Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a
selective degeneration of the motor nerve cells in the cortex and myelon. As a result of
motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,
swallowing, and breathing musculature develops. ALS leads to death by respiratory
insufficiency in a mean course of 3-5 years. More than 80% of ALS patients present with a
clinically significant and undesirable weight loss. The cause of weight loss is
heterogeneous. Fundamentally, the investigators must distinguish malnutrition, cachexia and
loss of appetite. Loss of weight is an independent prognosis factor in ALS. Effective
treatment of undesirable weight loss is an important therapy goal for ALS.
The researchers propose an investigational therapy of ALS with oral administration of
Olanzapine. The rationale for this study is based on the weight-increasing effect of OLN. The
clinical trial aims to employ OLN-induced weight gain or weight stabilization as a
symptomatic therapy for the loss of appetite. An undesired weight loss of at least 10% of the
body weight should be reduced through the weight-increasing effect of OLN. The hypothesis
states that the undesired weight loss in ALS patients during treatment with OLN 10mg in
combination with Riluzole (RIL) 100mg is at least 20 percentage points less than for
treatment with placebo in combination with 100 mg RIL.