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Neuralgia clinical trials

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NCT ID: NCT01486108 Completed - Neuropathic Pain Clinical Trials

Burst Spinal Cord Stimulation for Neuropathic Pain

Start date: January 2011
Phase: N/A
Study type: Interventional

Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.

NCT ID: NCT01485185 Completed - Pain, Neuropathic Clinical Trials

Gabapentin and Donepezil Combination on Experimental Human Pain Models

Start date: October 11, 2011
Phase: Phase 1
Study type: Interventional

This study will compare the effects of gabapentin alone, and gabapentin + donepezil given together in two types of experimental electrical pain tests in up to 48 healthy male subjects (after 24 recruited in the first cohort an interim analysis will be performed). The study is a randomized, double blind, placebo controlled, 3 was cross-over design study with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose and higher dose) or gabapentin (lower dose) with donepezil.

NCT ID: NCT01483846 Completed - Neuropathic Pain Clinical Trials

Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers

Start date: December 2011
Phase: Phase 1
Study type: Interventional

This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.

NCT ID: NCT01463397 Completed - Neuropathic Pain Clinical Trials

Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain

Alchemilla
Start date: March 2012
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS). Secondary Objectives: - To compare the effects of SAR292833 with placebo on the change of neuropathic pain symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI); - To evaluate the effects of SAR292833 in comparison to placebo on the change in pain intensity of mechanical allodynia; - To investigate the safety and tolerability of SAR292833 in comparison to placebo; - To investigate the pharmacokinetics (PK) and the relationships between main efficacy parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in patients with chronic peripheral neuropathic pain.

NCT ID: NCT01455428 Completed - Clinical trials for Postherpetic Neuralgia ( PHN )

Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

Start date: December 2011
Phase: Phase 4
Study type: Interventional

To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).

NCT ID: NCT01450163 Completed - Pain Clinical Trials

Evaluate The Efficacy and Safety Of Pregabalin In Prevention, Reduction of Oxaliplatin-Induced Painful Neuropathy

PreOx
Start date: August 2011
Phase: Phase 3
Study type: Interventional

Oxaliplatin (Ox) is part of most treatment regimens for colorectal cancer. However, it may induce side effects, such as a specific injury to peripheral nerves called neuropathy. Ox-induced neuropathy is frequently painful. The presence of pain after its administration may hamper the full chemotherapeutic treatment of patients with colorectal cancer receiving this agent. Recently, it has been suggested that the appearance of acute neuropathy after oxaliplatin (Ox) infusion could predict the distal polyneuropathy seen some months after treatment. These two adverse events related to Ox treatment probably share different mechanistic backgrounds. However, recent experimental data suggest that both types of peripheral neuropathies are able to induce central sensitization, a major step to the occurrence of chronic pain. Pregabalin is a molecule used to teat neuropathic pain since it can diminish the peripheral sensitization seen in this painful condition. Recently, it has also been shown that pregabalin can be used to treat neuropathic pain related to Ox treatment. In the present study, we will test the hypothesis that Pregabalin administrated exclusively for three days before and three days after the Ox infusion is able to prevent the occurrence of pain secondary to both the acute and chronic Ox-associated neuropathies. In the classical FLOX chemotherapeutic regimen, Ox is infused in nine sessions during a six-month period. Patients will be followed for a year and nerve conduction tests, quantitative sensory evaluation, pain, quality of life and functional scales will be used to assess the impact of this strategy in the prevention of pain. If this strategy proves to work, this information will have a major impact in the cancer prognosis of patients with colorectal cancer since Ox will be able to administer in its full dose, and will not be limited by neuropathic side effects.

NCT ID: NCT01447108 Completed - Clinical trials for Trigeminal Neuralgia

Surface Acoustic Wave Ultrasound in Trigeminal Neuralgia Pain

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The "Suicide Disease", Trigeminal Neuralgia (TN) is arguably caused by one of the most discrete and eloquently reversible central nervous system lesions known to the field of neurology. Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects with refractory TN showing a remarkable positive response rate to TN's treatment with Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU). The primary objective of this study, therefore, is to determine whether this apparent efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could withstand the rigors of an n=1 crossover placebo control study. Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for at least six months will be screened for participation in the study based on rigorous inclusion and exclusion criteria. It is judged rather unlikely that such subjects will experience spontaneous regression of their disease in the course of this study. Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU therapy for the next four weeks. Patients will be blinded to all treatments throughout the study. Patients will be instructed to use the device daily overnight, and remove it upon wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off, for a total of six- eight hours of intermittent treatment. At the end of the second month of the study, patients will be offered a choice as to whether they wished to continue with the current (active) device or go back to the 1st (sham) device. Patient's pain severity will be tracked every two weeks over the course of three months. Functional health and well being will be monitored at intake, post "Placebo" period, post "Active" period and at completion of the study.

NCT ID: NCT01435798 Completed - Spinal Cord Injury Clinical Trials

Clinical Neuropharmacology of Pain in Spinal Cord Injury

Start date: August 2000
Phase: Phase 2
Study type: Interventional

This study is an NIH-funded two-part clinical trial to determine the best dose-ratio of individual subjects with central neuropathic pain following spinal cord injury (SCI), when two compounds with different target mechanisms are administered as combination therapy. The investigators will first determine each subjects' maximally tolerated dose (MTD) of chronic oral (PO) administration of dextromethorphan (Dex); the investigators will then randomize subjects to receive multiple dose-combinations of dextromethorphan and lidocaine (Lido). The investigators will be able to determine each subject's individual dose-response relationship for the separate compounds with adequate power, and thus also confirm the analgesic efficacy of high dose dextromethorphan and lidocaine, each in central neuropathic pain.

NCT ID: NCT01429181 Completed - Clinical trials for Diabetic Peripheral Neuropathic Pain

Efficacy & Safety Study of Nonracemic Methadone for the Relief of Chronic Peripheral Neuropathic Pain

Start date: January 2012
Phase: Phase 2
Study type: Interventional

There is a growing evidence that the d-isomer of methadone is effective in treating neuropathic pain while the l-isomer of methadone is the only effective isomer of methadone for treating somatic pain. This study will examine a combination of different amounts of the d- and l-isomers of methadone specifically tailored to the chronic peripheral neuropathic pain. Non-racemic mixture of methadone isomers will be tested in this pilot efficacy and safety study. This study will evaluate effect of the three doses of the non-racemic mixture of methadone hydrochloride patients with chronic peripheral neuropathic pain compared with a placebo. The study will also examine the minimally effective and maximally tolerated doses of the non-racemic mixture of methadone. Finally, the safety and tolerability of the non-racemic methadone therapy will be evaluated.

NCT ID: NCT01426230 Completed - Clinical trials for Post Herpetic Neuralgia

Phase IV Study of FDA Approved, Once-Daily GRALISEā„¢(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia

Start date: September 2011
Phase: N/A
Study type: Observational

Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice