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CoA-Z for PKAN

N/A

Waitlist Available

Led By Penelope Hogarth, M.D.

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a possible new treatment for PKAN, to see if it is safe and effective.

Who is the study for?

This trial is for people with PKAN, a neurodegenerative condition. Participants can be from 3 months to 89 years old and must be able to take the study product orally or via feeding tube. They need a confirmed diagnosis of PKAN through genetic testing or brain imaging, live in North America, and commit to study procedures. Those on similar treatments within the last month or in another clinical trial are excluded.Check my eligibility

What is being tested?

The trial is testing CoA-Z against a placebo in individuals with PKAN. The goal is to determine if CoA-Z is safe, its effects on patients, and whether it alters disease measures. Participants will randomly receive either CoA-Z or an inactive substance (placebo) for comparison.See study design

What are the potential side effects?

While specific side effects of CoA-Z aren't listed here, common ones may include allergic reactions, gastrointestinal issues like nausea or diarrhea, headaches, fatigue, and potential interactions with other medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean percent of study product consumed.

Number of participants experiencing adverse events assessed by CTCAE v4.0

Number of participants experiencing clinically significant laboratory abnormalities on Complete Blood Count.

+5 more

Secondary outcome measures

Ratio of CoASY mRNA expression level to that of 18s, an internal control

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-label armExperimental Treatment1 Intervention

Up to 24 months of CoA-Z at dose 2

Group II: CoA-Z dose 3Experimental Treatment1 Intervention

6 months of CoA-Z at the lowest assigned dose followed by 18 months of CoA-Z at dose 2

Group III: CoA-Z dose 2Experimental Treatment1 Intervention

6 months of CoA-Z at the medium assigned dose followed by 18 months of CoA-Z at dose 2

Group IV: CoA-Z dose 1Experimental Treatment1 Intervention

6 months of CoA-Z at the highest assigned dose followed by 18 months of CoA-Z at dose 2

Group V: PlaceboPlacebo Group2 Interventions

6 months of placebo, followed by 18 months of CoA-Z at dose 2 (medium dose)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington State UniversityOTHER

101 Previous Clinical Trials

56,637 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,664 Total Patients Enrolled

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

6,845,952 Total Patients Enrolled

Media Library

CoA-Z (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04182763 — N/A

Neurodegeneration Research Study Groups: CoA-Z dose 3, Placebo, CoA-Z dose 1, CoA-Z dose 2, Open-label arm

Neurodegeneration Clinical Trial 2023: CoA-Z Highlights & Side Effects. Trial Name: NCT04182763 — N/A

CoA-Z (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04182763 — N/A

Frequently Asked Questions

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

Are applicants aged 85 or under being admitted to this investigation?

"This trial's eligibility criteria states that potential participants must between 3 months old to 89 years of age."

Answered by AI

How might I become an eligible participant in this research endeavor?

"This clinical trial is seeking 77 people aged 3 months to 89 years with a confirmed diagnosis of pantothenate kinase-associated neurodegeneration. The potential participants must meet the following criteria: having two pathogenic or likely pathogenic mutations, presenting typical symptoms and brain MR imaging findings as well as one pathogenic mutation plus/minus another likely pathogenic variation in PANK2; being willing and able to complete study procedures, telephone visits, and blood draws independently or have an assisting caregiver/parent; participating in the PKANready natural history study (eIRB 10832); residing within North America for the duration of the"

Answered by AI

Are any slots currently available in this experiment for volunteers?

"According to data posted on clinicaltrials.gov, this medical trial has concluded its recruitment process since the last editing date was January 25th 2022. Nonetheless, there are 7 other studies that require participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CoA-Z in Pantothenate Kinase-associated Neurodegeneration (PKAN)

Penelope Hogarth 2019. "CoA-Z in Pantothenate Kinase-associated Neurodegeneration (PKAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04182763.