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NCT04270682 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)

A Phase 3 study, sponsored by Mirum Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
19
Enrollment target

NCT04270682 is a Phase 3 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 19 participants.

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The verdict

NCT04270682, a Phase 3 study, has completed, sponsored by Mirum Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
19 participants
Enrollment target

Study Summary

The study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1 month and \<16 years of age (pediatric cohort)

Interventions

  • DRUG Placebo
  • DRUG Blinded CDCA 250 mg TID
  • DRUG Open-Label CDCA 250 mg TID
  • DRUG Rescue Medication CDCA 250 mg TID
  • DRUG CDCA Weight-Based Dose TID

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2020-01-31
Est. Completion 2023-10-04
Phase Phase 3

Sponsor

Mirum Pharmaceuticals

28 total trials

What the Registry Record Tells You About NCT04270682

The ClinicalTrials.gov registry entry for NCT04270682 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT04270682 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04270682 about?

NCT04270682 is a clinical study titled "Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)". The study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1 month and \<16 years of age (pediatric cohort)

What is the current status of trial NCT04270682?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2020-01-31. Estimated completion is 2023-10-04.

What interventions are being tested in trial NCT04270682?

The interventions under investigation include: Placebo (DRUG), Blinded CDCA 250 mg TID (DRUG), Open-Label CDCA 250 mg TID (DRUG), Rescue Medication CDCA 250 mg TID (DRUG), CDCA Weight-Based Dose TID (DRUG).

Who is sponsoring clinical trial NCT04270682?

This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.