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Ultra-high-caloric, Fatty Diet in ALS

Study acronym: LIPCAL-ALS II
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jan 1, 2028 → Apr 5, 2028
See other at-risk trials from University of Ulm

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Jun 1, 2024 to Jul 2, 2024 Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Primary and study completion pushed from Jan 1, 2028 to Apr 5, 2028
    • Enrollment target: estimated 392 to confirmed 399
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 4 of 16 entries
    • Study description revised
    • Site details revised at 23 of 23 sites
  2. Primary and study completion dates: Jun 1, 2027 to Jan 1, 2028v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 1, 2027 to Jun 1, 2027
    • Start date changed from estimate of May 1, 2024 to Jun 1, 2024
    • Study sites revised (23)
    v4
  4. Secondary endpoints: details revised at 2 of 16 entriesv3
  5. Secondary endpoints: details revised at 3 of 16 entriesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Ulm
31 trials monitored
See 1 trial at risk
ALS
398 trials monitored
See 21 trials at risk
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).
Trial Details
NCT Number NCT06280079
Lead Sponsor University of Ulm
Conditions
(from sponsor)		 Amyotrophic Lateral Sclerosis
Related terms Amyotrophic Lateral Sclerosis
Enrollment 399 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov