Amyotrophic Lateral Sclerosis Clinical Trial
— LIPCAL-ALS IIOfficial title:
Efficacy, Safety, and Tolerability of Ultra-high-caloric, Fatty Diet (UFD) in Amyotrophic Lateral Sclerosis (ALS)
This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).
Status | Not yet recruiting |
Enrollment | 392 |
Est. completion date | May 1, 2027 |
Est. primary completion date | May 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria - Disease duration (onset of first paresis or bulbar symptoms) < 24 months - Loss of amyotrophic lateral sclerosis functional rating scale revised of = 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit) - Age =18 years. - Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion - Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion - Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion - Capable of thoroughly understanding all information given - full written informed consent according to good clinical practice Exclusion Criteria: - Previous participation in another interventional study involving an active treatment within the preceding 4 weeks - Tracheostomy or continuous permanent ventilator dependence (>22 hours per day) - Pregnancy or breastfeeding - Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS - Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. - Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. - Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency |
Country | Name | City | State |
---|---|---|---|
Germany | RWTH Aachen | Aachen | |
Germany | Charité Universitätsmedizin Berlin | Berlin | |
Germany | University Clinic Bochum | Bochum | |
Germany | University Clinic Bonn | Bonn | |
Germany | Technical University Dresden | Dresden | |
Germany | University Clinic Erlangen | Erlangen | |
Germany | Alfried Krupp Krankenhaus Essen | Essen | |
Germany | University Clinic Göttingen | Göttingen | |
Germany | University Clinic Halle | Halle | |
Germany | Hannover Medical School | Hannover | |
Germany | University Clinic Jena | Jena | |
Germany | DRK Clinic Kassel | Kassel | |
Germany | Klinikum Kempten | Kempten | |
Germany | University Clinic Leipzig | Leipzig | |
Germany | University Clinic Lübeck | Lübeck | |
Germany | University Clinic Mannheim | Mannheim | |
Germany | Technical University Munich | Munich | |
Germany | University Clinic Münster | Münster | |
Germany | University Clinic Regensburg | Regensburg | |
Germany | University Clinic Rostock | Rostock | |
Germany | University of Ulm | Ulm | |
Germany | DKD HELIOS Clinic Wiesbaden | Wiesbaden | |
Germany | University Clinic Würzburg | Würzburg |
Lead Sponsor | Collaborator |
---|---|
University of Ulm |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microtubule-associated protein 2 in serum | change of Microtubule-associated protein 2 levels in serum compared to baseline | 18 months | |
Other | Microtubule-associated protein 2 in cerebrospinal fluid | change of microtubule-associated protein 2 levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | Ubiquitin carboxy-terminal hydrolase L1 in serum | change of ubiquitin carboxy-terminal hydrolase L1 levels in serum compared to baseline | 18 months | |
Other | Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid | change of ubiquitin carboxy-terminal hydrolase L1 levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | Transmembrane glycoprotein NMB in serum | change of transmembrane glycoprotein NMB levels in serum compared to baseline | 18 months | |
Other | Transmembrane glycoprotein NMB in cerebrospinal fluid | change of transmembrane glycoprotein NMB levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | Human cartilage glycoprotein 39 in serum | change of human cartilage glycoprotein 39 levels in serum compared to baseline | 18 months | |
Other | Human cartilage glycoprotein 39 in cerebrospinal fluid | change of human cartilage glycoprotein 39 levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | SNAP-25 in serum | change of SNAP-25 levels in serum compared to baseline | 18 months | |
Other | SNAP-25 in cerebrospinal fluid | change of SNAP-25 levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | Beta-synuclein in serum | change of beta-synuclein levels in serum compared to baseline | 18 months | |
Other | Beta-synuclein in cerebrospinal fluid | change of beta-synuclein levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | Aquaporin-4 in serum | change of aquaporin-4 levels in serum compared to baseline | 18 months | |
Other | Aquaporin-4 in cerebrospinal fluid | change of aquaporin-4 levels in cerebrospinal fluid compared to baseline | 18 months | |
Other | Glial fibrillary acidic protein in serum | change of glial fibrillary acidic protein levels in serum compared to baseline | 12 months | |
Other | Glial fibrillary acidic protein in cerebrospinal fluid | change of glial fibrillary acidic protein levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | Soluble triggering receptor expressed on myeloid cell-1 in serum | change of soluble triggering receptor expressed on myeloid cell-1 levels in serum compared to baseline | 12 months | |
Other | Soluble triggering receptor expressed on myeloid cell-1 in cerebrospinal fluid | change of soluble triggering receptor expressed on myeloid cell-1 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | CC-chemokine ligand 2 in serum | change of CC-chemokine ligand 2 levels in serum compared to baseline | 12 months | |
Other | CC-chemokine ligand 2 in cerebrospinal fluid | change of CC-chemokine ligand 2 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-1b in serum | change of interleukin-1b levels in serum compared to baseline | 12 months | |
Other | interleukin-1b in cerebrospinal fluid | change of interleukin-1b levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-2 in serum | change of interleukin-2 levels in serum compared to baseline | 12 months | |
Other | interleukin-2 in cerebrospinal fluid | change of interleukin-2 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-4 in serum | change of interleukin-4 levels in serum compared to baseline | 12 months | |
Other | interleukin-4 in cerebrospinal fluid | change of interleukin-4 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-6 in serum | change of interleukin-6 levels in serum compared to baseline | 12 months | |
Other | interleukin-6 in cerebrospinal fluid | change of interleukin-6 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-10 in serum | change of interleukin-10 levels in serum compared to baseline | 12 months | |
Other | interleukin-10 in cerebrospinal fluid | change of interleukin-10 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-12p70 in serum | change of interleukin-12p70 levels in serum compared to baseline | 12 months | |
Other | interleukin-12p70 in cerebrospinal fluid | change of interleukin-12p70 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | interleukin-17 in serum | change of interleukin-17 levels in serum compared to baseline | 12 months | |
Other | interleukin-17 in cerebrospinal fluid | change of interleukin-17 levels in cerebrospinal fluid compared to baseline | 12 months | |
Other | Tumor necrosis factor alpha in serum | change of tumor necrosis factor alpha levels in serum compared to baseline | 12 months | |
Other | Tumor necrosis factor alpha in cerebrospinal fluid | change of tumor necrosis factor alpha levels in cerebrospinal fluid compared to baseline | 12 months | |
Primary | Survival | Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (>22 hours per day) | 18 months | |
Secondary | Amyotrophic Lateral Sclerosis Functional Rating Scale Revised | Change per month of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised | 18 months | |
Secondary | Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale | Change per month of Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale | 18 months | |
Secondary | Individual Quality of Life | Change of Euro Quality of Life 5D 5L (EQ-5D-5L) compared to baseline | 18 months | |
Secondary | Slow vital capacity | Change of slow vital capacity compared to baseline | 18 months | |
Secondary | Survival | Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (>22 hours per day) | 6 months | |
Secondary | Survival | Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (>22 hours per day) | 12 months | |
Secondary | Time to death | Time from date of randomization until date of death | 18 months | |
Secondary | Time to tracheostomy | Time from date of randomization until date of tracheostomy | 18 months | |
Secondary | Time to permanent continous ventilator dependence | Time from date of randomization to permanent continous ventilator dependence (>22 hours per day) | 18 month | |
Secondary | Ventilation assistance-free survival | Time from date of randomization until implementation of mechanical ventilation | 18 months | |
Secondary | Body Mass Index | Change of body mass index compared to baseline | 18 months | |
Secondary | Council of Nutrition Appetite Questionnaire | Change of Council of Nutrition Appetite Questionnaire sum score compared to baseline | 18 months | |
Secondary | Eating Habits | Change of Ulm Nutrition Questionnaire compared to baseline; qualitative changes on a descriptional level (the questionnaire has no sum score); the score is meant to detect changes of eating habits and has been used in the precursor study LIPCAL-ALS I (see doi: 10.1002/ana.25661). | 18 months | |
Secondary | Neurofilament light chain | Change of neurofilament light chain serum levels compared to baseline | 18 months | |
Secondary | Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model | Difference between observed and predicted decrease of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (measured as points lost per month), based on the a prediction model, which estimates disease progression based on neurofilament light chain serum baseline levels | 18 months | |
Secondary | Neurofilament Assess Score | Difference between observed and predicted survival based on the Neurofilament Assess Score, a score estimating survival based on the neurofilament light chain serum baseline levels | 18 months |
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