A Phase 1 interventional study of Botulinum toxin type A and Botulinum toxin type A in Healthy Participants, sponsored by Ipsen. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Ipsen · Phase 1, Interventional, and Treatment
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)
Ipsen is the lead sponsor of 288 studies on the registry; 16 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 21 (81%) have results posted.
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Exclusion Criteria:
40 Units (U) Intramuscular (IM) injection at day 1.
Biological: Botulinum toxin type A
16U IM at day 1.
Biological: Botulinum toxin type A
16U IM at day 1.
Biological: Botulinum toxin type A
Intramuscular Injection, concentration 300 units (U)
Also known as: abobotulinumtoxinA (Dysport®)
Intramuscular Injection, concentration 50 U
Also known as: onabotulinumtoxinA (Botox®)
Intramuscular Injection, concentration 50 U
Also known as: incobotulinumtoxinA (Xeomin®)
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.
Time frame: Baseline (Day 1) and Week 28
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Weeks 1, 4, 8 and 20
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.
| Milestone | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Completed | 15 | 15 | 15 |
| Not completed | 0 | 0 | 0 |
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.
| % of AM of CMAP total amplitude | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28 | 73.62 ± 5.26 | 74.78 ± 5.26 | 84.23 ± 5.25 |
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.
| % of AM of CMAP total amplitude | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Change From Baseline in AM % of CMAP Total Amplitude at Week 40 | 77.10 ± 5.09 | 81.83 ± 5.10 | 92.01 ± 5.09 |
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.
| percentage of participants | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Week 28 | 33.3 (11.8 to 61.6) | 26.7 (7.8 to 55.1) | 53.3 (26.6 to 78.7) |
| Week 40 | 33.3 (11.8 to 61.6) | 33.3 (11.8 to 61.6) | 66.7 (38.4 to 88.2) |
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.
| weeks | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Time to Onset of Action of Study Intervention | 1.00 (0.7 to 1.6) | 1.00 (0.7 to 1.1) | 1.00 (0.9 to 4.0) |
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.
| weeks | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Duration of Response | 18.29 (7.0 to 19.0) | 10.86 (7.3 to 31.4) | 17.07 (3.1 to 38.6) |
Maximal inhibition was defined as the maximal measured inhibition of CMAP total amplitude of stimulated EDB.
| percentage of inhibition | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude | 39.79 (31.23 to 48.35) | 38.55 (33.99 to 43.10) | 44.99 (36.68 to 53.30) |
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.
| Participants | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Week 1 | 11 | 13 | 11 |
| Week 4 | 2 | 1 | 4 |
| Week 8 | 1 | 1 | 0 |
| Week 20 | 1 | 0 | 0 |
Collected over Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to Week 40. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dysport 40 U | 0/15 (0%) | 10/15 (66.7%) | 11/15 (73.3%) |
| Botox 16 U | 0/15 (0%) | 2/15 (13.3%) | 10/15 (66.7%) |
| Xeomin 16 U | 0/15 (0%) | 5/15 (33.3%) | 14/15 (93.3%) |
| Event | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| Covid-19Infections and infestations | 10/15 | 2/15 | 4/15 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/15 | 0/15 | 1/15 |
| EnteritisGastrointestinal disorders | 0/15 | 0/15 | 1/15 |
| Event | Dysport 40 U | Botox 16 U | Xeomin 16 U |
|---|---|---|---|
| HeadacheNervous system disorders | 2/15 | 1/15 | 5/15 |
| Viral infectionInfections and infestations | 2/15 | 2/15 | 4/15 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/15 | 3/15 | 2/15 |
| Soft tissue injuryInjury, poisoning and procedural complications | 0/15 | 2/15 | 1/15 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/15 | 1/15 | 1/15 |
| Back painMusculoskeletal and connective tissue disorders | 0/15 | 1/15 | 2/15 |
| HypoaesthesiaNervous system disorders | 2/15 | 2/15 | 0/15 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/15 | 1/15 | 0/15 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/15 | 1/15 | 2/15 |
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.
| Age, Continuous(years) | Dysport 40 U | Botox 16 U | Xeomin 16 U | Total |
|---|---|---|---|---|
| Mean | 36.2 ± 11.3 | 35.3 ± 12.3 | 34.8 ± 13.9 | 35.4 ± 12.3 |
| Sex: Female, Male(Participants) | Dysport 40 U | Botox 16 U | Xeomin 16 U | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 15 | 15 | 15 | 45 |
| Race and Ethnicity Not Collected(Participants) | Dysport 40 U | Botox 16 U | Xeomin 16 U | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
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Studies of the drug tested here: Botulinum toxin type A