Amyotrophic Lateral SclerosisNCT02306590
Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
A study testing Calogen in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 11 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Calogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 11 sitesGermany
- Study dates
- Feb 2015to Sep 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
- Disease duration < 36 months
- Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
- Age ≥18 years
- Continuously treated with 100 mg riluzole daily for at least four weeks
- Capable of thoroughly understanding all information given and giving full informed consent according to GCP
- Willing to complete a diet questionnaire throughout participation in the study
Who cannot join
- Simultaneous participation in another interventional clinical study
- Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
- Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
- Tracheostomy
- Patients with gastrostomy
- Pregnancy or breastfeeding
Show all 10Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Department of Neurology, Humboldt University
Berlin, 13353
Neurologische Universitätsklinik Bergmannsheil
Bochum, 44789
Department of Neurology, TU Dresden
Dresden, Saxony, D-01307
Department of Neurology, University of Halle-Wittenberg
Halle, Saxony-Anhalt, 06097
Department of Neurology, Medical School Hannover
Hanover, Lower Saxony, 30625
Department of Neurology, University of Jena
Jena, Thuringia, D-07747
Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster
Münster, 48149
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, D-18147
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081
Department of Neurology, DKD HELIOS Klinik
Wiesbaden, 65191
Department of Neurology, University of Wuerzburg
Würzburg, Bavaria, 91054
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Calogen, Placebo
- Keywords
- amyotrophic lateral sclerosis, survival time, ALS Functional Rating Scale, quality of life, survival
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalogenDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Calogen |
| Placebo | Placebo comparator | Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in ALS-patients with study intervention compared to placebo
Measured: 18 months
Secondary outcomes (6)
Change of total ALS functional rating scale revised (ALSFRS-R)
Measured: 18 months
Change of individual quality of life (SEIQoL)
Measured: 18 months
Change of the slow vital capacity (sVC)
Measured: 18 months
Time to tracheostomy or death (combined)
Measured: 18 months
Change of Body Mass Index (BMI)
Measured: 18 months
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Christian Ludolph, Prof., University of Ulm
- Investigators
- Albert C. Ludolph, MD, Prof., Principal investigator, University Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306590
- Sponsor's protocol ID
- LIPCAL-ALS
- Status last verified
- Feb 2019
- First submitted
- 1 Dec 2014
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34433481
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02306590
- Acronym / sponsor ID
- LIPCAL-ALS
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, survival time, ALS Functional Rating Scale, quality of life, survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Dietary Supplement: CalogenHigh 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 | Dietary Supplement: PlaceboPlacebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
- Disease duration < 36 months
- Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
- Age ≥18 years
- Continuously treated with 100 mg riluzole daily for at least four weeks
Key exclusion criteria (10 listed)
- Simultaneous participation in another interventional clinical study
- Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
- Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
- Tracheostomy
- Patients with gastrostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calogen | Dietary supplement | Study Intervention |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Survival in ALS-patients with study intervention compared to placebo
Time frame: 18 months
6 secondary outcomes
Change of total ALS functional rating scale revised (ALSFRS-R)
Time frame: 18 months
Change of individual quality of life (SEIQoL)
Time frame: 18 months
Change of the slow vital capacity (sVC)
Time frame: 18 months
Time to tracheostomy or death (combined)
Time frame: 18 months
Change of Body Mass Index (BMI)
Time frame: 18 months
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 34433481Witzel 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert C. Ludolph, MD, Prof. principal investigator
University Ulm
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calogen in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 11 sites 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 10 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Survival in ALS-patients with study intervention compared to placebo (time frame: 18 months). 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 NCT02306590, which also lists 1 linked publication.
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 26 Feb 2019.