A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

Part of paid clinical trials in Palo Alto, California.

Sponsor
Minoryx Therapeutics, S.L.
Study ID
NCT05819866
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cerebral Adrenoleukodystrophy (cALD)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leriglitazone — DRUG
    Leriglitazone at a strength of 15 mg/ml. Once-daily dosing at an initial volume of 10 ml
  • Placebo — DRUG
    Placebo will match the study drug visually and by taste

Study Details

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.

Key Dates

Start date
Jul 12, 2023
Status verified
Nov 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Leriglitazone
    Leriglitazone Treatment
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo. [ Time Frame: Interim analysis 1 (at 18 months of treatment) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94304-5978
Jacinda Sampson
[email protected]
650-723-0993
Neuro Medicine Hospital / UF HealthGainesvilleFlorida32608-
Kennedy Krieger InstituteBaltimoreMaryland21205
Eric Mallack
[email protected]
443-923-2750
Massachusetts General HospitalBostonMassachusetts02114
Reza Seyedsadjadi
[email protected]
617-726-5175
University of MinnesotaMinneotaMinnesota55455
Troy Lund
[email protected]
612-625-4185
Health University of UtahSalt Lake CityUtah84112-

Find similar trials in Palo Alto, CA

By research site
Stanford University Medical Center· Palo Alto, CANeuro Medicine Hospital / UF Health· Gainesville, FLKennedy Krieger Institute· Baltimore, MDMassachusetts General Hospital· Boston, MAUniversity of Minnesota· Minneota, MNHealth University of Utah· Salt Lake City, UT

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