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The primary objective of the trial is to investigate the survival time (the time from randomization until death or date of end of the study) compared between control group and experimental group.
This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Intervention | Experimental | High caloric fatty diet for drinking (100% lipids, 4.5 kcal/ml) 405 kcal/90 ml/day in addition to daily food intake and standard of care; corresponding to an additional intake of 45 g fat per day |
|
| Placebo | Placebo Comparator | Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calogen | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Survival in ALS-patients with study intervention compared to placebo | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of total ALS functional rating scale revised (ALSFRS-R) | 18 months | |
| Change of individual quality of life (SEIQoL) | 18 months | |
| Change of the slow vital capacity (sVC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert C. Ludolph, MD, Prof. | University Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University of Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany | ||
| Department of Neurology, University of Wuerzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34433481 | Derived | Witzel S, Frauhammer F, Steinacker P, Devos D, Pradat PF, Meininger V, Halbgebauer S, Oeckl P, Schuster J, Anders S, Dorst J, Otto M, Ludolph AC. Neurofilament light and heterogeneity of disease progression in amyotrophic lateral sclerosis: development and validation of a prediction model to improve interventional trials. Transl Neurodegener. 2021 Aug 26;10(1):31. doi: 10.1186/s40035-021-00257-y. |
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|
| 18 months |
| Time to tracheostomy or death (combined) | 18 months |
| Change of Body Mass Index (BMI) | 18 months |
| Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) | 18 months |
| Würzburg |
| Bavaria |
| 91054 |
| Germany |
| Department of Neurology, Medical School Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Department of Neurology, University of Rostock | Rostock | Mecklenburg-Vorpommern | D-18147 | Germany |
| Department of Neurology, TU Dresden | Dresden | Saxony | D-01307 | Germany |
| Department of Neurology, University of Halle-Wittenberg | Halle | Saxony-Anhalt | 06097 | Germany |
| Department of Neurology, University of Jena | Jena | Thuringia | D-07747 | Germany |
| Department of Neurology, Humboldt University | Berlin | 13353 | Germany |
| Neurologische Universitätsklinik Bergmannsheil | Bochum | 44789 | Germany |
| Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster | Münster | 48149 | Germany |
| Department of Neurology, DKD HELIOS Klinik | Wiesbaden | 65191 | Germany |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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