Osmotin Plant Protein for Progressive Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT05937802 |
Recruitment Status :
Recruiting
First Posted : July 10, 2023
Last Update Posted : July 10, 2023
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Condition or disease | Intervention/treatment | Phase |
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Progressive Multiple Sclerosis | Dietary Supplement: Osmotin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | January 2, 2023 |
Estimated Primary Completion Date : | January 2, 2024 |
Estimated Study Completion Date : | January 2, 2025 |
Arm | Intervention/treatment |
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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.
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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 Name: FORZA™️ |
- Incidence and severity of treatment-related adverse events after 1 month of therapy. [ Time Frame: 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). ]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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) ]
- 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.
- 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.
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05937802
Contact: Matilde Inglese | 0103537028 ext +39 | m.inglese@unige.it |
Italy | |
IRCCS Ospedale Policlinico San Martino | Recruiting |
Genova, Italy, 16132 | |
Contact: Matilde Inglese, MD PhD 0103537028 ext +39 m.inglese@unige.it | |
Azienda Ospedaliera Universitaria Sant'Andrea | Recruiting |
Roma, Italy, 00189 | |
Principal Investigator: Marco Salvetti, MD |
Responsible Party: | Matilde Inglese, Clinical Professor, Principal Investigator, Ospedale Policlinico San Martino |
ClinicalTrials.gov Identifier: | NCT05937802 |
Other Study ID Numbers: |
12042 |
First Posted: | July 10, 2023 Key Record Dates |
Last Update Posted: | July 10, 2023 |
Last Verified: | June 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osmotin |
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Chronic Disease Disease Attributes |