- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490436
Novel Treatment Option for Neuropathic Pain (NoTOPain)
November 7, 2016 updated by: Sorlandet Hospital HF
A 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
The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kristiansand, Norway, 4604
- Center for Cancer Treatment, Sorlandet Hospital HF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent and anticipated compliance.
- Pain defined as "definite" neuropathic pain, according to the Special Interest Group on Neuropathic Pain guidelines or defined as "probable" NP, according to the guidelines, if the confirmatory test was a positive diagnostic test. Complex regional pain syndrome can be included despite lack of an offending lesion, as long as the "Budapest criteria" are fulfilled
- Neuropathic Pain associated with compressive nerve states (including failed surgery) or CRPS (according to the "Budapest criteria")
- PainDETECT score of at least 13 with average pain intensity of at least 6 /10 over the last four weeks. In addition, a painDETECT pattern indicating that the underlying neuropathic pain is constantly present.
- Worst pain intensity higher than 6 for five of seven days during the screening phase, according to Brif Pain Inventory.
- The patient should be able to distinguish between the neuropathic pain and other pain conditions, including elements of nociceptive pain caused by the same disease process.
- Neuropathic pain duration of between six and thirty months, deemed chronic and likely to be irreversible by clinical history and findings.
- No new or increased neuropathic pain treatment for the last four weeks.
- Standard medical treatments for the patients' underlying condition or neuropathic pain must have been considered or tried and must, according to the opinion of the referring or a consulted pain specialist, be judged to be inappropriate or of insufficient potential efficacy.
- Referring physician agreement to follow up the patient after study completion according to the best possible and available pain treatment and care.
- Women of childbearing potential and men must use an acceptable method of contraception throughout the study, and for 30 days after the last study drug administration.
- Negative pregnancy test within 7 days before each treatment period where appropriate.
- White blood cell count ≥ 3 × 109 with neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL). Total bilirubin ≤ 1.5 × upper limit of reference range and AST and ALT ≤ 2.5 × upper limit of reference range within the last 28 days before inclusion.
- Aged 18 or above
Exclusion 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.
- 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.
- Active and ongoing eye and skin disorders or newly diagnosed gastric ulcer that may interfere with the study treatment.
- History of allergic reaction to any of the study treatment components, red meat or tick bites.
- Previous treatment with any EGFR-pathway inhibitor.
- Women who are pregnant or breastfeeding.
- Participation in another clinical trial within the past 90 days.
- Use of any investigational agent within 90 days prior to day 1 of study drug.
- Known drug abuse/alcohol abuse, legal incapacity or limited legal capacity or any other reason that, in the opinion of the investigator precludes the subject from participating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A: active drug first
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
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Randomized cross-over between cetuximab and placebo
Other Names:
Randomized cross-over between cetuximab and placebo
|
Experimental: B: placebo first
Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.
|
Randomized cross-over between cetuximab and placebo
Other Names:
Randomized cross-over between cetuximab and placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average neuropathic pain score using an 11-point numeric rating scale.
Time Frame: Days 4-8 after each infusion of cetuximab and placebo
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Days 4-8 after each infusion of cetuximab and placebo
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average neuropathic pain score using an 11-point numeric rating scale.
Time Frame: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average neuropathic pain score using an 11-point numeric rating scale.
Time Frame: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
Comparison of change in average worst neuropathic pain score using an 11-point numeric rating scale.
Time Frame: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
Time Frame: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
Time Frame: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
Patient Global Impression of Change.
Time Frame: 7 days after each infusion.
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7 days after each infusion.
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Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
Time Frame: Days 4-8 after each infusion during treatment periods 1 and 2.
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Days 4-8 after each infusion during treatment periods 1 and 2.
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Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
Time Frame: Days 4-8 after each infusion during treatment periods 1 and 2.
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Days 4-8 after each infusion during treatment periods 1 and 2.
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2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter.
Time Frame: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
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2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
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Number of AE and SAE recording
Time Frame: From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
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From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Kersten, MD PhD, Center for Cancer Treatment, Sørlandet Hospital, Kristiansand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
June 5, 2015
First Submitted That Met QC Criteria
July 2, 2015
First Posted (Estimate)
July 3, 2015
Study Record Updates
Last Update Posted (Estimate)
November 8, 2016
Last Update Submitted That Met QC Criteria
November 7, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFK3 / 062202_281
- 2015-001195-21 (EudraCT Number)
- 2015/618/REK sør-øst D (Other Identifier: Regional Committees for Medical and Health Research Ethics)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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