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Osmotin Plant Protein for Progressive Multiple Sclerosis

Sponsor
Ospedale Policlinico San Martino (Other)
Overall Status
Recruiting
CT.gov ID
NCT05937802
Collaborator
Italian Multiple Sclerosis Foundation (Other), S. Andrea Hospital (Other)
50
Enrollment
2
Locations
1
Arm
24
Anticipated Duration (Months)
25
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name Forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (PMS). The potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (MRI) performed six months before starting treatment, at baseline, and after one and six months of treatment. At the same timepoints, electrophysiology, neurofilaments (NfL) quantification, optical coherence tomography (OCT) and clinical assessments will be performed.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Osmotin
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Exploratory Trial of Forza™️, a Novel Nutraceutical From Actinidia Deliciosa Plants Bioengineered to Bio-encapsulate the Osmotin Plant Protein as Adjuvant for the Treatment of Progressive Multiple Sclerosis
Actual Study Start Date :
Jan 2, 2023
Anticipated Primary Completion Date :
Jan 2, 2024
Anticipated Study Completion Date :
Jan 2, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Osmotin

Administration of a nutraceutical supplement provided in capsules, that consists of lyophilised and pulverised kiwi leaves from bioengineered kiwi (Actinidia Deliciosa) plants overexpressing the tobacco protein Osmotin.

Dietary Supplement: Osmotin
Oral administration for 6 months of 7 capsules per day (4 in the morning and 3 in the evening) for a daily dosage of 5 grams.
Other Names:
  • FORZA™️

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of treatment-related adverse events after 1 month of therapy. [1 month (after 1 month of treatment).]

    2. Incidence and severity of treatment-related adverse events after 6 months of therapy. [6 months (after 6 months of treatment).]

    Secondary Outcome Measures

    1. Change in Expanded Disability Status Scale (EDSS). [12 months (6 month before starting treatment, at baseline and both after one month and six months of treatment)]

      The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

    2. Change in Timed 25 Foot Walk (T25FW). [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Quantitative mobility and leg function performance test based on a timed 25-walk. T25FW improvement is ≥15% decrease in time from first record and worsening is ≥15% increase in time from first record.

    3. Change in 12-item Multiple Sclerosis Walking Scale (MSWS12). [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Self-reported measure of the impact of Multiple Sclerosis on the individual's walking ability. The scoring provides 1-5 for each of the 12 items, with 1 meaning no limitations and 5 meaning extreme limitation, for a maximum total score of 60. Then, this total score is transformed to a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.

    4. Change in Nine-Hole Peg Test (9HPT). [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Quantitative measure of upper extremity (arm and hand) function. 9HPT improvement is ≥15% decrease in time from first record and worsening is ≥15% increase in time from first record.

    5. Change in Montreal Cognitive Assessment (MOCA). [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Test to assesses different cognitive dimensions including attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. The lowest score that can be obtained from the scale is 0, and the highest score is 30. Higher scores indicate a better cognitive levels.

    6. Change in Symbol Digit Modalities Test (SDMT). [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Test to assess cognitive processes including memory, lexical access speed and information processing speed. The score is the number of correct answers in 90 seconds. The total score ranged from 0 to 110. Higher values represent better outcome.

    7. Change in patient self-evaluation of depression and anxiety recorded with Hospital Anxiety Depression Scale (HADS). [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Hospital Anxiety Depression Scale (HADS) is a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome. HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.

    8. Change in bladder domain function recorded with Overactive Bladder (OAB) questionnaire. [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Self-reported questionnaire to quantify Overactive Bladder symptoms including urgency, urination, frequent urination and feeling of urine at night and waking up. The scale consists of 8 items and answers are scored on a 6-level Likert scale. A maximum score of 40 can be obtained from the scale, and a score below 8 eliminates overactive bladder.

    9. The impact of Forza™️ on neurophysiology in PMS. [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), visual evoked potentials (VEPs) will be measured and compared pre and post treatment.

    10. The impact of Forza™️ on retinal atrophy in PMS. [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Optical Coherence Tomography (OCT) will be measured and compared pre and post treatment to assess the retinal thickness.

    11. Change in serum neurofilament Light Chain (NfL) levels to verify the neuroprotective action of Forza™️ in PMS. [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

    12. Change in brain metabolism as concentration of glutamate, N-acetylaspartate, creatine and choline. [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Proton magnetic resonance spectroscopy (1H-MRI) will be performed to quantify brain glutamate, N-acetylaspartate, creatine and choline.

    13. Change in brain microstructure. [12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)]

      Brain magnetic resonance imaging (MRI) will be performed with a multi-shell diffusion-weighted (DWI) sequence.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed written informed consent

    • Diagnosis of progressive multiple sclerosis (PMS)

    • Expanded Disability Status Scale EDSS ≤ 6.5

    Exclusion Criteria:

    • Contraindications to MRI

    • Pregnancy

    • HIV positivity

    • Severe renal, hepatic, oncological, hematological and psychiatric diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Ospedale Policlinico San Martino Genova Italy 16132
    2 Azienda Ospedaliera Universitaria Sant'Andrea Roma Italy 00189

    Sponsors and Collaborators

    • Ospedale Policlinico San Martino
    • Italian Multiple Sclerosis Foundation
    • S. Andrea Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Matilde Inglese, Clinical Professor, Principal Investigator, Ospedale Policlinico San Martino
    ClinicalTrials.gov Identifier:
    NCT05937802
    Other Study ID Numbers:
    • 12042
    First Posted:
    Jul 10, 2023
    Last Update Posted:
    Jul 10, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Matilde Inglese, Clinical Professor, Principal Investigator, Ospedale Policlinico San Martino
    Osmotin
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Chronic Progressive
    Sclerosis

    Study Results

    No Results Posted as of Jul 10, 2023