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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01482143 record still lists

NCT01482143 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 100-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (79% lower).

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 a single indexed study location in 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.

Similar trials for Fragile X Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01482143's enrollment target sits among peer trials

21 14th of 16 higher than 3 of 16 other Fragile X Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fragile X Syndrome 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01482143, the US trial registry maintained by the National Library of Medicine. NCT01482143 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.