Osmotin Plant Protein for Progressive Multiple Sclerosis

June 30, 2023 updated by: Matilde Inglese, Ospedale Policlinico San Martino

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
      • Roma, Italy, 00189
        • Recruiting
        • Azienda Ospedaliera Universitaria Sant'Andrea
        • Principal Investigator:
          • Marco Salvetti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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™️

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment-related adverse events after 1 month of therapy.
Time Frame: 1 month (after 1 month of treatment).
1 month (after 1 month of treatment).
Incidence and severity of treatment-related adverse events after 6 months of therapy.
Time Frame: 6 months (after 6 months of treatment).
6 months (after 6 months of treatment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Expanded Disability Status Scale (EDSS).
Time Frame: 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.
12 months (6 month before starting treatment, at baseline and both after one month and six months of treatment)
Change in Timed 25 Foot Walk (T25FW).
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in 12-item Multiple Sclerosis Walking Scale (MSWS12).
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in Nine-Hole Peg Test (9HPT).
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in Montreal Cognitive Assessment (MOCA).
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in Symbol Digit Modalities Test (SDMT).
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in patient self-evaluation of depression and anxiety recorded with Hospital Anxiety Depression Scale (HADS).
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in bladder domain function recorded with Overactive Bladder (OAB) questionnaire.
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
The impact of Forza™️ on neurophysiology in PMS.
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
The impact of Forza™️ on retinal atrophy in PMS.
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in serum neurofilament Light Chain (NfL) levels to verify the neuroprotective action of Forza™️ in PMS.
Time Frame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in brain metabolism as concentration of glutamate, N-acetylaspartate, creatine and choline.
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Change in brain microstructure.
Time Frame: 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.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Policlinico San Martino

Collaborators

Italian Multiple Sclerosis Foundation
S. Andrea Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Estimated)

January 2, 2024

Study Completion (Estimated)

January 2, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12042 (Registry Identifier: DAIDS-ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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