Clinical trial: Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS) (NCT00876772)

Eligibility criteria:
Inclusion Criteria:

          -  Patients between the ages of 18 and 80 years old

          -  Clinical diagnosis of definitive, probable, and possible ALS (revised El Escorial
             Criteria) or diagnosis of the clinical ALS-variants of Progressive Muscle Atrophy
             (PMA)

          -  Sporadic and familial ALS

          -  Beginning of symptoms of paralysis at least 6 months prior

          -  Treatment with a steady dose of RIL 100 mg/day for at least 1 month

          -  A score of ≤ 28 in the symptom-oriented Council on Nutrition appetite questionnaire
             (CNAQ) by which appetite is evaluated

          -  Patient consent

        Exclusion Criteria:

          -  Patients with known hypersensitivity to OLN, RIL, or one of the active ingredients

          -  Percutaneous Endoscopic Gastronomy (PEG)

          -  Clinically significant eating disorder

          -  Deliberate weight loss

          -  Underlying consumptive disease with undesired weight loss

          -  Overweight with BMI ≥ 25 kg/m2

          -  Clinically significant hypotonia and history of recurrent syncopes (> 1 syncope)

          -  Clinically severe concomitant illnesses, including psychiatric illnesses

          -  Pregnant or nursing women

          -  Severe neutropenia (< 750/mm3)

          -  Open angle glaucoma

          -  Diabetes mellitus

          -  Prostatic hyperplasia

          -  Extrapyramidal movement disorders including from late dyskinesia

          -  Dementia and incompetence to grant informed consent

          -  Clinically significant EKG changes

          -  EKG proof of a QT time corrected according to Fridericia (QTcF) > 500 ms

          -  Treatment with substances that are metabolized by the Cytochrom-P450-System CYP1A2 (e.
             g. Carbamazepine, Fluvoxamin, and Ciprofloxacin)

          -  Treatment with Mirtazapine within the past 3 months

          -  Treatment with steroids or appetite-stimulating substances including anabolics within
             the past 3 months

          -  Treatment with Valproat within the past 3 months

          -  Treatment with hepatotoxic medicines

          -  Treatment with tetrahydrocannabinol within the past 3 months

          -  Treatment with another atypical or typical neuroleptic within the past 3 months

          -  Treatment with any other study medication < 1 month before the beginning of the study

          -  Destructive use of psychotropic substances within the past 3 months

          -  Destructive use of alcohol

          -  Laboratory parameters outside the normal range that are associated with a clinically
             significant cardiovascular, pulmonologic, hematologic, hepatological, metabolic, or
             renal disease or that interfere with interpretation of the clinical study or that
             require medications that are not permitted in the study protocol

          -  Elevation of the serum transaminase levels (ALT/AST) to more than 3-times of the upper
             normal value

          -  Elevation of the bilirubin and gamma glutamyl transferase levels (GGT) to beyond the
             maximum normal value

          -  History of a cardiopulmonary reanimation und prevention of sudden cardiac death

          -  History of clinically significant EKG changes

          -  History of thrombotic events including deep leg vein thrombosis and pulmonary artery
             embolism

          -  History of a paralytic ileus

          -  History of epilepsy or an episodic seizure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? 1