Desipramine in Infantile Neuroaxonal Dystrophy (INAD).
NCT03726996 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2020-10-14
Summary
This is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children.
Participants will receive an initial oral dose of study drug once a day. This dose may be changed depending on response to study drug Clinically collected data will be recorded for up to 5 years. Investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care.
Conditions
- Infantile Neuroaxonal Dystrophy
Interventions
- DRUG
-
Desipramine
Study drug (desipramine) provided in tablet form to be taken daily.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Yong-hui Jiang, MD · Duke University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-14
- Primary Completion
- 2019-08-30
- Completion
- 2019-08-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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