Clinical Trials Logo
  1. Home
  2. Neuropathic Pain
  3. NCT04480164

Evaluation of the Safety and Efficacy of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain — NDMC-201  

Neuropathic Pain Clinical Trial

Official title:
A Randomized Double-blind Ascending-dose Placebo-controlled Study of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain

Clinical Trial Summary

Neuropathic pain (NP) affects up to 8% of the general population and its successful management is an unmet medical need. Half of the patients report inadequate response to therapy and unwanted side effects such as sedation and cognitive impairments, limiting drug use in daily practice and significantly accounting for the high incidence of treatment failure. Dysfunction of synaptic inhibition within the spinal cord is known to be one of the main contributing factors to central sensitization that governs NP. Facilitation of GABAergic inhibition in the dorsal horn through GABAA receptors allosteric modulation would be a rational approach to NP management. New insights on the associations between GABAA receptors α subunits and function have opened new perspectives in preclinical research. Data from genetically modified mice demonstrates the possibility, through selective allosteric modulation of the GABAA receptor, to induce its beneficial antihyperalgesic effects without inducing its cognitive and sedative effects. N-Desmethylclobazam (NDMC), clobazam's main active metabolite, demonstrated in vitro and in vivo a high selectivity profile with a clear preference for GABAA α2-subtypes receptors (antihyperalgesia) over α1 receptors responsible for sedative effects across a wide concentration range. Taking into consideration the high prevalence and burden of neuropathic and chronic pain worldwide and the fact that these patients are nowadays left with sedative and only partially effective drugs, NDMC qualifies as a good molecule to seek confirmation of the clinical utility of selective GABAA allosteric modulators in NP patients.The main objective is to assess the efficacy of repeated doses of NDMC on neuropathic pain compared to placebo.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04480164
Study type Interventional
Source University Hospital, Geneva
Contact
Status Suspended
Phase Phase 2
Start date June 24, 2020
Completion date May 31, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04699734 - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Completed NCT05235191 - Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies Phase 3
Completed NCT05845177 - Persistent Pain After Hip Replacement
Not yet recruiting NCT05949554 - Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.
Withdrawn NCT05052645 - Ear Acupuncture for Neuropathic Pain N/A
Completed NCT02930551 - Neuromas as the Cause of Pain N/A
Completed NCT02824588 - Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain N/A
Completed NCT02866396 - Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
Active, not recruiting NCT02560545 - Cannabinoids Effects on the Pain Modulation System N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Not yet recruiting NCT02246517 - The Effect of N2O on Chronic Neuropathic Pain Patients Phase 0
Completed NCT02099890 - The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury Phase 3
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Completed NCT01718821 - Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients N/A
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01669967 - The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin N/A
Completed NCT01201317 - A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy Phase 2
Completed NCT01207596 - Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain Phase 4
Active, not recruiting NCT00996983 - Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer Phase 2