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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)
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)
Secondary ID [1] 253393 0
MT_GPRT_EDB01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle relaxation in Extensor Digitorum Brevis muscle 260946 0
Condition category
Condition code
Other 259085 259085 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Musculoskeletal 259127 259127 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257839 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 259937 0
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.
Timepoint [1] 259937 0
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.
Secondary outcome [1] 268843 0
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).
Timepoint [1] 268843 0
Clinic assessments at Post injection Day 3, 7, 14, 30, 45, 60 and 90
Secondary outcome [2] 268844 0
2. To determine the preliminary systemic effects of a single administration of MT10109, at the aforementioned doses.
Timepoint [2] 268844 0
Clinic assessments at Post injection Day 3, 7, 14, 30, 45, 60 and 90

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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258309 0
Commercial sector/Industry
Name [1] 258309 0
Medytox, Inc
Address [1] 258309 0
641-4 Gak-ri, Ochang-eup, Cheongwon-gun,
Chungcheonbuk-do
Country [1] 258309 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
Medytox, Inc
Address
641-4 Gak-ri, Ochang-eup, Cheongwon-gun,
Chungcheonbuk-do
Country
Korea, Republic Of
Secondary sponsor category [1] 257474 0
Commercial sector/Industry
Name [1] 257474 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 257474 0
Level 4, 88 Jephson St
Toowong, QLD 4066
Country [1] 257474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260297 0
QIMR Human Research Ethics Committee
Ethics committee address [1] 260297 0
Queensland Institute of Medical Research Post Office,
Royal Brisbane and Women's Hospital
BRISBANE QLD 4029
Ethics committee country [1] 260297 0
Australia
Date submitted for ethics approval [1] 260297 0
Approval date [1] 260297 0
05/11/2010
Ethics approval number [1] 260297 0
EC00278

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32084 0
Address 32084 0
Country 32084 0
Phone 32084 0
Fax 32084 0
Email 32084 0
Contact person for public queries
Name 15331 0
Q-Pharm Pty Ltd
Address 15331 0
Level D (Clinic and Recruitment & Outpatients)
Clive Berghofer Cancer Research Centre (CBCRC)
300C Herston Road
Herston
QLD 4006
Country 15331 0
Australia
Phone 15331 0
+61 7 3845 3620
Fax 15331 0
+61 7 3845 3630
Email 15331 0
volunteers@qpharm.com.au
Contact person for scientific queries
Name 6259 0
Dimity Fleming
Address 6259 0
Level 4, 88 Jephson St
Toowong QLD 4066
Country 6259 0
Australia
Phone 6259 0
+61 7 3719 6000
Fax 6259 0
Email 6259 0
cns@clinical.net.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary