Clinical trial NCT02588807: Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis
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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Herb Spirit
Sponsor class: INDUSTRY
Collaborators: name: Carmel Medical Center
First posted: 2015-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Tolerability and safety based on the number and severity of adverse events (AE)
timeFrame: 8 months
Secondary outcomes:
measure: Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)
timeFrame: 4, 8 months
measure: Change from baseline in Forced vital capacity (FVC)
timeFrame: 2, 4, 6, 8 months
measure: Change from baseline in hand grip power using a dynamometer
timeFrame: 2, 4, 6, 8 months
measure: Change from baseline in walking speed for 10 meters
timeFrame: 2, 4, 6, 8 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Hacarmel Hospital
Study officials:
affiliation: Carmel Medical Center
name: Jacob Meer, MD
role: PRINCIPAL_INVESTIGATOR
References: