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NCT02829268 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome
A Phase 1 study of Diabetes Mellitus and Ataxia, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02829268: Completed Phase 1 study of Diabetes Mellitus and Ataxia, sponsored by Washington University School of Medicine.
NCT02829268 is a Phase 1 study of Diabetes Mellitus and Ataxia that has completed, run by Washington University School of Medicine. The registered enrollment target is 21 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02829268, a Phase 1 study of Diabetes Mellitus and Ataxia, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical \& medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
Primary Outcome
The investigators assess the safety and tolerability of dantrolene sodium administered orally at upper end of therapeutic dose range for 6 months in patients with Wolfram syndrome. More specifically, the investigators perform liver function tests to check the levels of certain enzymes and proteins in participants' blood. Levels that are higher or lower than normal can indicate liver problems. The liver function tests include: Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline Ph
Conditions Studied
Interventions
- DRUG dantrolene sodium
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-01 |
| Est. Completion | 2023-02 |
| Phase | Phase 1 |
What the finished NCT02829268 record still lists
NCT02829268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which dantrolene sodium is the first listed.
NCT02829268 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02829268 about?
NCT02829268 is a clinical study titled "A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome". Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In a...
What is the current status of trial NCT02829268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-01. Estimated completion is 2023-02.
What conditions does trial NCT02829268 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Ataxia, Wolfram Syndrome, Optic Nerve Atrophy.
What interventions are being tested in trial NCT02829268?
The interventions under investigation include: dantrolene sodium (DRUG).
Who is sponsoring clinical trial NCT02829268?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02829268 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02829268's enrollment target sits among peer trials
21 194th of 208 higher than 15 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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