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

Herb Spirit

Status and phase: Withdrawn; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Spirit1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02588807

0015-14-CMC

Details and patient eligibility

About

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)

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Spirit1

Experimental group

Description:

Patients will take a daily nutritional supplement for 8 months

Treatment:

Drug: Spirit1