Primary Progressive Multiple SclerosisPhase 1/2NCT02273635
Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS
A Phase 1/2 study testing Andrographolides in people with Primary Progressive Multiple Sclerosis and Multiple Sclerosis, Secondary Progressive, run by Innobioscience SpA at 1 site in Chile.
Trial summary
The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive
- What is being tested?
- Andrographolides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChile
- Study dates
- Sep 2014to Apr 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Centre, Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330033
Claudia A Carcamo, MD, PhD., 56 2 3546885, ccarcamo@med.puc.cl
Ana C Reyes, Nurse, 56 2 3546885, acreyes@med.puc.cl
About this study
Official title: 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
The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS).
The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.
Read the detailed description
- Evaluate the clinical efficacy of andrographolide 140 mg administered orally twice a day versus a placebo in:
- 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.
- 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.
- 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.
- Being tested
- Andrographolides, placebo
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndrographolidesDrug
Also called andrographolide, neoandrographolide, deoxyandrographolide, IB-MS 14
140 mg andrographolides coated tablets twice a day orally administered for 24 months.
placeboDrug
140 mg excipients coated tablets twice a day orally administered for 24 months
| Study group | Role | What they receive |
|---|---|---|
| andrographolides | Experimental | Coated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months. Receives: Drug: Andrographolides |
| sugar tablets | Placebo comparator | Coated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain atrophy in patients with progressive forms of MS
Retarding the progression of brain atrophy as measured by MR quantified by the percentage of change in volume size utilizing SIENA.
Measured: 24 months
Secondary outcomes (15)
Expanded Disability Status Scale (EDSS)
Delay in the disability capacity progression through the Expanded Disability Status Scale (EDSS) at 24 months compared to the baseline.
Measured: 24 months
Paced Auditory Serial Addition Test (PASAT)
Delay in cognitive impairment by means of Paced Auditory Serial Addition Test (PASAT) at 24 months compared to the baseline.
Measured: 24 months
Quality of life Multiple Sclerosis Impact Scale (MSIS 29)
Quality of life Multiple Sclerosis Impact Scale (MSIS 29) through parameters reported by the patients at 24 months compared to the baseline.
Measured: 24 months
Treatment Satisfaction Questionnaire for Medication (TSQM)
Tolerability of andrographolide measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 months.
Measured: 24 months
Number of new T2 lesions
Number of new lesions T2 by MR at 24 months compared to the baseline.
Measured: 24 months
New hypointense lesions in T1
Number of new hypointense lesions in T1 by MR at 24 months compared to the baseline.
Measured: 24 months
Optical Coherence Tomography (OCT)
Delay in the retinal thinning measured by Optical Coherence Tomography (OCT) at 24 months compared to the baseline.
Measured: 24 months
Record of adverse effects in daily symptoms and programmed interviews.
Safety of andrographolide at 24 months through the record of adverse effects in daily symptoms and programmed interviews.
Measured: 24 months
Multiple Sclerosis Functional Composite (MSFC)
Delay in the disability capacity progression through the Multiple Sclerosis Functional Composite (MSFC) at 24 months compared to the baseline.
Measured: 24 months
Symbol Digit Modalities Test (SDMT)
Delay in cognitive impairment by means of Symbol Digit Modalities Test (SDMT) at 24 months compared to the baseline.
Measured: 24 months
Depression by Beck scale
Evaluate mood disorders by means of Beck scale at 24 months compared to the baseline.
Measured: 24 months
Fatigue by Krupp scale
Evaluate fatigue by Krupp scale reported by the patients at 24 months compared to the baseline.
Measured: 24 months
Number of new gadolinium enhancement lesions in T1 by MR
Number of new gadolinium enhancement lesions in T1 by MR at 24 months compared to the baseline.
Measured: 24 months
Visual field
Change in visual field at 24 months compared to the baseline.
Measured: 24 months
Volume of new T2 lesions
Volume of size in T2 by MR at 24 months compared to the baseline.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innobioscience SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pontificia Universidad Catolica de Chile, University of Chile, Universidad Austral de Chile
- Responsible party
- Sponsor
- Investigators
- Juan L Hancke, DVM, PhD, Study director, Universidad Austral de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273635
- Sponsor's protocol ID
- 14PIE-26946CORFO
- Other IDs
- 14-391
- Status last verified
- Oct 2014
- First submitted
- 3 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15331658Iruretagoyena 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.
PubMed 16597709Burgos 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.
PubMed 19408036Cabrera 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.
PubMed 24655808Carretta 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.
PubMed 19038244Burgos 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.
PubMed 15931581Hidalgo 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.
PubMed 15678086Sandborn 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.
PubMed 23044768Tang 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.
PubMed 21114791Ciampi 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.
PubMed 32380977
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02273635
- Acronym / sponsor ID
- 14PIE-26946CORFO
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Innobioscience SpAIndustry (pharma, biotech, devices)
- Collaborators
- Pontificia Universidad Catolica de Chile, University of Chile, Universidad Austral de Chile
- Study start
- Sep 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS).
The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.
Detailed description
- Evaluate the clinical efficacy of andrographolide 140 mg administered orally twice a day versus a placebo in:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| andrographolides | Experimental | Drug: AndrographolidesCoated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months. |
| sugar tablets | Placebo comparator | Drug: placeboCoated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndrographolidesAlso: andrographolide, neoandrographolide, deoxyandrographolide, IB-MS 14140 mg andrographolides coated tablets twice a day orally administered for 24 months. | Drug | andrographolides |
| placebo140 mg excipients coated tablets twice a day orally administered for 24 months | Drug | sugar tablets |
Primary outcome
Brain atrophy in patients with progressive forms of MS
Time frame: 24 months
Retarding the progression of brain atrophy as measured by MR quantified by the percentage of change in volume size utilizing SIENA.
15 secondary outcomes
Expanded Disability Status Scale (EDSS)
Time frame: 24 months
Paced Auditory Serial Addition Test (PASAT)
Time frame: 24 months
Quality of life Multiple Sclerosis Impact Scale (MSIS 29)
Time frame: 24 months
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 24 months
Number of new T2 lesions
Time frame: 24 months
New hypointense lesions in T1
Time frame: 24 months
Optical Coherence Tomography (OCT)
Time frame: 24 months
Record of adverse effects in daily symptoms and programmed interviews.
Time frame: 24 months
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 24 months
Symbol Digit Modalities Test (SDMT)
Time frame: 24 months
Depression by Beck scale
Time frame: 24 months
Fatigue by Krupp scale
Time frame: 24 months
Number of new gadolinium enhancement lesions in T1 by MR
Time frame: 24 months
Visual field
Time frame: 24 months
Volume of new T2 lesions
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Background: PubMed 15331658Iruretagoyena 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.
- Background: PubMed 16597709Iruretagoyena 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.
- Background: PubMed 19408036Burgos 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.
- Background: PubMed 24655808Cabrera 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.
- Background: PubMed 19038244Carretta 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.
- Background: PubMed 15931581Burgos 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.
- Background: PubMed 15678086Hidalgo 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.
- Background: PubMed 23044768Sandborn 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.
- Background: PubMed 21114791Tang 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.
- Derived from this study: PubMed 32380977Ciampi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan L Hancke, DVM, PhD study director
Universidad Austral de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Andrographolides in people with Primary Progressive Multiple Sclerosis and Multiple Sclerosis, Secondary Progressive, run by Innobioscience SpA at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia A Carcamo, MD, PhD (+56223546885, ccarcamo@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain atrophy in patients with progressive forms of MS (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273635, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.