patients with amyotrophic lateral sclerosis
Conditions
Interventions
Trade Name: Zyprexa
Pharmaceutical Form: Tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceuti
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age between 18 and 80 - diagnosis of ALS or ALS-variant PMA - sporadic or familial ALS - symptomatic with paresis for at least 6 months - stable treatment with Riluzol 100mg/die for at least 1 month - ability to communicate, personally or with the help of an authorized person - ability to communicate, verbally, manually or with an electronical communication system - patients agreement - no participation in an other clinical, medical trial during the treatment - the appetence, measured with Council of Nutrition appetite questionnaire Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - known hypersensivity to OLN, RIL or any excipient - clinical significant eating disorder - a wanted weight loss - an additional consumptive disease with unwanted weight loss - overweight BMI >= 25 kg/m2 - clinical significant hypotension or recurring syncopes - additional clinical severe diseases, including psychiatric diseases - pregnant or nursing women - women of childbearing age without highly effective contraception (defined as PEARL-Index 500 ms - treatment with cytochrome-P450-inhibitors - treatment with hepatotoxic drugs leading to a significant liver dysfunction - treatment with steroids or apetite-stimulating-drugs including anabolics during the last 3 months - diseases or dysfunctions, which exclude the patient from the trial in point of treating dotors view -lack of willingness to cooperate -any contraindication against olanzapine -existence of a percutaneous endoscopic gastrostomy -no approval of the storage and transfer of personal data even when using pseudonyms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: An appetite loss should be reduced through the appetite-increasing effect of olanzapine (OLN). The hypothesis states that the appetite-increasing effect in ALS patients during treatment with OLN 10mg in combination with Riluzol (RIL) 100mg is at least 17.5 percentage points higher than for treatment with placebo in combination with 100 mg RIL. ;Secondary Objective: Secondary objectives are: Does the treatment with olanzapin in patients with amyotrophic lateral sclerosis have an influence on: - the severity of the ALS,measured with the ALS-Functional Rating Scale - the survival time after beginning of paresis - the muscular strength, meassured with Manual Muscle Testing - the forced vital capacity - Body Mass Index (BMI) measured in body weight [kg]/(body length [m])2 - the number of patients needing a continous non-/invasive ventilation - the number of patients needing a PEG - the mortality after PEG placement - the occurence of pneumonia after PEG placement - the quality of sleep, meassured with Epworth Sleeping Scale – ESS - psychological factors, measured with Snaith-Hamilton-Plesure-Scale and Hospital Anxiety and Depression Scale ;Primary end point(s): The primary objective of the study is to evaluate the effectiveness of OLN in combination with RIL for ALS patients with appetite loss. | — |
Countries
Germany
Outcome results
None listed