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Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients

NCT00718341 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-11

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

AF056

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis investigator site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-02-28

Countries

  • France
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718341 on ClinicalTrials.gov