Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS
NCT ID: NCT02273635
Last Updated: 2014-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2014-09-30
2017-04-30
Brief Summary
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The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.
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Detailed Description
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* Delay in the disability capacity progression through the Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) at 24 months compared to the baseline.
* Delay in cognitive impairment by means of Paced Auditory Serial Addition Test (PASAT), Symbol Digit Modalities Test (SDMT) and depression (Beck) at 24 months compared to the baseline.
* Quality of life Multiple Sclerosis Impact Scale (MSIS 29) and fatigue (Krupp) through parameters reported by the patients at at 24 months compared to the baseline.
* Tolerability of andrographolide measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 months.
* Delay in the decrease in brain volume measured by Magnetic Resonance (MR) at 24 months compared to the baseline.
* Number and volume of new lesions or larger size in T2 by MR at 24 months compared to the baseline.
* Number of new hipointense lesions in T1 or (gadolinium captive) by MR at 24 months compared to the baseline.
* Delay in the retineal thinning measured by Optical Coherence Tomography (OCT) and visual field at 24 months compared to the baseline.
* Safety of andrographolide at 24 months through the record of adverse effects in symptom dairy and programmed interviews.
2. Explore the pharmacokinetic of andrographolide 140 mg administered orally twice day in:
* bio availability and concentration of andrographolide in the patients with treatment.
* half-life, maximum concentration, clearance of andrographolide in equilibrium state.
3. Determine the immunomodulatory effects of andrographolide 140 mg administered twice a day orally on lymphocyte populations in patients through the:
* Determination of Th1, Th2, Th17 and Treg lymphocyte sub-populations.
* Determination of cytokines IFNgama, TNFalpha, IL2, IL17alpha and TGFbeta.
Population: adult patients, men and women with progressive forms of MS. The number of patients to be selected will be 68, to randomly assign 34 patients to each group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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andrographolides
Coated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months.
Andrographolides
140 mg andrographolides coated tablets twice a day orally administered for 24 months.
sugar tablets
Coated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months.
placebo
140 mg excipients coated tablets twice a day orally administered for 24 months
Interventions
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placebo
140 mg excipients coated tablets twice a day orally administered for 24 months
Andrographolides
140 mg andrographolides coated tablets twice a day orally administered for 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Current Immunomodulatory or immunosuppressive therapy
* Uncontrolled systemic diseases not controlled or treated with immunotherapy (i.e Rheumatoid Arthritis, Lupus Erythematosus).
* Pregnant women
18 Years
70 Years
ALL
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
University of Chile
OTHER
Universidad Austral de Chile
OTHER
Innobioscience SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Juan L Hancke, DVM, PhD
Role: STUDY_DIRECTOR
Universidad Austral de Chile
Locations
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Multiple Sclerosis Centre, Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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Iruretagoyena MI, Tobar JA, Gonzalez PA, Sepulveda SE, Figueroa CA, Burgos RA, Hancke JL, Kalergis AM. Andrographolide interferes with T cell activation and reduces experimental autoimmune encephalomyelitis in the mouse. J Pharmacol Exp Ther. 2005 Jan;312(1):366-72. doi: 10.1124/jpet.104.072512. Epub 2004 Aug 26.
Iruretagoyena MI, Sepulveda SE, Lezana JP, Hermoso M, Bronfman M, Gutierrez MA, Jacobelli SH, Kalergis AM. Inhibition of nuclear factor-kappa B enhances the capacity of immature dendritic cells to induce antigen-specific tolerance in experimental autoimmune encephalomyelitis. J Pharmacol Exp Ther. 2006 Jul;318(1):59-67. doi: 10.1124/jpet.106.103259. Epub 2006 Apr 5.
Burgos RA, Hancke JL, Bertoglio JC, Aguirre V, Arriagada S, Calvo M, Caceres DD. Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial. Clin Rheumatol. 2009 Aug;28(8):931-46. doi: 10.1007/s10067-009-1180-5. Epub 2009 Apr 29.
Cabrera D, Gutierrez J, Cabello-Verrugio C, Morales MG, Mezzano S, Fadic R, Casar JC, Hancke JL, Brandan E. Andrographolide attenuates skeletal muscle dystrophy in mdx mice and increases efficiency of cell therapy by reducing fibrosis. Skelet Muscle. 2014 Mar 21;4:6. doi: 10.1186/2044-5040-4-6. eCollection 2014.
Carretta MD, Alarcon P, Jara E, Solis L, Hancke JL, Concha II, Hidalgo MA, Burgos RA. Andrographolide reduces IL-2 production in T-cells by interfering with NFAT and MAPK activation. Eur J Pharmacol. 2009 Jan 14;602(2-3):413-21. doi: 10.1016/j.ejphar.2008.11.011. Epub 2008 Nov 13.
Burgos RA, Seguel K, Perez M, Meneses A, Ortega M, Guarda MI, Loaiza A, Hancke JL. Andrographolide inhibits IFN-gamma and IL-2 cytokine production and protects against cell apoptosis. Planta Med. 2005 May;71(5):429-34. doi: 10.1055/s-2005-864138.
Hidalgo MA, Romero A, Figueroa J, Cortes P, Concha II, Hancke JL, Burgos RA. Andrographolide interferes with binding of nuclear factor-kappaB to DNA in HL-60-derived neutrophilic cells. Br J Pharmacol. 2005 Mar;144(5):680-6. doi: 10.1038/sj.bjp.0706105.
Sandborn WJ, Targan SR, Byers VS, Rutty DA, Mu H, Zhang X, Tang T. Andrographis paniculata extract (HMPL-004) for active ulcerative colitis. Am J Gastroenterol. 2013 Jan;108(1):90-8. doi: 10.1038/ajg.2012.340. Epub 2012 Oct 9.
Tang T, Targan SR, Li ZS, Xu C, Byers VS, Sandborn WJ. Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine. Aliment Pharmacol Ther. 2011 Jan;33(2):194-202. doi: 10.1111/j.1365-2036.2010.04515.x. Epub 2010 Nov 30.
Ciampi E, Uribe-San-Martin R, Carcamo C, Cruz JP, Reyes A, Reyes D, Pinto C, Vasquez M, Burgos RA, Hancke J. Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial. BMC Neurol. 2020 May 7;20(1):173. doi: 10.1186/s12883-020-01745-w.
Other Identifiers
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14-391
Identifier Type: OTHER
Identifier Source: secondary_id
14PIE-26946CORFO
Identifier Type: -
Identifier Source: org_study_id
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