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NCT01399047 · ClinicalTrials.gov registry record · Phase 2
Cellcept for Treatment of Juvenile Neuronal Ceroid Lipofuscinosis
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01399047 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 19 participants.
The verdict
NCT01399047, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary objective of this trial is to establish the safety and tolerability of short-term (8 weeks) administration of mycophenolate mofetil in ambulatory children with JNCL. The secondary objective is to gather preliminary evidence of the short-term (8 week) impact of mycophenolate mofetil on clinically relevant features of JNCL as measured by the Unified Batten Disease Rating Scale (UBDRS), including motor features, seizures, behavior, cognitive and functional measures. Funding source-FDA Office of Orphan Product Development (OOPD).
Interventions
- DRUG Mycophenolate mofetil
- DRUG Liquid Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01399047
The ClinicalTrials.gov registry entry for NCT01399047 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mycophenolate mofetil is the first listed.
NCT01399047 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01399047 about?
NCT01399047 is a clinical study titled "Cellcept for Treatment of Juvenile Neuronal Ceroid Lipofuscinosis". The primary objective of this trial is to establish the safety and tolerability of short-term (8 weeks) administration of mycophenolate mofetil in ambulatory children with JNCL. The secondary objective is to gather preliminary evidence of the short-term (8 week) impact of mycophenolate mofetil on cl...
What is the current status of trial NCT01399047?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2011-07. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01399047?
The interventions under investigation include: Mycophenolate mofetil (DRUG), Liquid Placebo (DRUG).
Who is sponsoring clinical trial NCT01399047?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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