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ABBV-CLS-7262 for Vanishing White Matter Disease

Q: Are individuals able to enroll in this experimental procedure at present?

According to records on clinicaltrials.gov, the enrollment period for this study is still ongoing. The trial was initially posted on March 1st 2023 and recently modified six days ago.

Q: What is the extent of participation in this experiment?

Affirmative. On clinicaltrials.gov, there is evidence that this medical trial is actively seeking to include participants in its research. The trail was opened on March 1st 2023 and recently updated on the 6th of the same month. A total of 8 volunteers are needed between a single site for enrolment into the study.

Q: Has ABBV-CLS-7262 been endorsed by the FDA?

There is scarce clinical data available that indicates ABBV-CLS-7262's safety and efficacy, thus receiving a score of 1.

Phase 1 & 2

Recruiting

Research Sponsored by Calico Life Sciences LLC

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 baseline up to approximately week 100

Awards & highlights

Study Summary

This trial is studying a drug to treat a rare brain disorder. Subjects will have regular visits for 96 weeks to monitor safety and effectiveness.

Who is the study for?

Adults diagnosed with Vanishing White Matter disease, confirmed by a physician and MRI, who have a caregiver to assist them. Participants must be able to consent or have someone who can legally do so on their behalf. They should not have changed VWM medications in the last 4 weeks or received other investigational treatments recently. Adequate contraception is required for sexually active participants.Check my eligibility

What is being tested?

The trial tests ABBV-CLS-7262's safety and how the body processes it over a period of 96 weeks in patients with Vanishing White Matter disease. It's an open-label study, meaning everyone knows they're getting the drug, without any comparison group.See study design

What are the potential side effects?

Potential side effects are monitored through regular medical assessments and blood tests but are not specified here as this is an early phase trial investigating safety and tolerability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately week 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately week 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately week 100 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Plasma Concentration

Secondary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

3Treatment groups

Experimental Treatment

Group I: ABBV-CLS-7262 - Cohort 3Experimental Treatment1 Intervention

Cohort 3: VWM children ≥6 y and <12 years

Group II: ABBV-CLS-7262 - Cohort 2Experimental Treatment1 Intervention

Cohort 2: VWM children ≥12 y and <18 years

Group III: ABBV-CLS-7262 - Cohort 1Experimental Treatment1 Intervention

Cohort 1: VWM adults ≥18 years

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-CLS-7262

2023

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,376 Total Patients Enrolled

Calico Life Sciences LLCLead Sponsor

8 Previous Clinical Trials

944 Total Patients Enrolled

Media Library

ABBV-CLS-7262 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05757141 — Phase 1 & 2

Vanishing White Matter Disease Research Study Groups: ABBV-CLS-7262 - Cohort 3, ABBV-CLS-7262 - Cohort 2, ABBV-CLS-7262 - Cohort 1

Vanishing White Matter Disease Clinical Trial 2023: ABBV-CLS-7262 Highlights & Side Effects. Trial Name: NCT05757141 — Phase 1 & 2

ABBV-CLS-7262 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757141 — Phase 1 & 2

Frequently Asked Questions

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

Are individuals able to enroll in this experimental procedure at present?

"According to records on clinicaltrials.gov, the enrollment period for this study is still ongoing. The trial was initially posted on March 1st 2023 and recently modified six days ago."

Answered by AI

What is the extent of participation in this experiment?

"Affirmative. On clinicaltrials.gov, there is evidence that this medical trial is actively seeking to include participants in its research. The trail was opened on March 1st 2023 and recently updated on the 6th of the same month. A total of 8 volunteers are needed between a single site for enrolment into the study."

Answered by AI