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Diet + Lovastatin + Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis

Phase 2

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosi

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study patients with cerebrotendinous xanthomatosis to see the effects of a cholesterol- and cholestanol-free diet, and the drugs lovastatin and chenodeoxycholic acid, on the biosynthesis of cholesterol and cholestanol, and the turnover of individual sterols and bile acids.

Who is the study for?

This trial is for patients who have been diagnosed with cerebrotendinous xanthomatosis, a rare condition affecting cholesterol and bile acid metabolism. Participants need to follow a special diet free from cholesterol and cholestanol.Check my eligibility

What is being tested?

The study aims to see how a diet without cholesterol and cholestanol, along with medications lovastatin and chenodeoxycholic acid, affects the body's production of these substances in people with cerebrotendinous xanthomatosis.See study design

What are the potential side effects?

Potential side effects may include muscle pain or weakness due to lovastatin, as well as digestive issues like stomach pain or constipation from both treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

317,011 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

974 Previous Clinical Trials

7,385,907 Total Patients Enrolled

William ConnorStudy ChairOregon Health and Science University

2 Previous Clinical Trials

105 Total Patients Enrolled

Media Library

Cholesterol- and Cholestanol-Free Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00004346 — Phase 2

Cerebrotendinous Xanthomatosis Research Study Groups:

Cerebrotendinous Xanthomatosis Clinical Trial 2023: Cholesterol- and Cholestanol-Free Diet Highlights & Side Effects. Trial Name: NCT00004346 — Phase 2

Cholesterol- and Cholestanol-Free Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004346 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks and side effects of this medication?

"There is only some data supporting the safety of this treatment, as it has only been tested in a Phase 2 trial. This means that there are no efficacy data to support its use."

Answered by AI

Could you share the age requirements for this clinical trial?

"This trial is open to any age, as both the minimum and maximum age limit for participants is 0."

Answered by AI

Are there any available positions for candidates in this research program?

"As of now, this clinical trial is not recruiting patients. The last time it was updated was on June 23rd, 2005, although it was originally posted on January 1st, 1996. Although this particular trial isn't looking for participants, there are 3 other trials that are."

Answered by AI

For whom would this particular clinical trial be a good fit?

"The ideal candidate for this clinical trial would be a 0 year old suffering from xanthomatosis and cerebrotendinous. Only 5 patients are needed for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis

1996. "Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00004346.

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