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Trial registered on ANZCTR
Registration number
ACTRN12611000077965
Ethics application status
Approved
Date submitted
18/01/2011
Date registered
21/01/2011
Date last updated
29/11/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Healthy Volunteer Study to Determine the Safety and Tolerability of MT10109 (Clostridium Botulinum Toxin Type A) in Comparison to Botox(Registered Trademark)
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Scientific title
A Randomised, Double-Blind, Intra-Individual Controlled, Single-Center, Phase I Dose Escalation Healthy Volunteer Study to Determine the Safety and Tolerability of MT10109 (Clostridium Botulinum Toxin Type A) in Comparison to Botox(Registered Trademark)
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Secondary ID [1]
253393
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MT_GPRT_EDB01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Muscle relaxation in Extensor Digitorum Brevis muscle
260946
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Condition category
Condition code
Other
259085
259085
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Musculoskeletal
259127
259127
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
MT10109: Clostridium Botulinum Toxin Type A.
Subjects will be administered a single equivalent dose of MT10109 by intramuscular injection to the EDB muscle of either the left or right foot, the comparator will be administered to the other foot. Four cohorts of eligible subjects will be studied; Group A (2.5 U dose), Group B (5 U dose), Group C (10 U dose), and Group D (20 U dose).
The foot in which the drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
Subjects will be followed up for 90 days post injection.
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Intervention code [1]
257839
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Treatment: Drugs
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Comparator / control treatment
Botox (Registered Trademark): Clostridium Botulinum Toxin Type A
Subjects will be administered a single equivalent dose of Botox (registered trademark) by intramuscular injection to the EDB muscle of either the left or right foot, the intervention will be administered to the other foot. Four cohorts of eligible subjects will be studied; Group A (2.5 U dose), Group B (5 U dose), Group C (10 U dose), and Group D (20 U dose).
The foot in which the drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
Subjects will be followed up for 90 days post injection.
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Control group
Active
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Outcomes
Primary outcome [1]
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1. To determine the safety and tolerability of a single administration of MT10109 at a range of doses injected into the extensor digitorum brevis (EDB) muscle of one foot, compared with a single administration of Botox at a range of equal doses injected into the same muscle of the contralateral foot.
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Assessment method [1]
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Timepoint [1]
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Clinic Assessments at Post injection Day 3, 7, 14, 30, 45, 60 and 90, and telephone calls post injection Day 1, 5, 11, 21 and 38.
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Secondary outcome [1]
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1. To determine the preliminary effectiveness of a single administration of MT10109 at a range of doses injected into the extensor digitorum brevis (EDB) muscle of one foot, compared with a single administration of Botox at a range of equal doses injected into the same muscle of the contralateral foot, as determined by surface EMG (electromyography).
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Assessment method [1]
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Timepoint [1]
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Clinic assessments at Post injection Day 3, 7, 14, 30, 45, 60 and 90
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Secondary outcome [2]
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2. To determine the preliminary systemic effects of a single administration of MT10109, at the aforementioned doses.
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Assessment method [2]
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Timepoint [2]
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Clinic assessments at Post injection Day 3, 7, 14, 30, 45, 60 and 90
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Eligibility
Key inclusion criteria
1. Subjects with compound muscle action potential (CMAP) M-wave amplitude of the extensor digitorum brevis muscle of = 4.0 mV, CMAP M-wave amplitude of the Abductor hallicis muscle of = 5.0 mV, and CMAP M-wave amplitude of the Abductor digiti quinti muscle of = 5.0 mV.
2. Subjects with a normal muscle power of the toes (score = 5) on the Medical Research Council (MRC) scale.
3. Have no clinically significant medical or neurological conditions.
5. Able to attend all assessment visits.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Subjects who have previously been treated with botulinum toxin type A.
2. Subjects who had childhood botulism.
3. Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation).
4. Subjects who have a pacemaker or other heart device.
5. Subjects with peripheral neuropathy and/or an accessary peroneal nerve.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each subject will receive a singe injection of MT10109 injected into the Extensor Digitorum Brevis (EDB) muscle of one foot and a single injection of Botox injected into the EDB muscle of the other foot. An unblinded pharmacist will prepare the injections, according to a randomisation schedule, and all other study staff and subjects will be blinded as to which treatment in administered to which foot.
The pharmacist who prepares the injections will allocate to either the right or left foot based on a randomisation schedule
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Intra-individual controlled.
Subjects will be administered a single equivalent dose of MT10109 by intramuscular injection to the EDB muscle of either the left or right foot, the comparator will be administered to the other foot. Four cohorts of eligible subjects will be studied at escalating dose levels.
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
258309
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Commercial sector/Industry
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Name [1]
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Medytox, Inc
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Address [1]
258309
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641-4 Gak-ri, Ochang-eup, Cheongwon-gun,
Chungcheonbuk-do
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Country [1]
258309
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Korea, Republic Of
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Primary sponsor type
Commercial sector/Industry
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Name
Medytox, Inc
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Address
641-4 Gak-ri, Ochang-eup, Cheongwon-gun,
Chungcheonbuk-do
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Country
Korea, Republic Of
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Secondary sponsor category [1]
257474
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Commercial sector/Industry
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Name [1]
257474
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Clinical Network Services (CNS) Pty Ltd
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Address [1]
257474
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Level 4, 88 Jephson St
Toowong, QLD 4066
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Country [1]
257474
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260297
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QIMR Human Research Ethics Committee
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Ethics committee address [1]
260297
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Queensland Institute of Medical Research Post Office,
Royal Brisbane and Women's Hospital
BRISBANE QLD 4029
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Ethics committee country [1]
260297
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Australia
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Date submitted for ethics approval [1]
260297
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Approval date [1]
260297
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05/11/2010
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Ethics approval number [1]
260297
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EC00278
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Summary
Brief summary
This study is designed to compare the safety and efficacy of the investigational drug MT10109, a new formulation of Clostridium Botulinum Toxin Type A compared to Botox (Registered trademark). Subjects will have a single injection of MT10109 injected into the Extensor Digitorum Brevis (EDB) muscle of one foot and an equivalent dosage of Botox injected into the other foot.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32084
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Address
32084
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Country
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Phone
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Fax
32084
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Email
32084
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Contact person for public queries
Name
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Q-Pharm Pty Ltd
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Address
15331
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Level D (Clinic and Recruitment & Outpatients)
Clive Berghofer Cancer Research Centre (CBCRC)
300C Herston Road
Herston
QLD 4006
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Country
15331
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Australia
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Phone
15331
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+61 7 3845 3620
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Fax
15331
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+61 7 3845 3630
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Email
15331
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[email protected]
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Contact person for scientific queries
Name
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Dimity Fleming
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Address
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Level 4, 88 Jephson St
Toowong QLD 4066
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Country
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Australia
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Phone
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+61 7 3719 6000
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Fax
6259
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Email
6259
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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