RESEARCH STUDY IN BOSTON
Massachusetts General Hospital is one of several sites that are conducting research trials for the Complex Regional Pain Syndrome treatment, Neridronate. We contacted study coordinator, Katie O’Neil and below is some information about this study which is open to people over the age of 18.
What are the acceptable ages (we have a majority of pediatric patients but some over 18 as well)?
The acceptable ages are 18 years old- 80 years old.
What criteria is needed (i.e. certain limb, full body, etc.)?
We base it on the Budapest Criteria so the subject should have symptoms from 3 of the 4 categories:
Sensory- these symptoms include pain to light touch or to pinprick
Vasomotor- these symptoms include temperature asymmetry (the affected area is colder or warmer than the other limb) as well as skin color changes in the affected area.
Sudomotor/oedema- these symptoms include swelling or any sweating changes (either the person could sweat more or less in the affected area).
Motor/tropic- these symptoms include decreased range of motion, or weakness, tremor or any changes in their hair/nails/skin. Again this is in the affected area.
Also, the subject must have a pain score above 4 and be diagnosed with CRPS-type 1.
Will there be a placebo group as well?
Yes there will be a placebo group. The study is double blinded so the subject isn’t going to know if they are getting the medicine or the placebo and neither do we as the researchers.
If a patient is interested, whom should they contact?
They should contact me. Again my name is Kate O’Neil and the best number to reach me at is 617-726-9391.
Will there be any reimbursement if people are travelling, or for other reasons?
There is a travel stipend. It is $1500 for the whole study. The study will last 12 months and there will be 11 visits during that time.
What is the treatment for this trial?
Neridronic Acid—I like to suggest that people Google it. There is an article written by Italian scientists who did this study in Europe. The medication is now approved for use in Europe and the sponsor of this trial is trying to get it approved by the FDA here in the US.