TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

CRPS Clinical Trial

Official title:

Etanercept for the Treatment of Chronic Regional Pain Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02031211
• Other study ID #: 29290
• Status: Withdrawn
• Phase: N/A
• First received: January 7, 2014
• Last updated: October 12, 2016
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.

2. Patients must meet CRPS Type I diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb =1.0°C.

3. Duration of symptoms less than 4 months.

Exclusion Criteria:

1. Active malignancy or history of malignancy.

2. Active infection.

3. History of Tuberculosis (TB) or TB exposure.

4. Pregnancy.

5. Concomitant disease causing immunocompromise.

6. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.

7. Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.

8. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine = 150% normal value for age.

9. Evidence of or history of demyelinating disease.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Regional Pain Syndrome
• CRPS
• Syndrome

Intervention

Drug:
• Etanercept
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
• Placebo
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups.	8 weeks	No
Secondary	Adolescent Pediatric Pain Tool	The Adolescent Pediatric Pain Tool is a survey that will be administered at baseline and at the end of each of the four weeks of treatment.	At end of each week of treatment	No
Secondary	Skin Temperature and Volume of Affected Limb	The skin temperature and volume of the affected limb will be measured at the beginning and end of the study.	At beginning and end of study	No
Secondary	Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study.	Beginning and end of study	No
Secondary	Sleep Disturbance Scale for Children	The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study.	Beginning and end of the study	No
Secondary	Sleep pattern and quality	The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality.	Daily	No