Natural History Study of Patients With Canavan Disease (CANinform Study)

NCT ID: NCT04126005

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-10

Study Completion Date

2025-07-31

Brief Summary

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This study uses medical records that allow retrospective data extraction of critical milestone and motor function data. In addition, prospective assessments collect data relevant to the natural history of Canavan disease in children.

Detailed Description

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The CANinform natural history study is the first multinational effort to rigorously gather both retrospective and prospective data from this patient population. Data collection includes extraction of retrospective data from medical records of living and deceased patients, and collection of prospective, longitudinal data from living patients and their parent(s)/caregiver(s). Motor function assessments are performed remotely in the home via video or in the clinic by qualified study team members. Families will be invited to attend clinic visits and/or will be followed remotely by the clinical site for approximately 3 years.

Conditions

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Canavan Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1 (Age < 18 Months)

* Motor function assessments (remote or in-clinic) every 2 months
* Clinic assessments every 6 months

No interventions assigned to this group

Cohort 2 (Age ≥ 18 Months - 3 Years)

* Motor function assessments (remote or in-clinic) every 4 months
* Clinic assessments every 6 months

No interventions assigned to this group

Cohort 3 (Age > 3 - 5 Years)

* Motor function assessments (remote or in-clinic) every 6 months
* Clinic assessments every 6 months

No interventions assigned to this group

Cohort 4 (Age > 5 Years)

* Motor function assessments (remote or in-clinic) 12 months
* Clinic assessments every 12 months

No interventions assigned to this group

Cohort 5 (Deceased)

• The patient's medical history records will be reviewed. In addition, a parent interview will be performed.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Meet age criteria of a specific cohort.
2. Confirmed clinical and biochemical diagnosis of Canavan disease.
3. Available medical records since birth that permit documentation of disease characteristics and developmental milestones.
4. Parent and/or legal guardian is able to read, understand, and sign the informed consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aspa Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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United States Germany

Related Links

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http://aspatx.com

Aspa Therapeutics Company Website

http://treatcanavan.com

CANinform Study Website

Other Identifiers

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CANinform

Identifier Type: OTHER

Identifier Source: secondary_id

CVN-101

Identifier Type: -

Identifier Source: org_study_id

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