Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00933686 | Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome | PHASE3 | COMPLETED | 113 | — | — | Dec 1, 2007 | Jul 1, 2010 | Aug 2, 2013 | 1 | Spain |
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
| Arm | Type | Description |
|---|---|---|
| Saizen® | ACTIVE_COMPARATOR | - |
| Placebo + Saizen® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Saizen® | DRUG | Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) will be administered subcutaneously daily for 12 months. Dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 1, 3, 7 and 9. |
| Placebo and Saizen® | DRUG | Placebo matched to Saizen® will be administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 7 and 9. |
Inclusion Criteria: * Women aged greater than or equal (\>=) 18 years * Fibromyalgia diagnosed at least one year before * History of generalized pain and at least 16 positive tender points (1990 American College of Rheumatology \[ACR\] criteria) * Body Mass Index (BMI) less than or equal to(=\<) 32...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | — | Undisclosed |