Polyneuropathy Clinical Trial
Official title:
NARC 011: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Methadone and Combination of Methadone and SAB378 in HIV-associated Painful Peripheral Neuropathy
The purpose of this study is to evaluate the effectiveness of methadone alone and in combination with SAB378 for the treatment of painful HIV-associated neuropathy.
Distal sensory polyneuropathy is the most common neurological complication of HIV disease and
its treatment. To date no standard effective therapy has been identified.
In this study, scientists will evaluate the effectiveness of treating HIV-associated
neuropathy with methadone alone and in combination with a novel cannabinoid SAB378. A
cannabinoid is a molecule found only in the Cannabis plant. Cannabis and some cannabinoids
are effective analgesics or pain relievers. The rationale for combination therapy is twofold:
(1) medications with unique mechanisms of action may affect different aspects of neuropathic
pain and (2) combination therapy may act synergistically—meaning the combined effect may be
greater than the effect of each drug alone.
Approximately 84 participants will be enrolled in this double-blind, placebo-controlled,
crossover study. Participants will be randomly assigned to three treatment groups—those
receiving methadone and SAB378 placebo (an inactive substance), those receiving methadone and
active SAB378, or those receiving methadone placebo and SAB378 placebo. All participants will
be exposed to each of the 3 treatment groups during the study.
This trial is part of the Neurologic AIDS Research Consortium, an effective collaborative
clinical study group dedicated to the study of HIV-associated neurological disease.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05560555 -
Retrospective Study Collecting Neurological Follow-up of Hereditary Transthyretin Amyloidosis (ATTRv) Patients Included in B3461028 and B3461045.
|
||
| Recruiting |
NCT02033057 -
Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
|
Phase 4 | |
| Withdrawn |
NCT02566941 -
Neuromuscular Electrical Stimulation in the Critically Ill
|
N/A | |
| Completed |
NCT02442986 -
Neurological Outcome in Surgical and Non-surgical Septic Patients
|
N/A | |
| Completed |
NCT02706314 -
Impact of Human Blood Serum From Critically Ill Patients on Human Colon Neuronal Networks.
|
||
| Completed |
NCT01076478 -
Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines
|
Phase 4 | |
| Completed |
NCT03373370 -
Early Diagnosis of TTR Amyloidosis by Use of Molecular Biology
|
||
| Completed |
NCT02846844 -
Patients With Chemotherapy-induced Polyneuropathy Are Treated With an Integrated Program Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training
|
N/A | |
| Recruiting |
NCT05950867 -
Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause.
|
N/A | |
| Terminated |
NCT00832572 -
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
|
Phase 4 | |
| Completed |
NCT00614562 -
Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Critical Illness Associated Polyneuropathy / or Polymyopathy (CIP/M)
|
Phase 1 | |
| Terminated |
NCT01088256 -
Efficacy of Etoricoxib on Peripheral Hyperalgesia
|
Phase 2 | |
| Completed |
NCT01302275 -
Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain
|
Phase 4 | |
| Not yet recruiting |
NCT01047488 -
Imipramine and Pregabalin Combination in Painful Polyneuropathy
|
Phase 4 | |
| Recruiting |
NCT06414746 -
Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia
|
||
| Completed |
NCT04201418 -
A Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients With Polyneuropathy of ATTRv Amyloidosis With a V122I or T60A Mutation
|
||
| Completed |
NCT01450163 -
Evaluate The Efficacy and Safety Of Pregabalin In Prevention, Reduction of Oxaliplatin-Induced Painful Neuropathy
|
Phase 3 | |
| Recruiting |
NCT05040373 -
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
|
||
| Not yet recruiting |
NCT02666456 -
The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
|
N/A | |
| Completed |
NCT00259974 -
RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
|
Phase 3 |