NCT03317717

Brief Summary

This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

October 18, 2017

Last Update Submit

March 25, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle

    percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline

    day 14, 30, 60, 90

Study Arms (5)

botulinum toxin 2U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 5U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 10U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 20U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 30U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

Interventions

MeditoxinDRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

botulinum toxin 10Ubotulinum toxin 20Ubotulinum toxin 2Ubotulinum toxin 30Ubotulinum toxin 5U
BotoxDRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

botulinum toxin 10Ubotulinum toxin 20Ubotulinum toxin 2Ubotulinum toxin 30Ubotulinum toxin 5U

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male adults aged between 20 and 45
  • Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV

You may not qualify if:

  • Have history of childhood botulism
  • Have a pacemaker or any other heart device
  • Have peripheral neuropathy or accessary peroneal nerve
  • Have history of lower limb myotomy or denervation surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, St. Paul's Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 23, 2017

Study Start

October 12, 2017

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

KR(1)