The safety of Cpn10 in patients with multiple sclerosis

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2006
INTERVENTION: Cpn10 5mg once per week or Cpn10 5mg twice per week or Given as intravenous injections for 12 weeks CONDITION: Multiple Sclerosis PRIMARY OUTCOME: Adverse event profile SECONDARY OUTCOME: 1. Assess serological markers of biological activity, to evaluate the dosing regime. 2. Assess the development of anti‐Cpn10 antibodies. 3. Assess the clinical impact of Cpn10, using surrogate markers and clinical scales. 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.
Epistemonikos ID: 9f85469925e0dc6171c730c5dc8933ec87f61640
First added on: Aug 25, 2024