Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      After randomization, there is a placebo-controlled parallel group treatment with 10 mg OLN in
      combination with the standard treatment of Riluzole (100mg/day)(Group 1) in comparison to
      treatment with placebo in combination with 100 mg RIL (Group 2). Study drug will be provided
      as 5 mg tablets. OLN will be begun in an initial dosage of 5 mg/day for one week. The intake
      will occur in the evening hours in the form of a capsule containing 5 mg OLN. The evening
      dose of Riluzole can be taken together with the OLN medication. After one week (day 8), the
      dose will be increase to 10 mg OLN/day, which will be taken in the form of two capsules at
      the same timepoint in the evening hours. This dose will be continued for 51 weeks.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): Randomized, placebo-controlled, parallel group trial to evaluate the effectiveness and tolerability of an oral dose of 10 mg Olanzapine in combination with Riluzole for the treatment of Loss of Appetite in patients with amyotrophic lateral sclerosis (ALS)
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ALS; olanazapine; Loss of Apptetite; Appetite Loss; Malnutrition; Cachexia; Zyprexa