WHO ICTRP trial
An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety…
NL-OMON42982 · Overview of Medical Research in the Netherlands (NL-OMON)
Key facts
| Trial ID | NL-OMON42982 |
|---|---|
| Public title | An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects WithNeuropathic Pain From Lumbosacral Radiculopathy |
| Scientific title | An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects WithNeuropathic Pain From Lumbosacral Radiculopathy - Open-Label study to evaluate long-term effects of BIIB074 from PLSR |
| Primary sponsor | Convergence Pharmaceuticals Ltd., a Biogen company |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Study type | Interventional |
| Phase | 2 |
| Countries | Austria;Belgium;Bulgaria;Czechia;France;Georgia;Italy;Latvia;Netherlands ;Romania;Serbia;Slovakia;Spain;United Kingdom;United States of America |
| Conditions | Hernia Pain From Lumbosacral Radiculopathy (PLSR);10041543;Hernia;Pain From Lumbosacral Radiculopathy (PLSR) |
| Interventions | Subjects will receive an initial dose regimen of 350 mg twice daily (BID) of BIIB074, which may be reduced to 200 mg BID based on tolerability. ;Leg pain NRS;Lumbosacral radiculopathy;Neuropathic pain;Sodium channel blocker |
| Registration date | Apr 10, 2017 |
| Target size | 28 |
| Secondary IDs | 2015-004796-68;NL59147.091.16 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: