EUCTR2015-001195-21-NO
Active, Not Recruiting
N/A
oTOPainNovel Treatment Option for neuropathic PainA randomized, cross-over, placebo-controlled, double-blind, single-center, phase II study of cetuximab in patients with treatment-refractory, non-malignant severe chronic neuropathic pain.
Sørlandet Hospital0 sitesJuly 8, 2015
DrugsErbitux
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sørlandet Hospital
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All of the following conditions must apply for inclusion:
- •Signed informed consent and anticipated compliance with the treatment and study follow\-up according to ICH GCP, and national/local regulations.
- •Pain defined as definite” neuropathic pain, according to the Special Interest Group on Neuropathic Pain (NeuPSIG) guidelines or defined as probable” NP, according to the NeuPSIG guidelines, if the confirmatory test (see figure 2\) was a positive diagnostic test, i.e. positive finding on radiologic or neurophysiological testing. Complex regional pain syndrome (CRPS) can be included despite lack of an offending lesion, as long as the Budapest criteria”1 are fulfilled:
- •Clinical diagnostic criteria for complex regional pain syndrome
- •1\) Continuing pain, which is disproportionate to any inciting event
- •2\) Must report at least one symptom in three of the four following categories:
- •Sensory: Reports of hyperalgesia and/or allodynia
- •Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
- •Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
- •Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
Exclusion Criteria
- •Patients will be excluded from the study if they meet any of the following criteria:
- •Neuropathic pain origin in the central nervous system.
- •Phantom limb pain or a significant component of nociceptive pain.
- •Ascending distal small fiber peripheral neuropathy.
- •Patients primarily experiencing pain ‘attacks’, i.e. pattern of neuropathic pain depicted in picture 3 of the painDETECT scheme.
- •Other pain state that may interfere with evaluation of the studied neuropathic pain condition.
- •Any underlying medical or psychiatric condition, clinical disorder or laboratory finding, which in the opinion of the investigator may interfere with study objectives.
- •Uncontrolled or unstable diabetes.
- •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
- •Severe cerebrovascular disease during the six months prior to inclusion.
Outcomes
Primary Outcomes
Not specified
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