An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome
- Conditions
- Fragile X Syndrome1008362410057167
- Registration Number
- NL-OMON38786
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Group 1 patients:
* Must have completed the CAFQ056B2214 or another study of AFQ056 which included
FXS patients below 18 years of age within one week of enrollment into the open-label study;Group 2 patients:
* Must meet one of the following conditions:
o completed Study CAFQ056B2214 or another study of AFQ056 which included FXS patients below 18 years of age but enrollment into the current study was delayed for more than a week
o discontinued prematurely from Study CAFQ056B2214 or another study of AFQ056 which included FXS patients below 18 years of age due to intolerability of the dosage in the patient*s assigned treatment group
* Discontinuation from CAFQ056B2214 or another study of AFQ056 which included FXS patients below 18 years of age due to safety reasons
* History of severe self-injurious behavior
* History of clinically significant allergies requiring hospitalization or non-inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether or not there is evidence of local recurrence or metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Incidence and severity of adverse events and serious adverse events<br /><br>* Changes in vital signs, laboratory assessments, and ECGs<br /><br>* Monitoring the hypothalamic-pituitary-adrenal/thyroid axis function and<br /><br>childhood developmental milestones</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Change from baseline in the Aberrant Behavior Checklist * Community edition<br /><br>(ABC-C) total score and subscale scores (using the FXS specific algorithm *<br /><br>ABC-CFX)</p><br>