Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis

Phase 1

Withdrawn

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Spirit1

• Registration Number: NCT02588807
• Lead Sponsor: Herb Spirit

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.

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2021-01-01
• Primary Completion: 2021-09
• Study Completion: 2022-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-07
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spirit1	Spirit1	Patients will take a daily nutritional supplement for 8 months

Primary Outcome Measures

Name	Time	Method
Tolerability and safety based on the number and severity of adverse events (AE)	8 months	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

Name	Time	Method
Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)	4, 8 months	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)	2, 4, 6, 8 months	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	2, 4, 6, 8 months	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	2, 4, 6, 8 months	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.

Trial Locations

Locations (1)

Hacarmel Hospital; 🇮🇱 Haifa, Israel