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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Spirit1
Sponsored by
Herb Spirit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacarmel Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spirit1

Arm Description

Patients will take a daily nutritional supplement for 8 months

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 27, 2015
Last Updated
August 7, 2022
Sponsor
Herb Spirit
Collaborators
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02588807
Brief Title
Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis
Acronym
ALS-PHL
Official Title
The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor and hospital did not reach agreement
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herb Spirit
Collaborators
Carmel Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spirit1
Arm Type
Experimental
Arm Description
Patients will take a daily nutritional supplement for 8 months
Intervention Type
Drug
Intervention Name(s)
Spirit1
Intervention Description
Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants
Primary Outcome Measure Information:
Title
Tolerability and safety based on the number and severity of adverse events (AE)
Description
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).
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)
Description
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.
Time Frame
4, 8 months
Title
Change from baseline in Forced vital capacity (FVC)
Description
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.
Time Frame
2, 4, 6, 8 months
Title
Change from baseline in hand grip power using a dynamometer
Description
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.
Time Frame
2, 4, 6, 8 months
Title
Change from baseline in walking speed for 10 meters
Description
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.
Time Frame
2, 4, 6, 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males aged 18 to 75 years, Females>50 years Diagnosis of "probable" or "definite" ALS according to the El Escorial revised criteria A documented history of ALS symptoms for more than 6 month prior to study enrolment, and no more than 40 month. Patients capable of understanding and signing Informed Consent. Exclusion Criteria: Patients allergic to seafood Patients with forced vital capacity < 75% Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow. Patients with cardiovascular diseases Patients with diabetes Patients with active peptic ulcers Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc). 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. Patients that can not sign/understand the Informed Consent Form. Female patients who are pregnant or lactating Patients who have received and experimental drug or have participated in a clinical trial within 1 month prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Meer, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacarmel Hospital
City
Haifa
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis

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