ow-dose Intravenous Immunoglobulin Treatment for Complex Regional Pain Syndrome (LIPS Trials)

Phase 1

• Conditions: Complex Regional Pain Syndrome; MedDRA version: 14.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2012-000058-73-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-03
• Study Completion: 2016-03-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 111

Inclusion Criteria

1.Diagnosis of Complex Regional Pain Syndrome I or II according to Budapest research criteria (appendix 5) (22).
2.Disease duration of 1-5 years and a mean pain intensity on an 11-point (0-10) Numeric Rating Scale (NRS) over the first seven daily entries after screening within a pre-defined range (see section 9 for details of pain thresholds for eligibility)
3.Failure to respond (poor efficacy or unacceptable side effects) to drugs recommended for the treatment of neuropathic pain (23), including pregabalin or gabapentin, a tricyclic antidepressant, and mild and strong opioids (where not contraindicated or refused by the patient).
4.Previous specialised pain physiotherapy (24), including desensitisation techniques, and either mirror therapy (25) or graded motor imagery treatment (26), or both (where not contraindicated or refused by the patient).
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 during the parallel part of the trial
7.Age 18 years and above

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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Any individuals meeting any of the following will be excluded from the study:
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.Litigation. Patients in litigation will be excluded only if conclusion of that litigation is imminent during the course of the study.
5.Pregnant or breastfeeding patients.
6.Complete IgA deficiency
7.Rare contraindications to IVIg therapy as per summary of product characteristics (SmPC)
8.Receiving IVIg for other reasons,
9.Patients previously enrolled in CRPS IVIg/SCIG trials
10.Drugs or alcohol abuse
11.Psychiatric or mental health disorder which could in the judgement of the site investigator interfere with successful study participation
12.Unwillingness or inability to complete daily diaries, or inability to understand the questionnaires being used.
13.Cancer other than basal cell carcinoma within the last 5 years. However those patients who have received definitive treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
14.A history of hypercoagulable or thrombophilic clotting abnormalities.
15.A history of thrombembolic events: ischaemic stroke, confirmed myocardial infarction, pulmonary embolism; deep venous thrombosis except where immobility related (e.g. after injury or operation).
16.Unstable angina.
17. Renal failure, or serum creatinine greater than 1.5 times the upper limit of normal at screening.
18.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.
19.Participation in another interventional trial within 3 months of randomisation. 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