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At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Experimental | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection |
|
| incobotulinumtoxinA (Xeomin) (120 Units) | Experimental | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection |
|
| Placebo | Placebo Comparator | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Drug | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Baseline, week 4 |
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Baseline, week 4 |
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the TWSTRS-Total Score | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Comella, M.D. | Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21764407 | Result | Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-9. doi: 10.1016/j.jns.2011.05.041. Epub 2011 Jul 18. | |
| 23779062 |
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| ID | Title | Description |
|---|---|---|
| FG000 | incobotulinumtoxinA (Xeomin) (240 Units) | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection |
| FG001 | incobotulinumtoxinA (Xeomin) (120 Units) | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection |
| FG002 | Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Period - 8 to 20 Weeks |
|
| |||||||||||||||||||||
| Extension Period - up to 68 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | incobotulinumtoxinA (Xeomin) (240 Units) | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Least Squares Mean | Standard Error | points on a scale | Baseline, week 4 |
|
All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | incobotulinumtoxinA (Xeomin) (240 Units) | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelika Hanschmann | Merz Pharmaceuticals GmbH | ++49-69-1503 | 538 | angelika.hanschmann@merz.de |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| incobotulinumtoxinA (Xeomin) (120 Units) | Drug | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units) |
|
| Placebo | Drug | Placebo |
|
| Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period) |
| Change From Baseline in the TWSTRS Disability Subscore | TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) |
| Change From Baseline in the TWSTRS Severity Subscore | TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) |
| Change From Baseline in the TWSTRS Pain Subscore | TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) |
| Patient Evaluation of Global Response (PEGR) at Final Visit | The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4). | Final visit (up to 20 weeks after injection of the Main Period) |
| Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19. |
| Lost to Follow-up |
|
| Consent Withdrawn |
|
| Withdrawal Criteria Occurred |
|
| Patient Decision |
|
|
| NOT COMPLETED |
|
|
| BG001 |
| incobotulinumtoxinA (Xeomin) (120 Units) |
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection |
| BG002 | Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| incobotulinumtoxinA (Xeomin) (240 Units) |
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection |
| OG001 | Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection |
|
|
|
| Secondary | Change From Baseline in the TWSTRS-Total Score | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Mean | Standard Deviation | points on a scale | Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period) |
|
|
|
| Secondary | Change From Baseline in the TWSTRS Disability Subscore | TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Mean | Standard Deviation | points on a scale | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) |
|
|
|
| Secondary | Change From Baseline in the TWSTRS Severity Subscore | TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Mean | Standard Deviation | points on a scale | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) |
|
|
|
| Secondary | Change From Baseline in the TWSTRS Pain Subscore | TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Mean | Standard Deviation | points on a scale | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) |
|
|
|
| Secondary | Patient Evaluation of Global Response (PEGR) at Final Visit | The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4). | Intention to treat population with missing values imputed by "no effect" | Posted | Mean | Standard Deviation | points on a scale | Final visit (up to 20 weeks after injection of the Main Period) |
|
|
|
| Primary | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Least Squares Mean | Standard Error | points on a scale | Baseline, week 4 |
|
|
|
|
| Primary | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | The TWSTRS-Total score is the sum of scores of the three components of the scale:
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. | Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value | Posted | Least Squares Mean | Standard Error | points on a scale | Baseline, week 4 |
|
|
|
|
| 4 |
| 81 |
| 27 |
| 81 |
| EG001 | incobotulinumtoxinA (Xeomin) (120 Units) | incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection | 0 | 78 | 26 | 78 |
| EG002 | Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection | 0 | 74 | 14 | 74 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Musculosceletal pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 weeks before submission. Sponsor to give written opinion within 30 days. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
|
| Baseline - Final Visit |
|
|
| Baseline - Final Visit |
|
|
| Baseline - Final Visit |
|
| No |
| Superiority or Other |
| No |
| Superiority or Other |