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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

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date October 27, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of new T2 lesions [ Time Frame: 24 months ]
    Number of new lesions T2 by MR at 24 months compared to the baseline.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Depression by Beck scale [ Time Frame: 24 months ]
    Evaluate mood disorders by means of Beck scale at 24 months compared to the baseline.
  • Fatigue by Krupp scale [ Time Frame: 24 months ]
    Evaluate fatigue by Krupp scale reported by the patients at 24 months compared to the baseline.
  • 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.
  • Visual field [ Time Frame: 24 months ]
    Change in visual field at 24 months compared to the baseline.
  • Volume of new T2 lesions [ Time Frame: 24 months ]
    Volume of size in T2 by MR at 24 months compared to the baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Progressive Multiple Sclerosis
  • Multiple Sclerosis, Secondary Progressive
Intervention  ICMJE
  • Drug: Andrographolides
    140 mg andrographolides coated tablets twice a day orally administered for 24 months.
    Other Names:
    • andrographolide, neoandrographolide, deoxyandrographolide
    • IB-MS 14
  • Drug: placebo
    140 mg excipients coated tablets twice a day orally administered for 24 months
Study Arms  ICMJE
  • Experimental: andrographolides
    Coated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months.
    Intervention: Drug: Andrographolides
  • Placebo Comparator: sugar tablets
    Coated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months.
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02273635
Other Study ID Numbers  ICMJE 14PIE-26946CORFO
14-391 ( Other Identifier: Comite Etico Cientifico - CEC MED UC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innobioscience SpA
Study Sponsor  ICMJE Innobioscience SpA
Collaborators  ICMJE
  • Pontificia Universidad Catolica de Chile
  • University of Chile
  • Universidad Austral de Chile
Investigators  ICMJE
Study Director: Juan L Hancke, DVM, PhD Universidad Austral de Chile
PRS Account Innobioscience SpA
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP