Ralfinamide clinical trial

A multicentre, double-blind, randomised, placebo-controlled, week study with long-term extension. Neuropathic pain is caused by damage or dysfunction in one or more of the nerves. It is estimated that about 1 in people in the UK have persistent chronic neuropathic pain. In most cases there is no specific injury or damage to tissues that cause the pain. Nociceptive pain resulting from tissue damage can be treated with anti-inflammatory drugs and other pain relief medication. However, neuropathic pain does not respond well to this treatment and the condition remains largely untreated.

The sponsor of this clinical trial, Newron Pharmaceuticals S. This trial aims to assess the safety, tolerability and analgesic pain killing efficacy of ralfinamide. More Information. A ClinicalTrials. National Library of Medicine U.

National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Neuropathic Pain. Drug: Ralfinamide.

Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Detailed Description:. Arms and Interventions. Outcome Measures.

Primary Outcome Measures : The primary efficacy variable will be the change from baseline in the mean weekly pain score point Likert scale. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Patient must have chronic neuropathic low back pain with a minimum intensity of "40 mm" moderate or greater on the Visual Analogue Scale VAS; mm at screening, and an average of "40 mm" or more at baseline based on prior 7 days.

The onset of pain has occurred at least three months, but not longer than 3 years, prior to the screening visit, as assessed by the investigator in the patient's medical history.

Patient's low back pain has a clear neuropathic component, as indicated by a rating on the Pain Detect Questionnaire PD-Q of greater than Patient is years of age, inclusive. Patient is willing and able to understand and sign an approved Informed Consent Form. Exclusion Criteria: 1. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: Ralfinamide. Phase 3.