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Amyotrophic Lateral Sclerosis (ALS)Phase 2/3NCT00876772

Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)

A Phase 2/3 study testing Olanzapine in people with Amyotrophic Lateral Sclerosis (ALS), run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Amyotrophic Lateral Sclerosis (ALS)
What is being tested?
Olanzapine
Type of treatment
Pill or oral medicine
How many people
40 participants
Where
1 siteGermany
Study dates
Mar 2011to Jul 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 35Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin, Berlin, Germany

    Berlin, 13353

Other trials in Germany

About this study

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)

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.

Read the 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.

Being tested
Olanzapine
Keywords
ALS, olanazapine, Loss of Apptetite, Appetite Loss, Malnutrition, Cachexia, Zyprexa
Medical subject headings
Amyotrophic Lateral Sclerosis, Anorexia, Malnutrition, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlanzapineDrug

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-evaluation of appetite by using the Council on Nutrition appetite questionnaire (CNAQ)

    Measured: 1 month

Secondary outcomes (6)

  1. Number and severity of adverse events (AE) and severe adverse events (SAE)

    Measured: 1 month

  2. Number of patients who have completed treatment with OLN in combination with RIL in comparison with placebo treatment in combination with RIL

    Measured: 1 month

  3. Body Mass Index (BMI) measured in body weight [kg]/(body length [m])2

    Measured: 1 month

  4. Number of patients with a BMI <18.5 kg/m2

    Measured: 1 month

  5. 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

    Measured: 1 month

  6. 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

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2009 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876772
Sponsor's protocol ID
OLN-ALS01
Status last verified
Feb 2024
First submitted
6 Apr 2009
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Olanzapine in people with Amyotrophic Lateral Sclerosis (ALS), run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-evaluation of appetite by using the Council on Nutrition appetite questionnaire (CNAQ) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00876772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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