Healthy ParticipantsPhase 1NCT04970407

A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants

A Phase 1 study testing Botulinum toxin type A in people with Healthy Participants, run by Ipsen at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Botulinum toxin type A
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Jul 2021to 8 Jun 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant must be between18 to 65 years of age inclusive, at the time of signing the informed consent
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring
A body mass index (BMI) within the range 18 and 30 kg/m2 (inclusive).

Who cannot join

Any medical condition that may put the participant at risk with exposure to BoNT, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
Previous treatment with botulinum toxin (BoNT) (any serotype) during the past 6 months
Known hypersensitivity to any of the components of the Dysport/ Botox/ Xeomin formulation (which includes human serum albumin, lactose, sucrose) or allergy to cow's milk protein
Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Mac Research Clinical research Unit
Manchester

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomised, Double-blind, Parallel-group, Single-centre Comparative Study to Evaluate the Pharmacodynamic Profile of Dysport®, Botox®, and Xeomin® in the Extensor Digitorum Brevis (EDB) Model in Healthy Adult Male Participants

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)

Conditions: Healthy Participants
Being tested: Botulinum toxin type A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum toxin type ABiological
Also called abobotulinumtoxinA (Dysport®)
Intramuscular Injection, concentration 300 units (U)
Botulinum toxin type ABiological
Also called onabotulinumtoxinA (Botox®)
Intramuscular Injection, concentration 50 U
Botulinum toxin type ABiological
Also called incobotulinumtoxinA (Xeomin®)
Intramuscular Injection, concentration 50 U

Study groups in NCT04970407
Study group	Role	What they receive
Dysport®	Experimental	40 Units (U) Intramuscular (IM) injection at day 1. Receives: Biological: Botulinum toxin type A
Botox®	Active comparator	16U IM at day 1. Receives: Biological: Botulinum toxin type A
Xeomin®	Active comparator	16U IM at day 1. Receives: Biological: Botulinum toxin type A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (Day 1) and Week 28

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Weeks 1, 4, 8 and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20218 Jun 2022

First posted21 Jul 2021
Study start6 Jul 2021
Primary completion16 Mar 2022
Study completion8 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by IpsenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04970407
Sponsor's protocol ID: D-FR-52120-279
Other IDs: 2021-000802-14
Status last verified: Feb 2025
First submitted: 2 Jul 2021
Last updated: 19 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Double-blind, Parallel-group, Single-centre Comparative Study to Evaluate the Pharmacodynamic Profile of Dysport®, Botox®, and Xeomin® in the Extensor Digitorum Brevis (EDB) Model in Healthy Adult Male Participants
ClinicalTrials.gov ID: NCT04970407
Acronym / sponsor ID: D-FR-52120-279
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: 6 Jul 2021 (actual)
Primary completion: 16 Mar 2022 (actual)
Study completion: 8 Jun 2022 (actual)
First posted: 21 Jul 2021 (actual)
Results: Posted 1 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dysport®	Experimental	Biological: Botulinum toxin type A40 Units (U) Intramuscular (IM) injection at day 1.
Botox®	Active comparator	Biological: Botulinum toxin type A16U IM at day 1.
Xeomin®	Active comparator	Biological: Botulinum toxin type A16U IM at day 1.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participant must be between18 to 65 years of age inclusive, at the time of signing the informed consent
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring
A body mass index (BMI) within the range 18 and 30 kg/m2 (inclusive).

Key exclusion criteria (4 listed)

Any medical condition that may put the participant at risk with exposure to BoNT, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
Previous treatment with botulinum toxin (BoNT) (any serotype) during the past 6 months
Known hypersensitivity to any of the components of the Dysport/ Botox/ Xeomin formulation (which includes human serum albumin, lactose, sucrose) or allergy to cow's milk protein
Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum toxin type AAlso: abobotulinumtoxinA (Dysport®)Intramuscular Injection, concentration 300 units (U)	Biological	Dysport®
Botulinum toxin type AAlso: onabotulinumtoxinA (Botox®)Intramuscular Injection, concentration 50 U	Biological	Botox®
Botulinum toxin type AAlso: incobotulinumtoxinA (Xeomin®)Intramuscular Injection, concentration 50 U	Biological	Xeomin®

Primary outcome

Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28
Time frame: Baseline (Day 1) and 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.

6 secondary outcomes

Change From Baseline in AM % of CMAP Total Amplitude at Week 40
Time frame: Baseline (Day 1) and Week 40
Percentage of Participants With Recovery of CMAP Total Amplitude
Time frame: At Weeks 28 and 40
Time to Onset of Action of Study Intervention
Time frame: From Baseline (Day 1) up to Week 40
Duration of Response
Time frame: From Baseline (Day 1) up to Week 40
Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude
Time frame: Up to Week 40
Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude
Time frame: At Weeks 1, 4, 8 and 20

Results and safety

Results posted to the registry on 1 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dysport 40 U	15	15
Botox 16 U	15	15
Xeomin 16 U	15	15

Primary outcome: Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28

Time frame: Baseline (Day 1) and Week 28. Mean (Standard Error). Unit: % of AM of CMAP total amplitude

Measure	Dysport 40 U n = 15	Botox 16 U n = 15	Xeomin 16 U n = 15
Value	73.62 (5.26)	74.78 (5.26)	84.23 (5.25)

Dysport 40 U vs Botox 16 U: Treatment difference: -1.16 (95% CI -16.25 to 13.93), p = 0.8769, MMRM model
Dysport 40 U vs Xeomin 16 U: Treatment difference: -10.61 (95% CI -25.69 to 4.47), p = 0.1620, MMRM model

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to Week 40. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dysport 40 U	10 of 15 (66.7%)	11 of 15 (73.3%)	0 of 15
Botox 16 U	2 of 15 (13.3%)	10 of 15 (66.7%)	0 of 15
Xeomin 16 U	5 of 15 (33.3%)	14 of 15 (93.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ipsen Medical Director study director

Ipsen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Botulinum toxin type A in people with Healthy Participants, run by Ipsen at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28 (time frame: Baseline (Day 1) and Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04970407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.