Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

ClinicalTrials.gov ID: NCT01253629

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Official title

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate AFQ056 in Adult Patients With Fragile X Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.

Study identification

NCT ID: NCT01253629
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 175 participants

Conditions and interventions

Conditions

Fragile X Syndrome

Interventions

AFQ056 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2010 (Type not available)
Primary completion: Aug 2013 (Actual)
Completion: Aug 2013 (Actual)
Last update posted: Dec 23, 2020

2010 – 2013

United States locations

U.S. sites: 12
U.S. states: 12
U.S. cities: 12

Facility	City	State	ZIP	Site status
Novartis Investigative Site	Phoenix	Arizona	85006	—
Novartis Investigative Site	Sacramento	California	95817	—
Novartis Investigative Site	Decatur	Georgia	30033	—
Novartis Investigative Site	Chicago	Illinois	60612	—
Novartis Investigative Site	Indianapolis	Indiana	46202	—
Novartis Investigative Site	Boston	Massachusetts	02115	—
Novartis Investigative Site	Omaha	Nebraska	68198-5575	—
Novartis Investigative Site	Staten Island	New York	10314	—
Novartis Investigative Site	Media	Pennsylvania	19063	—
Novartis Investigative Site	Greenwood	South Carolina	29646	—
Novartis Investigative Site	Nashville	Tennessee	37212	—
Novartis Investigative Site	Houston	Texas	77090	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01253629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 23, 2020 · Synced Nov 12, 2026