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The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport® | Experimental | Dysport®, up to 500 units (U)/vial using 2mL dilution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) |
| Measure | Description | Time Frame |
|---|---|---|
| TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Neurology, M.D. | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Movement Disorders Center of Arizona, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32884828 | Derived | Dashtipour K, Wietek S, Rubin B, Maisonobe P, Bahroo L, Trosch R. AbobotulinumtoxinA using 2-mL dilution (500 U/2-mL) maintains durable improvement across multiple treatment cycles. J Clin Mov Disord. 2020 Aug 31;7:8. doi: 10.1186/s40734-020-00090-x. eCollection 2020. |
| Label | URL |
|---|---|
| A-TL-52120-169 | View source |
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Subjects who completed Study 169 and had no on-going Adverse Events (AEs) or whose Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score between Weeks 4 and 8 was reduced by ≤15% from baseline were invited to participate in this OLE study. 112 of the 134 subjects in Study 169 were enrolled into Study 170 (signed informed consent).
This was an open label extension (OLE) study for study A-TL-52120-169 (Study 169). First subject enrolled: 14 March 2013; last subject completed: 13 October 2015. A-TL-52120-170 (Study 170) was conducted in 36 centres in the United States that had participated in Study 169 and enrolled adult subjects with cervical dystonia (CD).
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Dysport® | Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) |
| Treatment Response in Treatment Cycle 3 Week 4. | Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented. | Week 4 Treatment Cycle 3 |
| TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) |
| TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) |
| TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| East Bay Physician's Group | Berkeley | California | 94705 | United States |
| Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| Loma Linda University Healthcare, Department of Neurology | Loma Linda | California | 92354 | United States |
| USC Keck School of Medicine | Los Angeles | California | 90033 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Advanced Neurosciences Research | Fort Collins | Colorado | 80528 | United States |
| Associated Neurologist of Southern CT, PC | Fairfield | Connecticut | 06824 | United States |
| Yale Medical Group, Yale University | New Haven | Connecticut | 06520 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of Florida Center for Movement Disorders and Neurorestoration | Gainesville | Florida | 32607 | United States |
| Emerald Coast Center for Neurological Disorders | Pensacola | Florida | 32514 | United States |
| Parkinson's Treatment Center of SW Florida | Port Charlotte | Florida | 33980 | United States |
| USF HealthParkinson's Disease and Movement Disorders Center | Tampa | Florida | 33613 | United States |
| Guilford Neurologic Associates | West Palm Beach | Florida | 33407 | United States |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Kansas City Bone & Joint Clinic | Kansas City | Kansas | 66211 | United States |
| International Clinical Research Institute | Overland Park | Kansas | 66210 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Rehabilitation Consultants, PA | Eagan | Minnesota | 55121 | United States |
| University of Medicine and Dentistry of New Jersey | Stratford | New Jersey | 08084 | United States |
| Atlantic Neuroscience Institute | Summit | New Jersey | 07901 | United States |
| Kingston Neurological Associates | Kingston | New York | 12401 | United States |
| The Ichan School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Island Neurological Associates | Plainview | New York | 11803 | United States |
| Guilford Neurologic Associates; Cone Health Medical Group | Greensboro | North Carolina | 27405 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio | 45267 | United States |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | United States |
| Penn State Hershey Neurology | Hershey | Pennsylvania | 17033 | United States |
| Coastal Neurology, PA | Port Royal | South Carolina | 29935 | United States |
| North Texas Movement Disorders Institute | Bedford | Texas | 76201 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Puget Sound Neurology | Tacoma | Washington | 98409 | United States |
| Cycle 1 |
|
| Cycle 2 |
|
| Cycle 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Dysport® | Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response in Treatment Cycle 3 Week 4. | Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented. | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. For Treatment Cycle 3 there were 91 evaluable subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 Treatment Cycle 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) |
|
In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks).
Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
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 | Total Dysport® | Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA). | 7 | 112 | 70 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA15.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Myofascial Pain Syndrome | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Sensation of Heaviness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Spinal Deformity | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Burning Sensation | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Head Discomfort | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hyporeflexia | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Movement Disorder | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Tension Headache | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Diverticulum Intestinal | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Gastrointestinal Viral Infection | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Ligament Injury | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Tooth Injury | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Ocular Hyperaemia | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Barium Swallow | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Blood Cholesterol Increased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Blood Testosterone Decreased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Breast Mass | Reproductive system and breast disorders | MedDRA15.0 | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pelvic Fluid Collection | Reproductive system and breast disorders | MedDRA15.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA15.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA15.0 | Systematic Assessment |
| |
| Motion Sickness | Ear and labyrinth disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA15.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA15.0 | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA15.0 | Systematic Assessment |
| |
| Endodontic Procedure | Surgical and medical procedures | MedDRA15.0 | Systematic Assessment |
| |
| Rotator Cuff Repair | Surgical and medical procedures | MedDRA15.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen Biopharmaceuticals, Inc. | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| 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
| Title | Measurements |
|---|---|
|
| 45-54 years |
|
| 55-64 years |
|
| 65-74 years |
|
| +75 years |
|
|
| Mean TWSTRS score at Cycle 1-Week 12/Cycle 2-Day 1 |
|
|
| Mean TWSTRS score at Cycle 2-Week 4 |
|
|
| Mean TWSTRS score at Cycle 2-Week 12/Cycle 3-Day 1 |
|
|
| Mean TWSTRS score at Cycle 3-Week 4 |
|
|
| Mean TWSTRS score at Cycle 3-Week 12 |
|
|
Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.
| Mean Difference (Net) |
| -5.0 |
| Standard Deviation |
| 11.68 |
| 2-Sided |
| 95 |
| -7.36 |
| -2.68 |
| Superiority or Other |
| Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented. | Mean Difference (Net) | -5.9 | Standard Deviation | 7.29 | 2-Sided | 95 | -7.42 | -4.47 | Superiority or Other |
| Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented. | Mean Difference (Net) | -1.8 | Standard Deviation | 7.49 | 2-Sided | 95 | -3.37 | -0.27 | Superiority or Other |
| Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined. | Mean Difference (Net) | -4.1 | Standard Deviation | 9.03 | 2-Sided | 95 | -5.99 | -2.20 | Superiority or Other |
| Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined. | Mean Difference (Net) | -1.1 | Standard Deviation | 9.42 | 2-Sided | 95 | -3.11 | 0.81 | Superiority or Other |
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