Mycophenolate Treatment for Longstanding Complex Regional Pain Syndrome (MYPS I)

• Conditions: Complex Regional Pain Syndrome (CRPS); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-000263-14-GB
• Lead Sponsor: Walton Centre NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.Diagnosis of Complex Regional Pain Syndrome I or II according to Budapest research criteria (appendix 2)
2.Disease duration of >2 years, and a mean pain intensity on an 11-point (0-10) Numeric Rating Scale (NRS) over the first fourteen daily entries after screening of 5 or higher (and no single daily pain intensity value below 5, a minimum of 13 valid scores need to be available).
3.Failure to respond (poor efficacy or unacceptable side effects) to drugs recommended for the treatment of neuropathic pain, including pregabalin or gabapentin, a tricyclic antidepressant, and mild and strong opioids (where not contraindicated or refused by the patient).
4.Previous pain-physiotherapy (where not contraindicated or refused)
5.Willingness to confirm the use of adequate birth control while on the trial will be required in pre-menopausal women without evidence for an inability to become pregnant.
6.Willingness to not start any other treatment for CRPS until the end of active treatment.
7.Age 18 years and above.
8.Blood antibodies against varicella zoster confirming immunity against varicella infection (expected present in 90% of the population), to mitigate the risk of new varicella injection under immunosuppression.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1.Other significant chronic pains, which in the view of the study doctor may make assessment of the pain arising from CRPS difficult.
2.If the patient recently started a new therapy for CRPS, which in the view of the study doctor may change the patient’s pain level during the time of participation in the trial.
3.Unstable medical conditions.
4.Pregnant or breastfeeding patients.
5.Receiving mycophenolate for other reasons, or previously tried mycophenolate.
6.Concomitant systemic treatment with other immunosuppressant drugs.
7.Ongoing drug or alcohol misuse.
8.Psychiatric or mental health disorder, which could in the judgment of the study doctor interfere with successful study participation.
9.Unwillingness or inability to complete daily diaries, or inability to understand the questionnaires being used.
10.Cancer other than basal cell carcinoma within the last 5 years. However those patients who have received definite treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
11.Specific contraindications to mycophenolate.
12.Renal failure or serum creatinine greater than 1.5 times the upper limit of normal at screening.
13.Liver failure, any blood dyscresia.
14.Any medical condition, which in the opinion of the investigator would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.
15.Participation in another interventional trial within 3 month before randomization. Participation in non-interventional studies is not a reason for exclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified