24 of Cycle 1 [latest] until retreatment criteria were fulfilled) in the selected overactive upper limb muscles. Each cycle was 12 to 24 weeks, depending on the time to retreatment. |
| Entered Cycle 1 (Injected) |
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| COMPLETED |
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| NOT COMPLETED |
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| Cycle 2 (Day 1 to Weeks 12 or 24) |
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The randomized set included all participants who were randomized to a treatment sequence.
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| ID | Title | Description |
|---|---|---|
| BG000 | aboBoNT-A Followed by onaBoNT-A | Participants received aboBoNT-A 900 units (3.6 mL) IM injection on Day 1 of Cycle 1 followed by onaBoNT-A 360 units (3.6 mL) IM injection in Cycle 2 (at Week 12 [earliest] if retreatment criteria [according to protocol] were fulfilled, or Week 24 of Cycle 1 [latest] until retreatment criteria were fulfilled) in the selected overactive upper limb muscles. Each cycle was 12 to 24 weeks, depending on the time to retreatment. |
| BG001 | onaBoNT-A Followed by aboBoNT-A | Participants received onaBoNT-A 360 units (3.6 mL) IM injection on Day 1 of Cycle 1 followed by aboBoNT-A 900 units (3.6 mL) IM injection in Cycle 2 (at Week 12 [earliest] if retreatment criteria [according to protocol] were fulfilled, or Week 24 of Cycle 1 [latest] until retreatment criteria were fulfilled) in the selected overactive upper limb muscles. Each cycle was 12 to 24 weeks, depending on the time to retreatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | As pre-specified in the protocol, ethnicity was only captured in the United States of America (USA). Only number of participants evaluable for the specified baseline measure are reported. | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | As pre-specified in the protocol, race was only captured in the USA. Only number of participants evaluable for the specified baseline measure are reported. | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) From Injection to 12 Weeks | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A TEAE was defined for each treatment cycle as any AE that occurred during the cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but the intensity increased during the cycle. Percentage of participants with TEAEs that occurred during each cycle from injection to 12 weeks after injection (until 84 days after injection or until the day prior to next injection day or until end of study/early withdrawal day whichever occurred first) is presented. Percentages are rounded off to the tenth decimal place. | Per protocol set for safety included all participants from safety set who received 1 dose of aboBoNT-A and 1 dose of onaBoNT-A and who completed at least 11 weeks in 12-week period for both cycles without any major protocol deviation that might have interfered with safety evaluation. As pre-specified in statistical analysis plan (SAP), safety results are presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Number | 80% Confidence Interval | percentage of participants | From Baseline (Injection: Day 1) up to 12 weeks |
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| Secondary | Number of Participants With Adverse Drug Reactions (ADRs), Treatment-Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) From Injection to 12 Weeks | AE: any untoward medical occurrence in a clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product, or any other medically important event. TEAE for each treatment cycle: any AE that occurred during cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but intensity increased during cycle. ADR: any TEAE that was assessed by Investigator as related to study treatment. AESI: TEAE that suggested a possible remote spread of toxin or events suggestive of hypersensitivity like reactions. | The safety set included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. As pre-specified in the SAP, safety results are presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Count of Participants | Participants | No | From Baseline (Injection: Day 1) up to 12 weeks |
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| Secondary | Adjusted Least Square Mean of Duration of Response Based on Retreatment Criteria | The duration of response was defined for Cycle 1 as time between Cycle 1 injection and the first Cycle 1 visit when retreatment criteria were met (from Week 10 visit), or time between Cycle 1 injection and study withdrawal if the participant discontinued from the study before Cycle 2 injection without meeting retreatment criteria; for Cycle 2 as time between Cycle 2 injection and the first Cycle 2 visit when retreatment criteria were met (from Week 10 visit), or time between Cycle 2 injection and end of study if the participant completed the study or discontinued from the study after Cycle 2 injection without meeting retreatment criteria. It was calculated as the date of retreatment criteria met or withdrawal date (or last visit date for lost to follow-up participants) or completion date - date of injection + 1. | The full analysis set (FAS) included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. Only those participants with data available at specified timepoints are reported. Data is presented based on planned treatment (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Least Squares Mean | 80% Confidence Interval | days | Baseline (Day 1) up to Week 10 (earliest) if retreatment criteria were met, or up to Week 24 (latest) if retreatment criteria were not met |
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| Secondary | Adjusted Least Square Mean of Muscle Tone Assessed by the Modified Ashworth Scale (MAS) for Finger, Wrist and Elbow Flexors Based on Primary Target Muscle Group (PTMG) at Week 12 | Muscle tone for finger, wrist, elbow flexors assessed with MAS tool using scale: 0= no increase in muscle tone, 1= slight increase in muscle tone, manifested by a catch and release or by minimal resistance at end of range of motion (ROM) when affected part(s) was moved in flexion or extension, 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout remainder of ROM, 2= more marked increase in muscle tone through most of ROM, but affected part(s) easily moved, 3= considerable increase in muscle tone, passive movement difficult, 4= affected part(s) rigid in flexion or extension. PTMG included finger, wrist or elbow flexors which were selected by Investigators at screening as muscle group with highest MAS score. MAS total score was calculated as the sum of scores for all 3 joints (finger, wrist, elbow), ranged from: 0 (best) to 12 (worst); higher scores indicated worse outcomes. | The FAS included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at Week 12 are reported. Data is presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Least Squares Mean | 80% Confidence Interval | score on a scale | Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
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| Secondary | Adjusted Least Square Mean of Perceived Function and Pain Assessed by the Disability Assessment Scale (DAS) Based on Principal Target of Treatment (PTT) at Week 12 | The DAS was used to determine the extent of functional impairment in 4 domains: hygiene, dressing, limb position and pain. Impairment was assessed on a 4-point scale: 0= no disability, 1= mild disability (noticeable but did not interfere significantly with normal activities), 2= moderate disability (normal activities required increased effort and/or assistance) and 3= severe disability (normal activities limited). The 4 domain ratings were added to obtain DAS total score which ranged between 0 (best) and 12 (worst); higher scores indicated severe disability. The PTT was defined at screening as 1 of the 4 domains, with an associated DAS score for assessment. | The FAS included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at Week 12 are reported. Data is presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Least Squares Mean | 80% Confidence Interval | score on a scale | Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
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| Secondary | Adjusted Least Square Mean of Physician Global Assessment (PGA) of Treatment Response at Week 12 | The PGA of treatment response was assessed by asking the Investigator the following question: 'how would you rate the response to treatment in the participant's upper limb since the last injection?' and answered on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). Higher scores indicate greater better outcomes. 'Any improvement' in PGA was defined by a score including: +1, +2, +3 and +4. | The FAS included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at Week 12 are reported. Data is presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Least Squares Mean | 80% Confidence Interval | score on a scale | Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
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| Secondary | Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life (QoL) Assessed by the 12-Item Short Form (SF-12) Health Survey Perceived Health Score: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) Scores | SF-12 consisted of 12 questions & asked respondent to answer questions as they pertained to way he/she felt or acted during past week. SF-12 covered 8 domains of health:physical functioning(PF),role physical(RP),bodily pain(BP),general health(GH),vitality(VT),social functioning(SF),role emotional(RE) & mental health(MH). Score range for each of 8 domains:0(maximum disability) to 100(no disability);higher scores:good QoL. Responses on SF-12 were used to obtain 2 summary scores:PCS-12 contributed by PF,RP,BP, and GH and MCS-12 contributed by MH,RE,SF and VT. Summations of item scores of same domains gave sub-scale scores,which were transformed to obtain summary scores of PCS-12 & MCS-12. Both PCS-12 & MCS-12 scores ranged from 0(worst) to 100(best);higher scores:better QoL.Baseline:last non-missing measurement prior to first study treatment administration.Change from baseline in QoL assessed by SF-12 health survey perceived health score based on PCS-12 and MCS-12 scores is presented. | The FAS included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specific timepoints are reported. Data is presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Weeks 4, 12, and 24 (end of cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
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| Secondary | Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life Assessed by the Spasticity-Related Quality of Life Tool (SQoL-6D) | The SQoL-6D questionnaire was a brief questionnaire in 6 domains: pain/discomfort, involuntary movements or spasms, restricted range of movement, caring for the affected limb, using the affected limb and mobility/balance which was designed to assess QoL in relation to spasticity that affected the upper limb, which included the arm, shoulder or hand. Each dimension was assessed by asking participants about symptoms within the last 7 days, using a 5-level scale ranging from 0 (best) to 4 (worst); higher scores indicated worse condition. The mean of the 6-dimension scores was calculated to obtain the total score which ranged from 0 (worse) to 100 (best); higher score indicated better QoL. Baseline was defined as the last non-missing measurement prior to first study treatment administration. Change from Baseline in QoL assessed by SQoL-6D is presented. | The FAS included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specific timepoints are reported. Data is presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Weeks 4, 12, and 24 (end of Cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks) |
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TEAEs were collected from first dose of study drug (Day 1) up to 24 weeks after injection (Cycles 1 and 2; each cycle was 12 to 24 weeks). All-cause mortality (deaths) was collected from first dose of study drug (Day 1) to the end of follow-up for death for each participant, total follow-up for the study was approximately 217 weeks.
The safety set included all participants from the randomized set who received at least 1 dose of either aboBoNT-A or onaBoNT-A. As pre-specified in the SAP, safety results are presented based on treatment actually received (aboBoNT-A and onaBoNT-A groups overlap and are not mutually exclusive due to crossover design).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | aboBoNT-A | All participants who received at least 1 dose of aboBoNT-A were included in this arm. | 1 | 427 | 21 | 427 | 0 | 427 |
| EG001 | onaBoNT-A | All participants who received at least 1 dose of onaBoNT-A were included in this arm. | 1 | 424 | 20 | 424 | 0 | 424 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Epididymitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Epiglottitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Middle cerebral artery stroke | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Respiratory tract oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Brugada syndrome | Congenital, familial and genetic disorders | MedDRA 28.0 | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | see email | clinical.trials@ipsen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2025 | Apr 10, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| C000629279 | onabotulinum toxin A |
| 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 |
Not provided
Not provided
| Protocol Deviation |
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| Physician Decision |
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| Lost to Follow-up |
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| Death |
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| Other |
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| OG001 | onaBoNT-A | All participants who received at least 1 dose of onaBoNT-A were included in this arm. |
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| onaBoNT-A |
All participants who received at least 1 dose of onaBoNT-A were included in this arm. |
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| OG001 | onaBoNT-A | All participants who received at least 1 dose of onaBoNT-A were included in this arm. |
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All participants who received at least 1 dose of onaBoNT-A were included in this arm. |
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| aboBoNT-A |
All participants who received at least 1 dose of aboBoNT-A were included in this arm. |
| OG001 | onaBoNT-A | All participants who received at least 1 dose of onaBoNT-A were included in this arm. |
|
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| OG001 | onaBoNT-A | All participants who received at least 1 dose of onaBoNT-A were included in this arm. |
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