ong-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome

• Conditions: Fragile X Syndrome; MedDRA version: 14.1Level: PTClassification code 10017324Term: Fragile X syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001952-12-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-14
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Must have been enrolled in Studies CAFQ056A2204 or CAFQ056A2212

- Has a caregiver or caregivers who spend(s), on average, at least 6 hours per day with the patient , who is/are willing to and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits.

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Any advanced, severe or unstable disease

- Past medical history of clinically significant ECG abnormalities or QTcF>450 msec for males and > 470 msec for females at screening (Group 2) or at the CAF056A2212 end of study visit

- History of severe self-injurious behavior

- History of uncontrolled seizure disorder or resistant to therapy within the past 2 years (Patients who are clinically stable under anti-convulsant therapy for the past 2 years are not excluded)

- History of clinically significant allergies requiring hospitalization or non-inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)

- Any treatment regimen, including psychotropic and/or anticonvulsant therapy that has not been stable for = 6 weeks prior to randomization

- Using (or used within 6 weeks before randomization) concomitant medications that are potent inhibitors or inducers of CYP3A4

- Using glutamatergic agents (riluzole, memantine, etc.) or lithium within 6 weeks of randomization

- Planning to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified