Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minalcipran 100 mg | Experimental |
| |
| Minalcipran 150 mg | Experimental |
| |
| Minalcipran 200 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milnacipran | Drug | hard capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaime C BRANCO, MD | HOSPITAL EGAS MONIZ, Lisboa, Portugal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Ambulance | Pardubice | 530 02 | Czechia | |||
| Kuopion Oma Laakari Oy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21459941 | Derived | Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | hard capsule |
|
| Kuopio |
| 70100 |
| Finland |
| Hopital Hotel Dieu | Paris | France |
| KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care | Cologne | D50931 | Germany |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Center For Clinical Studies | Lillehamer | 2609 | Norway |
| Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Dr I CANTACUZINO CLINICAL HOSPITAL | Bucharest | 020475 | Romania |
| Hospital de La Esperanza | Barcelona | 08024 | Spain |
| Gottfriesclinic Ab | Mölndal | 43137 | Sweden |
| D009422 |
| Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |