Novel Treatment Option for Neuropathic Pain

NCT02490436 | Completed Phase 2 DMC

• 3 other identifiers: SFK3 / 062202_2812015-001195-212015/618/REK sør-øst D
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in average neuropathic pain score using an 11-point numeric rating scale.

  Days 4-8 after each infusion of cetuximab and placebo

Secondary Outcomes (10)

• 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.

  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

Study Arms (2)

A: active drug first

EXPERIMENTAL

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

Drug: Cetuximab; Drug: Placebo

B: placebo first

EXPERIMENTAL

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

Drug: Cetuximab; Drug: Placebo

Interventions

Cetuximab DRUG

Randomized cross-over between cetuximab and placebo

Also known as: Erbitux

A: active drug first; B: placebo first

Placebo DRUG

Randomized cross-over between cetuximab and placebo

A: active drug first; B: placebo first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged 18 or above

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• Frontier Science & Technology Research Foundation, Inc.: collaborator
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Center for Cancer Treatment, Sorlandet Hospital HF

Kristiansand, 4604, Norway

Location

Related Publications (1)

• 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.

  PMID: 31106835 DERIVED

MeSH Terms

Conditions

Neuralgia; Complex Regional Pain Syndromes

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christian Kersten, MD PhD

  Center for Cancer Treatment, Sørlandet Hospital, Kristiansand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: July 3, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

NO (1)