Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)
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|ClinicalTrials.gov Identifier: NCT00876772|
Recruitment Status : Unknown
Verified March 2011 by Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted : April 7, 2009
Last Update Posted : March 24, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: Olanzapine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Placebo-controlled Parallel Group Study for the Evaluation of an Oral Dose of 10mg Olanzapine in Combination With Riluzole for the Treatment of Loss of Appetite in Patients With Amyotrophic Lateral Sclerosis (ALS)|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||July 2012|
- Drug: Olanzapine
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)
- Self-evaluation of appetite by using the Council on Nutrition appetite questionnaire (CNAQ) [ Time Frame: 1 month ]
- Number and severity of adverse events (AE) and severe adverse events (SAE) [ Time Frame: 1 month ]
- Number of patients who have completed treatment with OLN in combination with RIL in comparison with placebo treatment in combination with RIL [ Time Frame: 1 month ]
- Body Mass Index (BMI) measured in body weight [kg]/(body length [m])2 [ Time Frame: 1 month ]
- Number of patients with a BMI <18.5 kg/m2 [ Time Frame: 1 month ]
- Median daily oral food intake in [kcal] which will be determined retrospectively and anamnestically by composing a dietary protocol and by conducting a standardized interview [ Time Frame: 1 month ]
- Median daily energy balance [kcal] (difference between actual food intake and target food intake)determined retrospectively and anamnestically by composing a dietary protocol and by conducting a standardized interview [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876772
|Contact: Thomas Meyer, MDfirstname.lastname@example.org|
|Contact: Teresa Holm, MDemail@example.com|
|Principal Investigator:||Thomas Meyer, MD||Charité University Hospital, Berlin, Germany|