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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000802-14 | EudraCT Number |
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Study aimed at comparing the pharmacodynamic profile (including duration of action) of three commercialized toxins by measuring the action potential of the injected muscle (extensor digitorum brevis)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport® | Experimental | 40 Units (U) Intramuscular (IM) injection at day 1. |
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| Botox® | Active Comparator | 16U IM at day 1. |
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| Xeomin® | Active Comparator | 16U IM at day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | Intramuscular Injection, concentration 300 units (U) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28 | The CMAP procedure was performed on the injected foot by a neurophysiologist. Percentage relative to baseline was calculated as (value at Week 28 [mean of the 3 measurements]/baseline value) multiplied by (*) 100. The adjusted mean was obtained from a mixed-effects model for repeated measures (MMRM) model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline. | Baseline (Day 1) and Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AM % of CMAP Total Amplitude at Week 40 | The CMAP procedure was performed on the injected foot by a neurophysiologist. It was measured as percentage relative to baseline defined as CMAP at the corresponding visit (mean of the 3 measurements)/CMAP at baseline (mean of the 6 measurements)*100. The adjusted mean was obtained from a MMRM model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mac Research Clinical research Unit | Manchester | United Kingdom |
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This study consisted of a 14-day screening period, a double-blind period including treatment administration on Day 1, and follow-up period up to 40 weeks. A total of 45 male participants were randomized in a 1:1:1 ratio to receive treatment with Dysport 40 U, Botox 16 U or Xeomin 16 U respectively.
This Phase I, randomized, double-blind study was conducted in healthy adult male participants at a single investigational site in United Kingdom between 06 Jul 2021 and 08 Jun 2022. The purpose of this study was to compare the duration of action on compound muscle action potential (CMAP) of the extensor digitorum brevis (EDB) muscle injected with either Dysport 40 units (U), Botox 16 U or Xeomin 16 U.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport 40 U | Participants received a single intramuscular (IM) injection of Dysport 40 U in the EDB muscle on Day 1. |
| FG001 | Botox 16 U | Participants received a single IM injection of Botox 16 U in the EDB muscle on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2021 | Apr 28, 2023 |
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| Botulinum toxin type A | Biological | Intramuscular Injection, concentration 50 U |
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| Botulinum toxin type A | Biological | Intramuscular Injection, concentration 50 U |
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| Baseline (Day 1) and Week 40 |
| Percentage of Participants With Recovery of CMAP Total Amplitude | The recovery was considered to be reached for all the visits occurring after the time to recovery, that is (i.e.) the first visit for which CMAP total amplitude returned to at least 85% of the baseline value. Percentage of participants with recovery of CMAP total amplitude was analyzed at Weeks 28 and 40. | At Weeks 28 and 40 |
| Time to Onset of Action of Study Intervention | Time to onset of action was defined as the first timepoint when EDB CMAP total amplitude was less or equal to 85% of the baseline value. | From Baseline (Day 1) up to Week 40 |
| Duration of Response | Duration of response was calculated as time to recovery of CMAP total amplitude - time to onset. Time to recovery was defined as the first timepoint where EDB CMAP total amplitude returned to at least 85% of the baseline value. | From Baseline (Day 1) up to Week 40 |
| Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude | Maximal inhibition was defined as the maximal measured inhibition of CMAP total amplitude of stimulated EDB. | Up to Week 40 |
| Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude | Time to maximal effect was defined on an individual basis as the time between baseline and the timepoint of maximal inhibition of CMAP amplitude of stimulated EDB. Participants with maximal effect of CMAP total amplitude were reported. | At Weeks 1, 4, 8 and 20 |
| FG002 | Xeomin 16 U | Participants received a single IM injection of Xeomin 16 U in the EDB muscle on Day 1. |
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The Randomized set consisted of all participants who were randomized to study treatment. A participant was considered as randomized if a study intervention group was randomly assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dysport 40 U | Participants received a single IM injection of Dysport 40 U in the EDB muscle on Day 1. |
| BG001 | Botox 16 U | Participants received a single IM injection of Botox 16 U in the EDB muscle on Day 1. |
| BG002 | Xeomin 16 U | Participants received a single IM injection of Xeomin 16 U in the EDB muscle on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28 | The CMAP procedure was performed on the injected foot by a neurophysiologist. Percentage relative to baseline was calculated as (value at Week 28 [mean of the 3 measurements]/baseline value) multiplied by (*) 100. The adjusted mean was obtained from a mixed-effects model for repeated measures (MMRM) model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline. | The Pharmacodynamic (PD) analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. | Posted | Mean | Standard Error | % of AM of CMAP total amplitude | Baseline (Day 1) and Week 28 |
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| Secondary | Change From Baseline in AM % of CMAP Total Amplitude at Week 40 | The CMAP procedure was performed on the injected foot by a neurophysiologist. It was measured as percentage relative to baseline defined as CMAP at the corresponding visit (mean of the 3 measurements)/CMAP at baseline (mean of the 6 measurements)*100. The adjusted mean was obtained from a MMRM model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline. | The PD analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. | Posted | Mean | Standard Error | % of AM of CMAP total amplitude | Baseline (Day 1) and Week 40 |
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| Secondary | Percentage of Participants With Recovery of CMAP Total Amplitude | The recovery was considered to be reached for all the visits occurring after the time to recovery, that is (i.e.) the first visit for which CMAP total amplitude returned to at least 85% of the baseline value. Percentage of participants with recovery of CMAP total amplitude was analyzed at Weeks 28 and 40. | The PD analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. Only those participants who showed recovery at Weeks 28 and 40 were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 28 and 40 |
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| Secondary | Time to Onset of Action of Study Intervention | Time to onset of action was defined as the first timepoint when EDB CMAP total amplitude was less or equal to 85% of the baseline value. | The PD analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. | Posted | Median | Full Range | weeks | From Baseline (Day 1) up to Week 40 |
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| Secondary | Duration of Response | Duration of response was calculated as time to recovery of CMAP total amplitude - time to onset. Time to recovery was defined as the first timepoint where EDB CMAP total amplitude returned to at least 85% of the baseline value. | The PD analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. Only those participants who showed recovery before the end of the study were analyzed. | Posted | Median | Full Range | weeks | From Baseline (Day 1) up to Week 40 |
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| Secondary | Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude | Maximal inhibition was defined as the maximal measured inhibition of CMAP total amplitude of stimulated EDB. | The PD analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. | Posted | Mean | 95% Confidence Interval | percentage of inhibition | Up to Week 40 |
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| Secondary | Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude | Time to maximal effect was defined on an individual basis as the time between baseline and the timepoint of maximal inhibition of CMAP amplitude of stimulated EDB. Participants with maximal effect of CMAP total amplitude were reported. | The PD analysis set consisted of all participants from the randomized set who received the appropriate dose of study treatment and had CMAP recorded for baseline and at least 1 post-baseline assessment. | Posted | Count of Participants | Participants | No | At Weeks 1, 4, 8 and 20 |
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Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to Week 40
The Safety analysis set consisted of all participants who received at least 1 dose of study treatment.
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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 | Dysport 40 U | Participants received a single IM injection of Dysport 40 U in the EDB muscle on Day 1. | 0 | 15 | 10 | 15 | 11 | 15 |
| EG001 | Botox 16 U | Participants received a single IM injection of Botox 16 U in the EDB muscle on Day 1. | 0 | 15 | 2 | 15 | 10 | 15 |
| EG002 | Xeomin 16 U | Participants received a single IM injection of Xeomin 16 U in the EDB muscle on Day 1. | 0 | 15 | 5 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurent Pons/Clinical Pharmacology Director | Ipsen Innovation | see email | clinical.trials@ipsen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Apr 28, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| C545476 | incobotulinumtoxinA |
| 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 |
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| The adjusted mean, SE and 95% CI of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix. | MMRM model | 0.1620 | Treatment difference | -10.61 | 2-Sided | 95 | -25.69 | 4.47 | Superiority |
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