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

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ClinicalTrials.gov Identifier: NCT02588807
Recruitment Status : Not yet recruiting
First Posted : October 28, 2015
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Carmel Medical Center
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Spirit1 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : May 2019


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




Primary Outcome Measures :
  1. Tolerability and safety based on the number and severity of adverse events (AE) [ Time Frame: 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 :
  1. Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr) [ Time Frame: 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.


  2. Change from baseline in Forced vital capacity (FVC) [ Time Frame: 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.

  3. Change from baseline in hand grip power using a dynamometer [ Time Frame: 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.

  4. Change from baseline in walking speed for 10 meters [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02588807


Contacts
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Contact: Jacob Meer, MD +972-4-8250390 jakobme@clalit.org.il
Contact: Jusri Zuabi, MD +972-4-8250390

Sponsors and Collaborators
Herb Spirit
Carmel Medical Center
Investigators
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Principal Investigator: Jacob Meer, MD Carmel Medical Center

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Responsible Party: Herb Spirit
ClinicalTrials.gov Identifier: NCT02588807     History of Changes
Other Study ID Numbers: 0015-14-CMC
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases