Summary:
Northern California Research is conducting a trial in evaluating the safety and effectiveness of neridronic acid for patients diagnosed with Complex Regional Pain Syndrome (CRPS). Its effectiveness in reducing pain due to CRPS and its effect on your ability to perform daily activities, quality of life and other outcomes will also be studied.
Currently, there is no approved treatment for pain associated with CRPS. This leaves many with the condition unable to find effective relief from the extreme pain it often causes. As a result, there is a need for treatment options that provide people with pain relief from CRPS.
The trial pain medication being evaluated in this trial has been studied in CRPS patients before and is approved in Italy for the treatment of CRPS. The results of this trial will provide doctors with more information about the trial medication and whether it could one day be used to treat CRPS pain in the U.S.. From a previous trial in the U.S., treatment with neridronoic acid suggests to result in clinically significant reductions in pain and other symptoms associated with CRPS. During the study you will be able to continue treatment with most of your medications for pain as well as physical therapy or other therapy you routinely receive.
Medications in this trial will be given through infusions, which is when a needle is inserted into a vein. These infusions will take place at the trial clinic where a doctor or staff member will oversee and administer the infusions.
All patients will receive four infusions of their assigned medication at the clinic over a 10-day period. Total participation in the trial will last up to 14 months and include up to 11 visits to the trial clinic.
The trial doctor will review other eligibility criteria with you. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.
Qualified Participants Must:
• Be 18 years of age or older
• Have a medical diagnosis of CRPS
• Have a pain score of 4 or greater on a daily basis
• Be in stable treatment for CRPS for at least 1 month
Qualified Participants May Receive:
Eligible patients will receive study medication through infusions, which is when a needle is inserted into a vein. These infusions will take place at the trial clinic where a doctor or staff member will oversee and administer the infusions. All patients will receive four infusions of their assigned medication at the clinic over a 10-day period. Total participation in the trial will last up to 14 months and include up to 11 visits to the trial clinic.
The trial doctor will review other eligibility criteria with you. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.