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



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 46
Updated:2/7/2015
Start Date:August 2011
End Date:August 2014
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

The purpose of this study is to generate long-term safety, tolerability and efficacy data
for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212
core study and patients who have participated in the previous proof-of-concept study
CAFQ056A2204.


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
We found this trial at
13
sites
Decatur, Georgia 30030
2182
mi
from 98109
Decatur, GA
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Boston, Massachusetts 02118
2485
mi
from 98109
Boston, MA
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Chicago, Illinois 60612
1730
mi
from 98109
Chicago, IL
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Greenwood, South Carolina 29646
2262
mi
from 98109
Greenwood, SC
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
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Media, Pennsylvania 19063
2364
mi
from 98109
Media, PA
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Nashville, Tennessee 37205
1969
mi
from 98109
Nashville, TN
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Omaha, Nebraska 68144
1359
mi
from 98109
Omaha, NE
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Phoenix, Arizona 85012
1112
mi
from 98109
Phoenix, AZ
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Sacramento, California 95825
626
mi
from 98109
Sacramento, CA
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Seattle, Washington 98103
1
mi
from 98109
Seattle, WA
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Staten Island, New York 10312
2398
mi
from 98109
Staten Island, NY
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