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NCT01433354 · ClinicalTrials.gov registry record · Phase 2

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
119
Enrollment target

NCT01433354 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 119 participants.

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The verdict

NCT01433354, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
119 participants
Enrollment target

Study Summary

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

Interventions

  • DRUG AFQ056

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2011-11
Est. Completion 2014-09
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01433354

The ClinicalTrials.gov registry entry for NCT01433354 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AFQ056 is the first listed.

NCT01433354 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01433354 about?

NCT01433354 is a clinical study titled "Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)". The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provi...

What is the current status of trial NCT01433354?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2011-11. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01433354?

The interventions under investigation include: AFQ056 (DRUG).

Who is sponsoring clinical trial NCT01433354?

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

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

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.