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GZ402665 for Niemann-Pick Disease
Study Summary
This trial is testing the safety of a drug for a disease that causes problems with fat metabolism.
- Niemann-Pick Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 & 3 trial • 36 Patients • NCT02004691Trial Design
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Who is running the clinical trial?
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- You are taking certain medications like fluoxetine, chlorpromazine, or tricyclic antidepressants that could interfere with the effectiveness of olipudase alfa.
- Group 1: GZ402665
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other tests have been conducted with GZ402665 as the primary experimental agent?
"Presently, two trials analyzing the effects of GZ402665 are in progress with one evaluation at Phase 3. Although primarily conducted within New york City, 54 sites across the country are participating in these studies."
Is enrollment in this clinical trial currently available to participants?
"According to clinicaltrials.gov, applications for this trial are not open as of June 1st 2022; the original posting date was December 4th 2013. Nevertheless, 12 other medical experiments remain active and recruiting participants at present."
What is the designated status of GZ402665 by the Food and Drug Administration?
"Given its Phase 2 status, GZ402665 received a safety rating of 2 - indicating that prior clinical data exists to support the drug's security but there is no evidence demonstrating efficacy."
How many participants have been included in this trial?
"At this juncture, recruitment for this specific clinical trial has been suspended. The posting of the study was first noted on December 4th 2013 and last edited June 1st 2022. For those seeking participation in similar studies, 10 trials related to sphingomyelin lipidosis are actively recruiting while there are 2 separate investigations involving GZ402665 that can be joined."
Is this an unprecedented medical trial?
"Currently, 2 trials of GZ402665 are occurring in 9 cities and 17 nations. The first examination began in 2013 under the auspices of Genzyme, a Sanofi Company. They enrolled 25 patients to progress through Phase 2 drug approval stages. Since then, two more investigations have been conducted."
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