Osmotin Plant Protein for Progressive Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Progressive Multiple Sclerosis
• Interventions: Dietary Supplement: Osmotin

• Registration Number: NCT05937802
• Lead Sponsor: Ospedale Policlinico San Martino

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Study First Submitted: 2023-05-22
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Primary Completion: 2024-01-02
• Study Completion: 2025-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Osmotin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (2)

Azienda Ospedaliera Universitaria Sant'Andrea; 🇮🇹 Roma, Italy

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy