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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04970407
Recruitment Status : Completed
First Posted : July 21, 2021
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief 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)

Condition or disease Intervention/treatment Phase
Healthy Participants Biological: Botulinum toxin type A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 6, 2021
Actual Primary Completion Date : March 16, 2022
Actual Study Completion Date : June 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Dysport®
40 Units (U) Intramuscular (IM) injection at day 1.
Biological: Botulinum toxin type A
Intramuscular Injection, concentration 300 units (U)
Other Name: abobotulinumtoxinA (Dysport®)

Active Comparator: Botox®
16U IM at day 1.
Biological: Botulinum toxin type A
Intramuscular Injection, concentration 50 U
Other Name: onabotulinumtoxinA (Botox®)

Active Comparator: Xeomin®
16U IM at day 1.
Biological: Botulinum toxin type A
Intramuscular Injection, concentration 50 U
Other Name: incobotulinumtoxinA (Xeomin®)




Primary Outcome Measures :
  1. CMAP total amplitude measured as relative change from Baseline (%) [ Time Frame: week 28. ]

Secondary Outcome Measures :
  1. CMAP total amplitude measured as relative change from Baseline (%). [ Time Frame: Week 40. ]
  2. Incidence of recovery of CMAP total amplitude, defined as total amplitude return to at least 85% of the Baseline value. [ Time Frame: Week 28. ]
  3. Incidence of recovery of CMAP total amplitude. [ Time Frame: Week 40. ]
  4. Time to onset of action defined as first timepoint where EDB CMAP total amplitude is 85% or lower than the Baseline value. [ Time Frame: From baseline to week 40. ]
  5. Duration of response defined as time period between time to onset and time to recovery. [ Time Frame: From baseline to week 40. ]
    Time to recovery is defined as the first timepoint (post time to onset of action and assuming that % of baseline value keeps on decreasing) where EDB CMAP total amplitude returns to at least 85% of the baseline value.

  6. Maximal inhibition (maximal effect) reached. [ Time Frame: From baseline to week 40. ]
    Maximal Effect for each participant is defined as the maximal measured inhibition of CMAP amplitude of stimulated EDB. Maximal Effect will be analysed descriptively.

  7. Time to maximal effect on the CMAP total amplitude of stimulated EDB. [ Time Frame: From baseline to week 40. ]
  8. Type, incidence and severity of TEAEs, SAEs, AEs (or SAEs) leading to withdrawals [ Time Frame: From baseline to week 40. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970407


Locations
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United Kingdom
Mac Research Clinical research Unit
Manchester, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04970407    
Other Study ID Numbers: D-FR-52120-279
2021-000802-14 ( EudraCT Number )
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents