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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02273635 |
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Date of registration:
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03/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS
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Scientific title:
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Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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68 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02273635 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Claudia A Carcamo, MD, PhD. |
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Address:
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Telephone:
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56 2 3546885 |
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Email:
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ccarcamo@med.puc.cl |
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Affiliation:
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Name:
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Claudia A Carcamo, MD, PhD |
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Address:
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Telephone:
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+56223546885 |
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Email:
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ccarcamo@med.puc.cl |
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Affiliation:
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Name:
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Juan L Hancke, DVM, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Austral de Chile |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed Informed Consent previous to the initiation of the study before any
evaluation.
- Men and women > 18 years of age with Minimental > 24.
- Patients with diagnosis of secondary progressive MS without relapses or primary
progressive MS according to the criteria of McDonald 2010.
Exclusion Criteria:
- Relapsing-remitting MS
- Current Immunomodulatory or immunosuppressive therapy
- Uncontrolled systemic diseases not controlled or treated with immunotherapy (i.e
Rheumatoid Arthritis, Lupus Erythematosus).
- Pregnant women
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Secondary Progressive
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Primary Progressive Multiple Sclerosis
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Intervention(s)
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Drug: placebo
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Drug: Andrographolides
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Primary Outcome(s)
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Brain atrophy in patients with progressive forms of MS
[Time Frame: 24 months]
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Secondary Outcome(s)
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Depression by Beck scale
[Time Frame: 24 months]
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Expanded Disability Status Scale (EDSS)
[Time Frame: 24 months]
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New hypointense lesions in T1
[Time Frame: 24 months]
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Number of new T2 lesions
[Time Frame: 24 months]
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Optical Coherence Tomography (OCT)
[Time Frame: 24 months]
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Record of adverse effects in daily symptoms and programmed interviews.
[Time Frame: 24 months]
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Visual field
[Time Frame: 24 months]
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Fatigue by Krupp scale
[Time Frame: 24 months]
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Number of new gadolinium enhancement lesions in T1 by MR
[Time Frame: 24 months]
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Quality of life Multiple Sclerosis Impact Scale (MSIS 29)
[Time Frame: 24 months]
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Symbol Digit Modalities Test (SDMT)
[Time Frame: 24 months]
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Volume of new T2 lesions
[Time Frame: 24 months]
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Paced Auditory Serial Addition Test (PASAT)
[Time Frame: 24 months]
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Treatment Satisfaction Questionnaire for Medication (TSQM)
[Time Frame: 24 months]
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Multiple Sclerosis Functional Composite (MSFC)
[Time Frame: 24 months]
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Secondary ID(s)
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14PIE-26946CORFO
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14-391
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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