Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS-PHL)

The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study

The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)

Study Overview

• Status: Withdrawn
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Drug: Spirit1

Detailed Description

This is an open label pilot study, where patients (n=10) with ALS will take a daily nutritional supplement for 8 months. After documenting the ALS symptom history at baseline, the disease severity, and the motor muscles functions will be assessed at baseline and every two months (0, 2 , 4, 6, 8 months of the treatment). Adverse events and side effect will be assessed on every visit and throughout the experiment. In addition, the level of renal function, liver function and electrolytes will be evaluated from blood samples taken at baseline, 4, and 8 months visits.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Hacarmel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males aged 18 to 75 years, Females>50 years
2. Diagnosis of "probable" or "definite" ALS according to the El Escorial revised criteria
3. A documented history of ALS symptoms for more than 6 month prior to study enrolment, and no more than 40 month.
4. Patients capable of understanding and signing Informed Consent.

Exclusion Criteria:

1. Patients allergic to seafood
2. Patients with forced vital capacity < 75%
3. Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow.
4. Patients with cardiovascular diseases
5. Patients with diabetes
6. Patients with active peptic ulcers
7. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
8. Patients suffering from other chronic significant disease, malignant diseases or any other disease that may risk the patient or interfere with the ability to interpret the results.
9. Patients that can not sign/understand the Informed Consent Form.
10. Female patients who are pregnant or lactating
11. Patients who have received and experimental drug or have participated in a clinical trial within 1 month prior to screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spirit1; Patients will take a daily nutritional supplement for 8 months	Drug: Spirit1; Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability and safety based on the number and severity of adverse events (AE)	Tolerability and safety evaluations will be based on the documentation of the incidence and severity of short term, and long term side effects, and adverse events (AEs) as well as changes in results of blood tests (increase in levels of liver enzymes, decrease in renal function, changes in complete blood count and electrolytes).	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)	The ALS-FRS-R is an instrument for evaluating the activities of daily living and global function of patients with ALS. It is used to monitor functional change in a patient over time and includes 12 questions. Each question has 5 possible responses (0-indicates unable to 4-indicates normal ability). Individual item scores are added to produce a reported score of between 0 = worst and 48 = best. A change of ≥25% is considered a clinically meaningful deterioration.	4, 8 months
Change from baseline in Forced vital capacity (FVC)	The purpose of this test is to assess the extent of respiratory muscle fatigue. The amount and/or speed (volume and flow respectively) of air that can be inhaled and exhaled will be measured by a commercial spirometer. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation.	2, 4, 6, 8 months
Change from baseline in hand grip power using a dynamometer	The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. The subject holds a commercial dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. When ready the patient will be asked to squeezes the dynamometer with maximum force which is maintained for 3 seconds. This will be repeated 3 times in each hand. The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort.	2, 4, 6, 8 months
Change from baseline in walking speed for 10 meters	The purpose of this test is to measure the lower extremities muscle strength. The patients will be asked to walk a distance of 10 meters in their maximal speed. The time to walk this distance will represent the lower extremities muscle strength.	2, 4, 6, 8 months

Collaborators and Investigators

• Sponsor: Herb Spirit
• Collaborators: Carmel Medical Center
• Investigators: Principal Investigator: Jacob Meer, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 0015-14-CMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No