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Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Active Comparator | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
|
| botulinum toxin Type A Formulation 2 | Active Comparator | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
|
| Placebo (Normal Saline) / botulinum toxin Type A | Other | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. |
|
| Placebo (Normal Saline) / botulinum toxin Type A Formulation 2 | Other | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A | Biological | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winston-Salem | North Carolina | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
| FG001 | Botulinum Toxin Type A Formulation 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| botulinum toxin type A Formulation 2 | Biological | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
|
| Normal Saline | Drug | Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1. |
|
| Week 4 |
| Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'. | Week 4 |
| Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1 | Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement). | Baseline, Week 4 |
| Duration of Treatment Effect for Treatment Responders | Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms). | Up to 6 Months |
| Halifax |
| Nova Scotia |
| Canada |
| Prague | Czechia |
| Berlin | Germany |
| Budapest | Hungary |
| Mumbai | India |
| Manila | Philippines |
| Warsaw | Poland |
| Moscow | Russia |
| Belgrade | Serbia |
| Singapore | Singapore |
| Spisska Nova | Slovakia |
| Cape Town | South Africa |
| Tainan | Taiwan |
| Bangkok | Thailand |
| Bristol | United Kingdom |
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
| FG002 | Placebo (Normal Saline) / Botulinum Toxin Type A | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. |
| FG003 | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
| BG001 | Botulinum Toxin Type A Formulation 2 | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. |
| BG002 | Placebo (Normal Saline) / Botulinum Toxin Type A | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. |
| BG003 | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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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 | Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening. | Intent-To-Treat: All enrolled patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4 |
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| Secondary | Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'. | Intent-to-Treat: All enrolled patients | Posted | Mean | Standard Deviation | Scores on a Scale | Week 4 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'. | Intent-to-Treat: All enrolled patients | Posted | Mean | Standard Deviation | Scores on a Scale | Week 4 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1 | Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement). | Intent-to-Treat: All enrolled patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4 |
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| Secondary | Duration of Treatment Effect for Treatment Responders | Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms). | Intent-to-Treat: All enrolled patients | Posted | Median | 95% Confidence Interval | Days | Up to 6 Months |
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The safety population was used to calculate the number of participants at risk for serious adverse events (SAEs) and adverse events (AEs) and is the total number of patients that were randomized AND treated. SAEs and AEs are presented by randomized arm and not necessarily by treatment received.
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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 | Botulinum Toxin Type A | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. | 9 | 117 | 83 | 117 | ||
| EG001 | Botulinum Toxin Type A Formulation 2 | Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. | 1 | 61 | 41 | 61 | ||
| EG002 | Placebo (Normal Saline) / Botulinum Toxin Type A | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. | 5 | 42 | 31 | 42 | ||
| EG003 | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. | 1 | 21 | 16 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Cholecystitis | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA version 10.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Influenza-like illness | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 10.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 45 and 65 years |
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| >65 years |
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| Male |
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