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Trial registered on ANZCTR


Trial ID
ACTRN12606000037505
Ethics application status
Approved
Date submitted
24/01/2006
Date registered
25/01/2006
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The safety of Cpn10 in patients with multiple sclerosis
Scientific title
A Multicentre, phase IIa clinical trial to assess the safety, tolerability and pharmacodynamics of Cpn10 administered as multiple intrvenous injections in volunteers with multiple sclerosis
Secondary ID [1] 232 0
CBio Ltd: CBIO 2004-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 999 0
Condition category
Condition code
Neurological 1074 1074 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cpn10 5mg once per week or
Cpn10 5mg twice per week or

Given as intravenous injections for 12 weeks
Intervention code [1] 860 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1440 0
Adverse event profile
Timepoint [1] 1440 0
Over the 12 week treatment period and 4 week follow-up
Secondary outcome [1] 2548 0
1. Assess serological markers of biological activity, to evaluate the dosing regime.
Timepoint [1] 2548 0
Over the 12 week treatment period.
Secondary outcome [2] 2549 0
2. Assess the development of anti-Cpn10 antibodies.
Timepoint [2] 2549 0
Over the 12 week treatment and 4 week follow-up.
Secondary outcome [3] 2550 0
3. Assess the clinical impact of Cpn10, using surrogate markers and clinical scales.
Timepoint [3] 2550 0
Over the 12 week treatment period.

Eligibility
Key inclusion criteria
1. Have a diagnosis of MS, as defined by the McDonald criteria. 2. Have either relapse/remitting or secondary progressive disease. 3. Have a Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 6.5. 4.Have an abnormal MRI at initial assessment, as defined by the Paty criteria, i.e. greater than 4 lesions, or 3 lesions of which 1 is periventricular. 5. Patients with adequate venous access in their left or right arm to allow collection of a number of blood samples via a venepuncture. 6. Fluent in the English language. 7. Have voluntarily given written informed consent to participate in this study.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other definable cause for clinical presentation (i.e. not MS).2. Primary progressive disease course.3. Clinically isolated syndrome even when sufficient paraclinical evidence to meet McDonald criteria for a diagnosis of MS.4. Normal MRI brain at initial assessment (Paty criteria).5. Exacerbation in 28 days prior to treatment onset (i.e. during 4 week lead-in time).6. Administration of any other disease modifying therapy in the preceding 3 months (beta-interferon 1a, beta-interferon 1b, glatiramer acetate, azathioprine, mitoxantrone, prednisolone, methylprednisolone or other steroid agent).7. Except for any primarily immunomodulatory drugs, standard drugs with minor immunological effects (e.g. tricyclic antidepressants), including illicit drugs, will be allowed at the Investigator's discretion.8. Other severe illness that might interfere with assessment or hamper patients ability to complete the study.9. Abnormal haematological or biochemical parameters at initial assessment or study onset (based on reference ranges from the diagnostic facility); exclusion will be at the Investigator's discretion.10. Anti-nuclear antibody (ANA) titre of 1 in 80 or greater at screening.11. Positive pregnancy test at initial assessment or study onset.12. Unwilling or unable to take adequate contraceptive precautions for the period of the study.13. History of any psychiatric illness which may impair the ability to provide written informed consent.14. Poor compliers or those unlikely to attend.15. Inability to have MRI scans, based on completion of a standard questionnaire by each patient at screening. Specifically:(a) Contraindication to MR scanning (absolute and relative)i. Cardiac pacemaker or retained pacemaker leadsii. Cerebral aneurysm clipsiii. Implanted neuro-stimulators or electronic devices, including Cochlear implantiv. History of penetrating eye injuryv. Schrapnel(b) Claustrophobia16. Inability to receive Gadolinium injections for MRI scans, due to:(a) Previous sensitivity to Gadolinium(b) Lactating(c) Known iron overload(d) Sickle cell anaemia(e) Haemolytic anaemia(d) Thalassaemia17. Participation in a clinical trial, or has received any experimental therapy, within the last 30 days.18. Donated or lost a significant amount of blood (e.g. 550 mL) within the past 12 weeks.

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)
sequential code numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The blocked random allocation sequence was generated in SAS using Proc Plan.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety
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] 1177 0
Commercial sector/Industry
Name [1] 1177 0
CBio Limited
Address [1] 1177 0
85 Brandl St
Eight Mile Plains QLD 4113
Country [1] 1177 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CBio Limited
Address
85 Brandl St
Eight Mile Plains QLD 4133
Country
Australia
Secondary sponsor category [1] 1037 0
None
Name [1] 1037 0
N/A
Address [1] 1037 0
Country [1] 1037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2494 0
CMAX Royal Adelaide Hospital
Ethics committee address [1] 2494 0
North Terrace Adelaide SA 5000
Ethics committee country [1] 2494 0
Australia
Date submitted for ethics approval [1] 2494 0
Approval date [1] 2494 0
Ethics approval number [1] 2494 0
Ethics committee name [2] 2495 0
Griffith School of Medicine
Ethics committee address [2] 2495 0
Gold Coast Campus, Griffith University, QLD
Ethics committee country [2] 2495 0
Australia
Date submitted for ethics approval [2] 2495 0
Approval date [2] 2495 0
Ethics approval number [2] 2495 0

Summary
Brief summary
Safety of Cpn10 in patients with multiple sclerosis. The study personnel, patients and sponsor are all blinded as to whether the patient received either of the two doses being trialed or placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36360 0
Address 36360 0
Country 36360 0
Phone 36360 0
Fax 36360 0
Email 36360 0
Contact person for public queries
Name 10049 0
Bronwyn Williams
Address 10049 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 10049 0
Australia
Phone 10049 0
+61 7 38414844
Fax 10049 0
+61 7 38418189
Email 10049 0
bronwyn.williams@cbio.com.au
Contact person for scientific queries
Name 977 0
Dr Dennis Feeney
Address 977 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 977 0
Australia
Phone 977 0
+61 7 38414844
Fax 977 0
+61 7 38418189
Email 977 0
dennis.feeney@cbio.com.au