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NCT01482143 · ClinicalTrials.gov registry record · Phase 1

Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)

A Phase 1 study of Fragile X Syndrome, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
4
Study locations

NCT01482143 is a Phase 1 study of Fragile X Syndrome that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 21 participants, below the 100-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT01482143, a Phase 1 study of Fragile X Syndrome, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
4
Study locations

Study Summary

The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)

Conditions Studied

Fragile X Syndrome

Interventions

  • DRUG AFQ056

Study Locations (4)

California

  • Novartis Investigative Site - Sacramento

Illinois

  • Novartis Investigative Site - Chicago

Tennessee

  • Novartis Investigative Site - Nashville

Catalonia

  • Novartis Investigative Site - Sant Cugat del Vallès

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2012-03
Est. Completion 2013-10
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT01482143

The ClinicalTrials.gov registry entry for NCT01482143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (79% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 1 intervention - of which AFQ056 is the first listed.

NCT01482143 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Illinois, Tennessee.

Frequently Asked Questions

What is clinical trial NCT01482143 about?

NCT01482143 is a clinical study titled "Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)". The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)

What is the current status of trial NCT01482143?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-03. Estimated completion is 2013-10.

What conditions does trial NCT01482143 study?

This clinical trial studies the following conditions: Fragile X Syndrome.

What interventions are being tested in trial NCT01482143?

The interventions under investigation include: AFQ056 (DRUG).

Who is sponsoring clinical trial NCT01482143?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01482143 being conducted?

This trial has 4 study locations across California, Illinois, Tennessee, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.