MYPS I
Research type
Research Study
Full title
Mycophenolate Treatment for Longstanding Complex Regional Pain Syndrome (MYPS I)
IRAS ID
172762
Contact name
Andreas Goebel
Contact email
Sponsor organisation
Walton Centre NHS Foundation Trust
Eudract number
2015-000263-14
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Complex Regional Pain Syndrome (CRPS) is often a distressing condition, which in many cases is difficult to treat. In this study we will use Mycophenolate, a drug which has been used for over 15 years to effectively treat other health conditions, but has only recently been researched as a treatment for pain. We think that Mycophenolate may be effective in CRPS because Mycophenolate treats the immune system and we know that the immune system is involved in CRPS.
The MYPS I study aims to gain an initial understanding, whether Mycophenolate, as an addition to standard treatment, can relieve the chronic pain from CRPS, and how well it is tolerated.
Participants must be =18 years old and been diagnosed with CRPS I or II for over 2 years, without other significant chronic pains. Participants must have a mean pain intensity of 5 or above on an 11 point numerical rating scale (0='no pain', 10='pain as bad as you can imagine').
The study will involve four main study visits at the Walton Centre Trial Unit for assessment. Additionally, up to 10 short visits are required for safety monitoring, where we take blood to check for any side effects from Mycophenolate, as is standard with this drug treatment.
Participants will be randomised into 2 treatment groups (active and control). Both groups will be on active treatment for 5 and 1/2 months, followed by 5 and 1/2 months on standard treatment. Additionally the control group will have 5 and 1/2 months of standard treatment before they begin active treatment. Participants in the active group will be in the study for <1 year and those in the control group will be in the study for approx. 17 months.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0135
Date of REC Opinion
27 Apr 2015
REC opinion
Further Information Favourable Opinion