Trials / Completed
CompletedNCT02306590
Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- University of Ulm · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Calogen | |
| DIETARY_SUPPLEMENT | Placebo |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2018-01-01
- Completion
- 2018-09-01
- First posted
- 2014-12-03
- Last updated
- 2019-02-26
Locations
11 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02306590. Inclusion in this directory is not an endorsement.