Ongoing Clinical Trials for Peripheral Sensorimotor Neuropathy
There is currently 1 ongoing clinical trial investigating new treatment options for peripheral sensorimotor neuropathy, specifically in patients with Primary Sjögren’s Syndrome. This trial is being conducted in France and focuses on testing the effectiveness of intravenous immunoglobulin therapy in reducing nerve-related pain and improving quality of life.
Clinical trial locations
Study on the Effectiveness of Human Normal Immunoglobulin for Treating Painful Nerve Damage in Patients with Primary Sjögren’s Syndrome
This clinical trial is investigating whether a treatment called Privigen can help people with Primary Sjögren’s Syndrome who are experiencing painful nerve damage. The condition being studied is peripheral neuropathy, which affects the nerves that send signals between the brain, spinal cord, and the rest of the body. This nerve damage can cause tingling, numbness, and pain, typically in the hands and feet, and may also lead to muscle weakness.
Main inclusion criteria:
- Age between 18 and 79 years old
- Confirmed diagnosis of Primary Sjögren’s Syndrome according to European and American criteria
- Presence of peripheral neuropathy that is either purely sensory (affecting feeling) or sensorimotor (affecting both feeling and movement), confirmed by electromyography testing
- Adequate kidney function with a clearance rate greater than 50 ml/min/1.73m²
- Completed viral screening for HIV and hepatitis
- Use of effective contraception during the study period
- Healthcare insurance coverage
- Ability to understand study information and provide written consent
Main exclusion criteria:
The trial excludes patients with clearly defined peripheral neuropathy that includes pure sensory neuropathy or sensorimotor neuropathies confirmed by electromyography testing, as well as those with Primary Sjögren’s Syndrome defined by European and American criteria. This appears to focus on selecting specific patient populations for the study.
Trial focus and goals:
The main goal of this study is to determine whether intravenous immunoglobulin treatment can effectively reduce nerve-related symptoms in people with Primary Sjögren’s Syndrome. Researchers aim to achieve at least a 20% improvement compared to placebo on specific measurement scales, including the R-ODS scale and the Numerical Pain Scale, three weeks after the last treatment course. The study will also evaluate improvements in quality of life, depression scores, fatigue levels, and other aspects related to both the autoimmune condition and the neuropathy.
Investigational drug:
The treatment being tested is Privigen, which contains polyvalent intravenous immunoglobulins. These are proteins normally found in blood that help the immune system function properly. The medication is given directly into the bloodstream through a vein over several weeks. It works by providing a broad range of antibodies that can help regulate the immune system’s activity and reduce inflammation, potentially relieving nerve pain and improving nerve function. Participants will be closely monitored throughout the treatment period to assess any improvements in their symptoms and to watch for any side effects. The study is expected to conclude by December 18, 2025.
Summary
Currently, there is one active clinical trial addressing peripheral sensorimotor neuropathy specifically in the context of Primary Sjögren’s Syndrome. The trial is being conducted in France and focuses on evaluating the potential benefits of intravenous immunoglobulin therapy using Privigen. This research represents an important step in exploring treatment options for patients who experience painful nerve damage as a complication of their autoimmune condition. The study takes a comprehensive approach by measuring not only pain reduction but also broader quality of life improvements, which are crucial factors for patients living with chronic nerve-related symptoms.