Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®

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: NCT03796351
Recruitment Status : Completed
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief Summary:
This study design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days and pharmacodynamic and safety assessments will be conducted for total 90days.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: MT10107 Drug: Botox Phase 1

Detailed Description:

This is a randomised, double-blind, intra-individual controlled, dose escalation study to assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the first-in-human study for MT10107, and will be performed in healthy volunteers.

Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).

The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Randomized, Double-blind, Intra-Individual Controlled, Single-Center, Phase 1 Healthy Volunteer Study
Study Start Date : September 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: MT10107(botulinum toxin type A)
Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group.
Drug: MT10107

Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).

The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.

Other Name: Coretox

Active Comparator: BOTOX® 50U(botulinum toxin type A)
Subjects will be administered a single equivalent dose of BOTOX® 50U by intramuscular injection to the EDB muscles of contralateral feet in five treatment group.
Drug: Botox

Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).

The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.





Primary Outcome Measures :
  1. The percentage reduction in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value. [ Time Frame: 30 days after the injection ]
    percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline


Secondary Outcome Measures :
  1. The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG. [ Time Frame: 14, 30 and 90 days after the injection ]
    percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the adjacent muscles (AH and ADQ) from baseline

  2. The percentage reduction in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value. [ Time Frame: 14 and 90 days after the injection ]
    percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male adults aged between 20 and 65 years
  2. Subjects with CMAP M-wave amplitude of the EDM muscle of ≥ 4.0 mV, CMAP M-wave amplitude of the AH muscle of ≥ 5.0 mV, and CMAP M-wave amplitude of the ADQ muscle of ≥ 5.0 mV.
  3. Have no clinically significant medical conditions.
  4. Able to provide written informed consent.
  5. Able to attend all assessment visits.

Exclusion Criteria:

  1. Subjects who have previously been treated in 3 month with botulinum toxin type A.
  2. Subjects who had childhood botulism.
  3. Subjects who have a pacemaker or other heart device.
  4. Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation).
  5. Subjects with peripheral neuropathy and/or an accessary peroneal nerve.
  6. Participation in any research study involving drug administration and/or significant blood loss.
  7. Subjects with laboratory (haematology and biochemistry) or urinalysis results out of the normal range and considered to be of clinical significance by the investigator.
  8. Subjects with a history of alcohol abuse and/or drug habituation.
  9. Subjects who take regular medication.
  10. Subjects with allergy or hypersensitivity to the investigational products or their components
  11. Subjects who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, Benzodiazepines
  12. Subjects who do not agree to use barrier method contraception (i.e. condoms) for the duration of the study.
  13. Subjects who participate in regular physical activity/sport, which requires high load and intensity to the foot and cannot be stopped for the duration of the study.
  14. Patients who are not eligible for this study at the discretion of the investigator

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): NCT03796351


Locations
Layout table for location information
Korea, Republic of
The Catholic University of Korea, St. Paul's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Medy-Tox
Investigators
Layout table for investigator information
Principal Investigator: MyungEun Chung Catholic University of Korea Saint Paul's Hospital

Layout table for additonal information
Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03796351     History of Changes
Other Study ID Numbers: MT_PRT_EDB01
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: September 2012

Additional relevant MeSH terms:
Layout table for MeSH terms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
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