Clinical trial NCT05937802: Osmotin Plant Protein for Progressive Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Progressive Multiple Sclerosis
Keywords: Osmotin
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
Collaborators: name: Italian Multiple Sclerosis Foundation
name: S. Andrea Hospital
First posted: 2023-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of treatment-related adverse events after 1 month of therapy.
timeFrame: 1 month (after 1 month of treatment).
measure: Incidence and severity of treatment-related adverse events after 6 months of therapy.
timeFrame: 6 months (after 6 months of treatment).
Secondary outcomes:
measure: Change in Expanded Disability Status Scale (EDSS).
timeFrame: 12 months (6 month before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in Timed 25 Foot Walk (T25FW).
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in 12-item Multiple Sclerosis Walking Scale (MSWS12).
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in Nine-Hole Peg Test (9HPT).
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in Montreal Cognitive Assessment (MOCA).
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in Symbol Digit Modalities Test (SDMT).
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in patient self-evaluation of depression and anxiety recorded with Hospital Anxiety Depression Scale (HADS).
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in bladder domain function recorded with Overactive Bladder (OAB) questionnaire.
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: The impact of Forza™️ on neurophysiology in PMS.
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: The impact of Forza™️ on retinal atrophy in PMS.
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in serum neurofilament Light Chain (NfL) levels to verify the neuroprotective action of Forza™️ in PMS.
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in brain metabolism as concentration of glutamate, N-acetylaspartate, creatine and choline.
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
measure: Change in brain microstructure.
timeFrame: 12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Sant'Andrea
Study officials:
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