AN OPEN-LABEL STUDY OF ACUPOINT INJECTION THERAPY USING ENERCEL^® IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)

This is a preliminary, open-label trial of a homeopathic formulation, Enercel^®, which is to be administered IM, SL, SQ and orally in twenty patients with Amyotrophic Lateral Sclerosis (ALS).

The study subjects will be voluntary, adult participants who have a well-established diagnosis of ALS. Study participants will receive a standard Enercel^® treatment protocol. The study period will be six months followed by six months of monthly Quality-of-life (QOL) questionnaires.

Enercel^® will be given on the following schedule: 3cc intramuscularly once daily for the entire duration of the study. In addition, Enercel^® Max will be given 20 drops SL and 10 drops in 16 oz of water bid for the entire study. Finally, Enercel^® will be given subcutaneously at neurological acupuncture points (Acupoint injection therapy) 5-7 days per week (at the Acupuncturist’s discretion) for one month followed by treatments two times per week for the duration of the study. Active medication will be given for six months with a six month post-study follow-up.

Enercel^® is a homeopathic formulation that has been used safely and successfully in case-studies of multiple neurological disorders, including ALS. It appears to act primarily through enhancement of alternate energy (ACE) and perhaps other energy pathways in the body. It may improve intracellular energy in disorders characterized by defective cellular function, including the motor neurons in ALS. It has been shown to increase immune system function, a process that may be important in ALS given a potential association with a virus and/or immune system dysfunction. Enercel^® improves cellular metabolism and detoxification, which may be important in ALS if an environmental toxin exposure is important in its pathogenesis. Doses up to 50cc IV bid have been used without side-effects or toxicity.