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This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO4917523 0.5 mg | Experimental |
| |
| RO4917523 1.5 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo to RO4917523 orally once a day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Depression and Mood Scale (ADAMS) total score | 12 weeks | |
| Safety (incidence of adverse events) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Responsiveness Scale (SRS) | 12 weeks | |
| Change in Clinical Global Impressions Scale - Improvement (CGI-I) | 12 weeks | |
| Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85006 | United States | |||
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| RO4917523 0.5 mg |
| Drug |
0.5 mg orally once a day for 12 weeks |
|
| RO4917523 1.5 mg | Drug | 1.5 mg orally once a day for 12 weeks |
|
| 12 weeks |
| Change in Aberrant Behavior Checklist total score | 12 weeks |
| Change in Aberrant Behavior Checklist factor scores | 12 weeks |
| Change in Anxiety Depression and Mood Scale (ADAMS) factor scores | 12 weeks |
| Long Beach |
| California |
| 90806 |
| United States |
| Sacramento | California | 95817 | United States |
| Aurora | Colorado | 80045 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Decatur | Georgia | 30033 | United States |
| Chicago | Illinois | 60612 | United States |
| Iowa City | Iowa | 52242-1083 | United States |
| Louisville | Kentucky | 40202 | United States |
| Baltimore | Maryland | 21205 | United States |
| Worcester | Massachusetts | 01655 | United States |
| New York | New York | 10029 | United States |
| Staten Island | New York | 10314 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45229 | United States |
| Media | Pennsylvania | 19063 | United States |
| Nashville | Tennessee | 37203 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78258 | United States |
| Seattle | Washington | 98145 | United States |
| Bahía Blanca | 8000 | Argentina |
| Caba | 1425 | Argentina |
| Caba | C1126AAB | Argentina |
| Brampton | Ontario | L6Y 1M5 | Canada |
| Sherbrooke | Quebec | J1H 5N4 | Canada |
| Santiago | Chile |
| Valparaíso | 2340000 | Chile |
| Bordeaux | 33076 | France |
| Bron | 69003 | France |
| Dijon | 21079 | France |
| Marseille | 13385 | France |
| Montpellier | 34295 | France |
| Paris | 75013 | France |
| Tours | 37044 | France |
| Aguascalientes | 20030 | Mexico |
| México | 04530 | Mexico |
| Lima | Lima 33 | Peru |
| Lima | Peru |
| San Cugat Del Valles | Barcelona | 08195 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20009 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Torremolinos | Malaga | 29620 | Spain |
| El Palmar. Murcia | Murcia | 30120 | Spain |
| Gothenburg | 411 19 | Sweden |
| Belfast | BT12 6AB | United Kingdom |
| Dundee | DD1 9SY | United Kingdom |
| Edinburgh | EH10 5HF | United Kingdom |
| Glasgow | GS 8SJ | United Kingdom |
| London | W1W 7EJ | United Kingdom |
| Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
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| ID | Term |
|---|---|
| C000596770 | 2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine |
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