Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS-PHL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02588807|
Recruitment Status : Suspended (The sponsor and hospital did not reach agreement)
First Posted : October 28, 2015
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: Spirit1||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||January 1, 2021|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||May 2022|
Patients will take a daily nutritional supplement for 8 months
Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Jacob Meer, MD||Carmel Medical Center|