Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001650-94 | EudraCT Number |
Not provided
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Strategic business decision was made to terminate the program. There were no safety concerns.
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This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of OnabotulinumtoxinA for the treatment of male participants with PE. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA Dose 1 | Experimental | OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. |
|
| OnabotulinumtoxinA Dose 2 | Experimental | OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. |
|
| OnabotulinumtoxinA Dose 3 | Experimental | OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. |
|
| OnabotulinumtoxinA Dose 4 | Experimental | OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. |
|
| OnabotulinumtoxinA Dose 5 | Experimental | OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. |
|
| OnabotulinumtoxinA Dose 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | OnabotulinumtoxinA injected into specified muscle per protocol on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. | Baseline (Day 1) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average IELT | IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Radecki | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Sexual Medicine | San Diego | California | 92120 | United States | ||
| LA Biomedical Research Institute at Harbor-UCLA Medical Center |
Not provided
| Label | URL |
|---|---|
| More Information | View source |
Not provided
Participants received a single treatment of either placebo or OnabotulinumtoxinA (Doses 1, 2, 3, 4, 5, 6), delivered bilaterally to the bulbospongiosus muscle in randomized-treatment period. Participants who completed 12 weeks of randomized period were eligible to receive second injection with OnabotulinumtoxinA Dose 2 in Open-label Period.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA Dose 1 | OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. |
| FG001 | OnabotulinumtoxinA Dose 2 | OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. |
| FG002 | OnabotulinumtoxinA Dose 3 | OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. |
| FG003 | OnabotulinumtoxinA Dose 4 | OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. |
| FG004 | OnabotulinumtoxinA Dose 5 | OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. |
| FG005 | OnabotulinumtoxinA Dose 6 | OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. |
| FG006 | Placebo | Placebo (normal saline) injected into specified muscle per protocol on Day 1. |
| FG007 | OnabotulinumtoxinA Dose 2 (Open-label Period) | Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized-treatment Period |
|
| ||||||||||||||||||
| Open-label Period |
|
The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OnabotulinumtoxinA Dose 1 | OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. |
| BG001 | OnabotulinumtoxinA Dose 2 | OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. |
| 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 Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. | The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point. | Posted | Mean | Standard Deviation | log(seconds) | Baseline (Day 1) to Week 12 |
|
First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment.
Safety Population included all treated participants.
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 | OnabotulinumtoxinA Dose 1 | OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA, Version 20.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2016 | Aug 15, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2016 | Aug 15, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
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Not provided
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. |
|
| Placebo | Placebo Comparator | Placebo (normal saline) injected into specified muscle per protocol on Day 1. |
|
|
| Normal Saline | Drug | Placebo (normal saline) injected into specified muscle per protocol on Day 1. |
|
| Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12 |
| Change From Baseline in Geometric Mean IELT | IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. | Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10 |
| Torrance |
| California |
| 90502 |
| United States |
| Connecticut Clinical Research Center | Middlebury | Connecticut | 06762 | United States |
| Center for Marital and Sexual Health of South Florida | West Palm Beach | Florida | 33401 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Celerion | Belfast | BT9 6AD | United Kingdom |
| King's College Hospital | London | SE5 9RJ | United Kingdom |
| Queen Anne Street Medical Center | London | W1G 8HU | United Kingdom |
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| Personal Reasons |
|
| Protocol Violation |
|
| Other Miscellaneous Reasons |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | OnabotulinumtoxinA Dose 3 | OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. |
| BG003 | OnabotulinumtoxinA Dose 4 | OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. |
| BG004 | OnabotulinumtoxinA Dose 5 | OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. |
| BG005 | OnabotulinumtoxinA Dose 6 | OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. |
| BG006 | Placebo | Placebo (normal saline) injected into specified muscle per protocol on Day 1. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG000 | OnabotulinumtoxinA Dose 1 | OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. |
| OG001 | OnabotulinumtoxinA Dose 2 | OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. |
| OG002 | OnabotulinumtoxinA Dose 3 | OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. |
| OG003 | OnabotulinumtoxinA Dose 4 | OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. |
| OG004 | OnabotulinumtoxinA Dose 5 | OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. |
| OG005 | OnabotulinumtoxinA Dose 6 | OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. |
| OG006 | Placebo | Placebo (normal saline) injected into specified muscle per protocol on Day 1. |
|
|
|
| Secondary | Change From Baseline in Average IELT | IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. | The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participants. Number analyzed is the number of participants with available data at the given time-point. | Posted | Mean | Standard Deviation | seconds | Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Geometric Mean IELT | IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. | The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point. | Posted | Mean | Standard Deviation | log(seconds) | Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10 |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | OnabotulinumtoxinA Dose 2 | OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | OnabotulinumtoxinA Dose 3 | OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | OnabotulinumtoxinA Dose 4 | OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG004 | OnabotulinumtoxinA Dose 5 | OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG005 | OnabotulinumtoxinA Dose 6 | OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG006 | Placebo | Placebo (normal saline) injected into specified muscle per protocol on Day 1. | 0 | 15 | 0 | 15 | 12 | 15 |
| EG007 | OnabotulinumtoxinA Dose 2 (Open-label Period) | Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period. | 0 | 8 | 0 | 8 | 3 | 8 |
| Vision blurred | Eye disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA, Version 20.0 | Systematic Assessment |
|
| Penis injury | Injury, poisoning and procedural complications | MedDRA, Version 20.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA, Version 20.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA, Version 20.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA, Version 20.0 | Systematic Assessment |
|
| Semen volume decreased | Investigations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA, Version 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Enuresis | Psychiatric disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Psychogenic erectile dysfunction | Psychiatric disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Terminal dribbling | Renal and urinary disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Epididymal tenderness | Reproductive system and breast disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Ejaculation failure | Reproductive system and breast disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Hypogonadism | Endocrine disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA, Version 20.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA, Version 20.0 | Systematic Assessment |
|
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.
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| 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 |
|
|
| Change from Baseline to Week 2 |
|
|
| Change from Baseline to Week 4 |
|
|
| Change from Baseline to Week 6 |
|
|
| Change from Baseline to Week 8 |
|
|
| Change from Baseline to Week 10 |
|
|
| Change from Baseline to Week 12 |
|
|
OnabotulinumtoxinA Dose 2 vs Placebo at Week 2 |
| ANCOVA |
| 0.002 |
Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. |
| Least square mean difference |
| 170.21 |
| Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 2 | ANCOVA | 0.404 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 12.73 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 2 | ANCOVA | 0.328 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 24.23 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 2 | ANCOVA | 0.362 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 18.48 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 2 | ANCOVA | 0.203 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 45.42 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 4 | ANCOVA | 0.322 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 33.05 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 4 | ANCOVA | 0.015 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 148.86 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 4 | ANCOVA | 0.541 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -6.20 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 4 | ANCOVA | 0.459 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 6.47 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 4 | ANCOVA | 0.491 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 1.32 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 4 | ANCOVA | 0.281 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 36.80 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 6 | ANCOVA | 0.424 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 14.12 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 6 | ANCOVA | 0.026 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 136.96 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 6 | ANCOVA | 0.670 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -27.62 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 6 | ANCOVA | 0.561 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -10.06 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 6 | ANCOVA | 0.604 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -16.58 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 6 | ANCOVA | 0.394 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 17.76 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 8 | ANCOVA | 0.532 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -5.94 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 8 | ANCOVA | 0.058 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 111.27 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 8 | ANCOVA | 0.778 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -48.65 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 8 | ANCOVA | 0.662 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -27.74 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 8 | ANCOVA | 0.712 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -35.72 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 8 | ANCOVA | 0.501 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -0.18 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 10 | ANCOVA | 0.565 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -12.14 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 10 | ANCOVA | 0.071 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 102.44 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 10 | ANCOVA | 0.799 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -52.81 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 10 | ANCOVA | 0.681 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -30.81 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 10 | ANCOVA | 0.741 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -40.68 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 10 | ANCOVA | 0.526 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -4.33 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 12 | ANCOVA | 0.584 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -14.76 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 12 | ANCOVA | 0.101 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | 84.09 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 12 | ANCOVA | 0.823 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -55.14 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 12 | ANCOVA | 0.741 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -40.18 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 12 | ANCOVA | 0.756 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -41.31 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 12 | ANCOVA | 0.517 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate. | Least square mean difference | -2.57 | Superiority |
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| Change from Baseline to Week 2 |
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| Change from Baseline to Week 4 |
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| Change from Baseline to Week 6 |
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 10 |
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OnabotulinumtoxinA Dose 2 vs Placebo at Week 2 |
| ANCOVA |
| 0.025 |
Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. |
| Least square mean difference |
| 0.77 |
| Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 2 | ANCOVA | 0.417 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.07 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 2 | ANCOVA | 0.330 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.16 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 2 | ANCOVA | 0.199 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.30 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 2 | ANCOVA | 0.113 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.45 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 4 | ANCOVA | 0.127 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.50 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 4 | ANCOVA | 0.087 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.56 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 4 | ANCOVA | 0.543 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.04 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 4 | ANCOVA | 0.377 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.12 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 4 | ANCOVA | 0.321 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.17 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 4 | ANCOVA | 0.149 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.40 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 6 | ANCOVA | 0.215 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.35 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 6 | ANCOVA | 0.126 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.47 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 6 | ANCOVA | 0.774 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.28 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 6 | ANCOVA | 0.495 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.01 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 6 | ANCOVA | 0.495 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.00 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 6 | ANCOVA | 0.274 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.23 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 8 | ANCOVA | 0.308 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.22 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 8 | ANCOVA | 0.205 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.34 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 8 | ANCOVA | 0.849 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.39 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 8 | ANCOVA | 0.571 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.07 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 8 | ANCOVA | 0.592 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.09 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 8 | ANCOVA | 0.340 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.16 | Superiority |
| OnabotulinumtoxinA Dose 1 vs Placebo at Week 10 | ANCOVA | 0.360 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.16 | Superiority |
| OnabotulinumtoxinA Dose 2 vs Placebo at Week 10 | ANCOVA | 0.192 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.35 | Superiority |
| OnabotulinumtoxinA Dose 3 vs Placebo at Week 10 | ANCOVA | 0.843 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.37 | Superiority |
| OnabotulinumtoxinA Dose 4 vs Placebo at Week 10 | ANCOVA | 0.572 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.07 | Superiority |
| OnabotulinumtoxinA Dose 5 vs Placebo at Week 10 | ANCOVA | 0.628 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | -0.12 | Superiority |
| OnabotulinumtoxinA Dose 6 vs Placebo at Week 10 | ANCOVA | 0.380 | Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate. | Least square mean difference | 0.12 | Superiority |