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-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Must have been enrolled in Studies CAFQ056A2204 or CAFQ056A2212 - Has a caregiver who spends, on average, at least 6 hours per day with the patient , who is 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

Exclusion Criteria

- Any advanced, severe or unstable disease - 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 - Current treatment with more than two psychoactive medications, excluding medication used specifically for seizure control - 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