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STOP NEUROMA
Surgical Treatment Of symPtomatic NEUROMA:
Open non-randomized clinical investigation to evaluate the safety and effectiveness of the nerve capping device to prevent neuroma formation after traumatic nerve section

Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…

Frozen gloves for prevention of chemotherapy-induced peripheral neuropathy

The primary objective is to evaluate the effectivity of frozen gloves during chemotherapy in the prevention of neurotoxicity and thereby the influence on the quality of life in patients treated with oxaliplatin, paclitaxel or docetaxel.

A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy

Primary objective:To assess the safety of repeat applications of QUTENZA administered over a period of 12 months in subjects with PDPN.Secondary objectives:To assess the efficacy of repeat applications of QUTENZA administered over a period of 12…

A Randomized controlled trial comparing two different immunoglobulins in the treatment of CIDP.

To investigate if:-Kiovig is at least as effective as Gammagard. (equivalence)-Kiovig has a good side effect profile for CIDP patients.-Whether patients prefer Kiovig to Gammagard.

Efficacy, safety and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutations related small fiber neuropathy: a randomized, double-blind, placebo controlled, crossover trial

Study Rationale and ObjectivesThe objective of the study is to determine the efficacy and safety of lacosamide, a sodium channel blocker, in patients with pain due to SCN9A-associated SFN. The proposed study plans to recruit patients with clinically…

Venlafaxine for prevention of oxaliplatin-induced peripheral neuropathy - A randomised clinical trial

Given the significant number of patients with OIPN and the possible prophylactic properties of venlafaxine, this study is designed. This study will consist of a randomised placebo-controlled clinical trial to study the prophylactic effect of…

A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Primary objective:To evaluate the efficacy of ION-682884, based on the change from Baseline in serum Transthyretin (TTR) concentration, modified Neuropathy Impairment Score +7 (mNIS+7), and Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (…

*Randomized controlled prospEctiVe trial comparing extended-release with immediate-release tacrOlimus; reducing calcineurin inhibitor related toxicity in LUng TransplantatION patients*

Primary Objective: to show a reduction in eGFR decline in patients treated with LCP tacrolimus compared to IR tacrolimus. Secondary objectives will include investigating the potential decline in other known side effects of calcineurin inhibitors i.e…

Old Title: International, multi-center, open label 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.;New title : International, multi-center, open label FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.

The primary objectives:Period 1:The primary objective is to assess the long-term (up to 2 years) safety and tolerability of two doses of PXT3003.Period 2:For patients continuing after V9, the main objective will be to offer patients the opportunity…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)

Primary:To determine the efficacy of AG10 in the treatment of subjects with symptomatic transthyretin amyloid polyneuropathy (ATTR-PN) by evaluating the difference between the AG10 and placebo groups in Modified Neuropathy Impairment Score + 7 (mNIS…

Intravenous immunoglobulin therapy for small fiber neuropathy: a randomized, double-blind, placebo-controlled study on efficacy and safety.

Primary objective: To evaluate the efficacy of IVIg treatment (4 courses of treatment, 3 weeks apart) compared to placebo on pain alleviation. Secondary objectives: 1. Pain intensity, pain qualities, and other SFN related complaints, daily and…

Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP (OPTIC trial)

Primary objective of this randomized controlled trial is to assess whether combining IVIg and IVMP leads to more frequent long-term remission in CIDP compared to treatment with IVIg alone. Main secondary objectives are to assess whether IVIg and…

Efficacy of a predefined vitamin D dosing regimen in vitamin D-insufficient multiple myeloma patients.

The primary objective of this study is to determine the efficacy of a predefined vitamin D dosing regimen on the prevalence of vitamin D insufficiency in MM patients. Secondary objectives are to detect the influence of several variables (age, gender…

International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months

Primary objective:To assess the efficacy of PXT3003 compared to Placebo on the disability measured by the ONLS score in CMT1A patients treated for 15 months.Secondary objectives:- To assess the efficacy of PXT3003 compared to Placebo on clinical and…