Novel Treatment Option for Neuropathic Pain

NCT ID: NCT02490436

Last Updated: 2016-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Neuralgia; Complex Regional Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A: active drug first

Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Randomized cross-over between cetuximab and placebo

Placebo

Intervention Type: DRUG

Randomized cross-over between cetuximab and placebo

B: placebo first

Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Randomized cross-over between cetuximab and placebo

Placebo

Intervention Type: DRUG

Randomized cross-over between cetuximab and placebo

Interventions

Cetuximab

Randomized cross-over between cetuximab and placebo

Intervention Type: DRUG

Placebo

Randomized cross-over between cetuximab and placebo

Intervention Type: DRUG

Other Intervention Names

Erbitux

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frontier Science & Technology Research Foundation, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Kersten, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Cancer Treatment, Sørlandet Hospital, Kristiansand

Locations

Center for Cancer Treatment, Sorlandet Hospital HF

Kristiansand, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 31106835 (View on PubMed)

Other Identifiers

2015-001195-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2015/618/REK sør-øst D

Identifier Type: OTHER

Identifier Source: secondary_id

SFK3 / 062202_281

Identifier Type: -

Identifier Source: org_study_id