Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluvoxamine · 1 trial · 1 indication
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum of three tablets twice a day. From weeks 7 to 10 participants received the same dose that was given during week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week. |
| Fluvoxamine | EXPERIMENTAL | In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given during week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week. |
| Name | Type | Description |
|---|---|---|
| Fluvoxamine maleate | DRUG | Film-coated tablet containing 25 mg of fluvoxamine maleate |
| Placebo | DRUG | Placebo tablet matching to fluvoxamine maleate |
Inclusion Criteria: 1. Subject has at least 16 points on Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score and at least 5 points in Obsession sub-total score and in Compulsion sub-total score respectively at the Screening period and Baseline. 2. Subject sh...
Fluvoxamine is used for Obsessive Compulsive Disorder (OCD). It is being studied in pediatric and adolescent patients with this condition. The drug is a small molecule being developed by AbbVie Inc. for the treatment of OCD.
Fluvoxamine is a small molecule being developed for Obsessive Compulsive Disorder. Its specific molecular target is not disclosed in the available information, so its mechanism of action is not detailed here.
Fluvoxamine is being developed by AbbVie Inc., a biopharmaceutical company listed on the stock exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug for Obsessive Compulsive Disorder.
Fluvoxamine is in Phase 3 clinical development. It is an investigational drug being studied for Obsessive Compulsive Disorder in pediatric and adolescent patients. The Phase 3 trial has been completed, but the drug is not yet approved.
Fluvoxamine has one completed Phase 3 clinical trial with the identifier NCT01933919. The trial, titled 'A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder', enrolled 38 participants aged 6 years and older.
Yes, Fluvoxamine is also known as SME3110. The Phase 3 clinical trial NCT01933919 refers to Fluvoxamine as SME3110, confirming that these names refer to the same drug being developed for Obsessive Compulsive Disorder.