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

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 and capable of supervising treatment, providing input
into efficacy and safety assessments, and accompanying the patient to study visits.

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

- 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 inclusion/exclusion criteria may apply