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Novel Treatment Option for Neuropathic Pain (NoTOPain)

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ClinicalTrials.gov Identifier: NCT02490436
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : November 8, 2016
Sponsor:
Collaborators:
Frontier Science & Technology Research Foundation, Inc.
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Sorlandet Hospital HF

Brief Summary:
The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.

Condition or disease Intervention/treatment Phase
Neuralgia Complex Regional Pain Syndromes Drug: Cetuximab Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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.
Drug: Cetuximab
Randomized cross-over between cetuximab and placebo
Other Name: Erbitux

Drug: Placebo
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.
Drug: Cetuximab
Randomized cross-over between cetuximab and placebo
Other Name: Erbitux

Drug: Placebo
Randomized cross-over between cetuximab and placebo




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Patient Global Impression of Change. [ Time Frame: 7 days after each infusion. ]
  7. 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. ]
  8. 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. ]
  9. 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). ]
  10. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490436


Locations
Norway
Center for Cancer Treatment, Sorlandet Hospital HF
Kristiansand, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Frontier Science & Technology Research Foundation, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Principal Investigator: Christian Kersten, MD PhD Center for Cancer Treatment, Sørlandet Hospital, Kristiansand

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT02490436     History of Changes
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 )
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Neuralgia
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Autonomic Nervous System Diseases
Cetuximab
Antineoplastic Agents