Osmotin Plant Protein for Progressive Multiple Sclerosis

NCT05937802 | Unknown

• 1 other identifier: 12042
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Progressive Multiple Sclerosis

Keywords

Osmotin

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment-related adverse events after 1 month of therapy.

  1 month (after 1 month of treatment).

• Incidence and severity of treatment-related adverse events after 6 months of therapy.

  6 months (after 6 months of treatment).

Secondary Outcomes (13)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Osmotin

EXPERIMENTAL

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

Interventions

Osmotin DIETARY_SUPPLEMENT

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.

Also known as: FORZA™️

Osmotin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Diagnosis of progressive multiple sclerosis (PMS)
• Expanded Disability Status Scale EDSS ≤ 6.5

You may not qualify if:

• Contraindications to MRI
• Pregnancy
• HIV positivity
• Severe renal, hepatic, oncological, hematological and psychiatric diseases

Sponsors & Collaborators

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

Study Sites (2)

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Sant'Andrea

Roma, 00189, Italy

RECRUITING

Related Publications (30)

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  PMID: 40014609 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matilde Inglese

CONTACT

0103537028; m.inglese@unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 10, 2023
• Study Start: January 2, 2023
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2025
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

IT (2)