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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Multip

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 Summary:

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 twi
   Sponsor: Innobioscience SpA
   

   Current 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.
   
   
   

   Original Primary Outcome: Same as current
   
   

   Current Secondary Outcome:

   • 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: Same as current
   
   Information By: Innobioscience SpA
   

   Dates:
   Date Received: October 3, 2014
   Date Started: September 2014
   Date Completion: April 2017
   Last Updated: October 24, 2014
   Last Verified: October 2014