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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001195-21 | EudraCT Number | ||
| 2015/618/REK sør-øst D | Other Identifier | Regional Committees for Medical and Health Research Ethics |
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| Name | Class |
|---|---|
| Frontier Science & Technology Research Foundation, Inc. | INDUSTRY |
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: active drug first | Experimental | Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3. |
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| B: placebo first | Experimental | Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | Randomized cross-over between cetuximab and placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in average neuropathic pain score using an 11-point numeric rating scale. | Days 4-8 after each infusion of cetuximab and placebo |
| Measure | Description | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Kersten, MD PhD | Center for Cancer Treatment, Sørlandet Hospital, Kristiansand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cancer Treatment, Sorlandet Hospital HF | Kristiansand | 4604 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31106835 | Derived | Kersten C, Cameron MG, Bailey AG, Fallon MT, Laird BJ, Paterson V, Mitchell R, Fleetwood-Walker SM, Daly F, Mjaland S. Relief of Neuropathic Pain Through Epidermal Growth Factor Receptor Inhibition: A Randomized Proof-of-Concept Trial. Pain Med. 2019 Dec 1;20(12):2495-2505. doi: 10.1093/pm/pnz101. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | Randomized cross-over between 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. | 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. | 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. | Days 4-8 after each infusion of cetuximab and placebo |
| Patient Global Impression of Change. | 7 days after each infusion. |
| Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo. | Days 4-8 after each infusion during treatment periods 1 and 2. |
| Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo. | Days 4-8 after each infusion during treatment periods 1 and 2. |
| 2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter. | 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86). |
| Number of AE and SAE recording | From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |