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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00718341 |
This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.
Condition | Intervention | Phase |
---|---|---|
Fragile X Syndrome |
Drug: AF056 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre, Randomized, Double-Blind, Placebo Controlled, Two-Period, Crossover Proof-of-Concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056 |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator | Drug: AF056 |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
France | |
Novartis Investigator Site | |
Bron cedex, France, 69677 | |
Italy | |
Novartis Investigator Site | |
Rome, Italy, 00168 | |
Switzerland | |
Novartis Investigator Site | |
Lausanne, Switzerland, 1011 |
Principal Investigator: | Novartis | Novartis investigator site |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CAFQ056A2204 |
Study First Received: | July 17, 2008 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00718341 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Fragile X Syndrome, adults, efficacy |
Mental Retardation Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn X-linked Mental Retardation and Macro-orchidism Genetic Diseases, X-Linked |
Chromosome Disorders Neurologic Manifestations Fragile X Syndrome Congenital Abnormalities Neurobehavioral Manifestations |
Disease Nervous System Diseases Chromosome Disorders Fragile X Syndrome Mental Retardation Pathologic Processes Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn |
Syndrome Genetic Diseases, X-Linked Neurologic Manifestations Sex Chromosome Disorders Mental Retardation, X-Linked Congenital Abnormalities Neurobehavioral Manifestations |