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Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS

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ClinicalTrials.gov Identifier: NCT02273635
Recruitment Status : Unknown
Verified October 2014 by Innobioscience SpA.
Recruitment status was:  Recruiting
First Posted : October 24, 2014
Last Update Posted : October 27, 2014
Sponsor:
Collaborators:
Pontificia Universidad Catolica de Chile
University of Chile
Universidad Austral de Chile
Information provided by (Responsible Party):
Innobioscience SpA

Brief 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).

The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.


Condition or disease Intervention/treatment Phase
Primary Progressive Multiple Sclerosis Multiple Sclerosis, Secondary Progressive Drug: Andrographolides Drug: placebo Phase 1 Phase 2

Detailed Description:
  1. 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.
  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: andrographolides
Coated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months.
Drug: Andrographolides
140 mg andrographolides coated tablets twice a day orally administered for 24 months.
Other Names:
  • andrographolide, neoandrographolide, deoxyandrographolide
  • IB-MS 14

Placebo Comparator: sugar tablets
Coated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months.
Drug: placebo
140 mg excipients coated tablets twice a day orally administered for 24 months




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Expanded Disability Status Scale (EDSS) [ Time Frame: 24 months ]
    Delay in the disability capacity progression through the Expanded Disability Status Scale (EDSS) at 24 months compared to the baseline.

  2. Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 24 months ]
    Delay in cognitive impairment by means of Paced Auditory Serial Addition Test (PASAT) at 24 months compared to the baseline.

  3. Quality of life Multiple Sclerosis Impact Scale (MSIS 29) [ Time Frame: 24 months ]
    Quality of life Multiple Sclerosis Impact Scale (MSIS 29) through parameters reported by the patients at 24 months compared to the baseline.

  4. Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 24 months ]
    Tolerability of andrographolide measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 months.

  5. Number of new T2 lesions [ Time Frame: 24 months ]
    Number of new lesions T2 by MR at 24 months compared to the baseline.

  6. New hypointense lesions in T1 [ Time Frame: 24 months ]
    Number of new hypointense lesions in T1 by MR at 24 months compared to the baseline.

  7. Optical Coherence Tomography (OCT) [ Time Frame: 24 months ]
    Delay in the retinal thinning measured by Optical Coherence Tomography (OCT) at 24 months compared to the baseline.

  8. Record of adverse effects in daily symptoms and programmed interviews. [ Time Frame: 24 months ]
    Safety of andrographolide at 24 months through the record of adverse effects in daily symptoms and programmed interviews.

  9. Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 24 months ]
    Delay in the disability capacity progression through the Multiple Sclerosis Functional Composite (MSFC) at 24 months compared to the baseline.

  10. Symbol Digit Modalities Test (SDMT) [ Time Frame: 24 months ]
    Delay in cognitive impairment by means of Symbol Digit Modalities Test (SDMT) at 24 months compared to the baseline.

  11. Depression by Beck scale [ Time Frame: 24 months ]
    Evaluate mood disorders by means of Beck scale at 24 months compared to the baseline.

  12. Fatigue by Krupp scale [ Time Frame: 24 months ]
    Evaluate fatigue by Krupp scale reported by the patients at 24 months compared to the baseline.

  13. Number of new gadolinium enhancement lesions in T1 by MR [ Time Frame: 24 months ]
    Number of new gadolinium enhancement lesions in T1 by MR at 24 months compared to the baseline.

  14. Visual field [ Time Frame: 24 months ]
    Change in visual field at 24 months compared to the baseline.

  15. Volume of new T2 lesions [ Time Frame: 24 months ]
    Volume of size in T2 by MR at 24 months compared to the baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273635


Contacts
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Contact: Claudia A Carcamo, MD, PhD +56223546885 ccarcamo@med.puc.cl
Contact: Ethel L Ciampi, MD +56223546885 anticsnap@gmail.com

Locations
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Chile
Multiple Sclerosis Centre, Pontificia Universidad Catolica de Chile Recruiting
Santiago, Metropolitana, Chile, 8330033
Contact: Claudia A Carcamo, MD, PhD.    56 2 3546885    ccarcamo@med.puc.cl   
Contact: Ana C Reyes, Nurse    56 2 3546885    acreyes@med.puc.cl   
Sponsors and Collaborators
Innobioscience SpA
Pontificia Universidad Catolica de Chile
University of Chile
Universidad Austral de Chile
Investigators
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Study Director: Juan L Hancke, DVM, PhD Universidad Austral de Chile

Publications:

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Responsible Party: Innobioscience SpA
ClinicalTrials.gov Identifier: NCT02273635    
Other Study ID Numbers: 14PIE-26946CORFO
14-391 ( Other Identifier: Comite Etico Cientifico - CEC MED UC )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Andrographolide
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors