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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…

Efficacy, safety and tolerability of multiple doses of oral cebranopadol in subjects with moderate to severe chronic pain due to diabetic peripheral neuropathy

To assess the analgesic efficacy, safety, and tolerability of once daily orally administered cebranopadol in a total of 3 fixed doses (100 µg, 300 µg, and 600 µg cebranopadol) compared to placebo in subjects with moderate to severe chronic pain due…

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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-Traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-Label Safety Extension

Primary Objectives• To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia neuralgia • To…

Phase 2a, Double-Blind, Placebo-Controlled, 2-Period, 2-Treatment, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 (400 mg bid) in Patients with Inherited Erythromelalgia

• To evaluate the safety and efficacy of multiple doses of XPF-001 (400 mg bid) for relief of pain in patients with IEM.• To evaluate the efficacy of multiple doses of XPF-001 (400 mg bid) for relief of vasomotor signs in patient with IEM.• To…

Effects of ARA 290 on the regrowth of epidermal nerve fibers in normal volunteers and patients with sarcoidosis

In this study we will assess the effect of ARA290 on nerve damage by taking 4 skin bipsies during treatment.

A double blind, placebo controlled Phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of subjects with sarcoidosis

ARA290 is a new drug against neuropathic pain and was succesfully tested in previous studies on patients with neuropathic pain due to diabetes and sarcoidosis. The current study involves sarcoidosis patients with pain due to neuropathy. The purpose…

Treatment of Complex Regional Pain Syndrome type 1: A randomized placebo controlled double-blind study with ARA 290, The CRPSARA Study

Study AimsPrimary Aim: This is a proof-of-concept study to evaluate the effect of ARA 290 in pain of patients with CRPS1 by means of once daily subcutaneous injection with ARA 290 for 4 weeks. Secondary Aims: * Assess the predictive effect of…

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of Carisbamate in the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy Followed by a Blinded Extension Phase

OBJECTIVESPrimary ObjectiveThe primary objective is to evaluate the efficacy, safety, and tolerability of 800 and 1,200 mg/day of carisbamate compared with placebo in reducing the average daily pain in subjects with diabetic peripheral neuropathy (…

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…

Multicenter, open*label, phase II study in patients with monoclonal
gammopathy of unknown significance (MGUS) and anti Myelin Associated
Gycoproteine (MAG) Neuropathy and Zanubrutinib Treatment * MAGNAZ trial

Main objective:To improve the functional neurological outcome of patients, as measured on the Raschbuilt Overall Disability Scale (RODS) for inflammatory neuropathies (iRODS) with Zanubrutinib in combination with standard treatment with Rituximab or…

Randomized controlled trial of controlled hand/foot cooling to prevent neuropathy and preserve quality of life in adults treated with oxaliplatin.

This randomized phase II open label study examines the effect of controlled cooling versus no cooling on the incidence and severity of oxaliplatin-induced peripheral neuropathy (OIPN) in patients treated with oxaliplatin.

Enrichment randomized double-blind, placebo-controlled cross-over trial with PHEnytoin cream in patients with painful chronic idiopathic axonal polyNEuropathy

The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to CIAP. The second objective is to determine the predictive value of a DOBRET to identify sustained responders.

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…

Neuromodulation of the Dorsal Genital Nerve in Patiënts with Persistent Genital Arousal Disorder

The primary aim is to investigate the effect of neuromodulation (via UCon) on the symptoms of patients with PGAD. The hypothesis we want to test is whether neuromodulation of the DGN reduces the severity of symptoms of PGAD.