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TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02031211
First received: January 7, 2014
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
CRPS
Chronic Regional Pain Syndrome
Drug: Etanercept
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Etanercept for the Treatment of Chronic Regional Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups.


Secondary Outcome Measures:
  • Adolescent Pediatric Pain Tool [ Time Frame: At end of each week of treatment ] [ Designated as safety issue: No ]
    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.

  • Skin Temperature and Volume of Affected Limb [ Time Frame: At beginning and end of study ] [ Designated as safety issue: No ]
    The skin temperature and volume of the affected limb will be measured at the beginning and end of the study.

  • Hospital Anxiety and Depression Scale [ Time Frame: Beginning and end of study ] [ Designated as safety issue: No ]
    The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study.

  • Sleep Disturbance Scale for Children [ Time Frame: Beginning and end of the study ] [ Designated as safety issue: No ]
    The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study.

  • Sleep pattern and quality [ Time Frame: Daily ] [ Designated as safety issue: No ]
    The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality.


Estimated Enrollment: 12
Study Start Date: June 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0.4 ml/kg of normal saline will be administered subcutaneously.
Drug: Placebo
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.
Other Name: Normal Saline
Experimental: Etanercept
Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.
Drug: Etanercept
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
Other Name: Enbrel

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031211

Contacts
Contact: Srinivas Naidu, MD snaiduz@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Srinivas Naidu, MD       snaiduz@stanford.edu   
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02031211     History of Changes
Other Study ID Numbers: 29290
Study First Received: January 7, 2014
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014