Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis

NCT02588807 | Withdrawn Phase 1

• 1 other identifier: 0015-14-CMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)

  4, 8 months

• Change from baseline in Forced vital capacity (FVC)

  2, 4, 6, 8 months

• Change from baseline in hand grip power using a dynamometer

  2, 4, 6, 8 months

• Change from baseline in walking speed for 10 meters

  2, 4, 6, 8 months

Study Arms (1)

Spirit1

EXPERIMENTAL

Patients will take a daily nutritional supplement for 8 months

Drug: Spirit1

Interventions

Spirit1 DRUG

Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants

Spirit1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Herb Spirit: lead
• Carmel Medical Center: collaborator

Study Sites (1)

Hacarmel Hospital

Haifa, Israel

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jacob Meer, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

IL (1)