NeuralgiaPhase 2NoTOPainNCT02490436
Novel Treatment Option for Neuropathic Pain
A Phase 2 study testing Cetuximab in people with Neuralgia and Complex Regional Pain Syndromes, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Complex Regional Pain Syndromes
- What is being tested?
- Cetuximab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Center for Cancer Treatment, Sorlandet Hospital HF
Kristiansand, 4604
About this study
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
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
- Being tested
- Cetuximab, Placebo
- Medical subject headings
- Neuralgia, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Randomized cross-over between cetuximab and placebo
PlaceboDrug
Randomized cross-over between cetuximab and placebo
| Study group | Role | What they receive |
|---|---|---|
| A: active drug first | Experimental | Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3. Receives: 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. Receives: Drug: Cetuximab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average neuropathic pain score using an 11-point numeric rating scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 4-8 after each infusion of cetuximab and placebo
Patient Global Impression of Change.
Measured: 7 days after each infusion.
Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
Measured: Days 4-8 after each infusion during treatment periods 1 and 2.
Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
Measured: 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.
Measured: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
Number of AE and SAE recording
Measured: From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Frontier Science & Technology Research Foundation, Inc., Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Christian Kersten, MD PhD, Principal investigator, Center for Cancer Treatment, Sørlandet Hospital, Kristiansand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490436
- Sponsor's protocol ID
- SFK3 / 062202_281
- Other IDs
- 2015-001195-21, 2015/618/REK sør-øst D, 2015
- Acronym
- NoTOPain
- Status last verified
- Nov 2016
- First submitted
- 5 Jun 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31106835
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02490436
- Acronym / sponsor ID
- NoTOPain / SFK3 / 062202_281
- Conditions
- Neuralgia, Complex Regional Pain Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Frontier Science & Technology Research Foundation, Inc., Merck KGaA, Darmstadt, Germany
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: active drug first | Experimental | Drug: Cetuximab, Drug: PlaceboCetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3. |
| B: placebo first | Experimental | Drug: Cetuximab, Drug: PlaceboPlacebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: ErbituxRandomized cross-over between cetuximab and placebo | Drug | A: active drug first, B: placebo first |
| PlaceboRandomized cross-over between cetuximab and placebo | Drug | A: active drug first, B: placebo first |
Primary outcome
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
10 secondary outcomes
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
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
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
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
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
Patient Global Impression of Change.
Time frame: 7 days after each infusion.
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.
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 31106835Kersten 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Kersten, MD PhD principal investigator
Center for Cancer Treatment, Sørlandet Hospital, Kristiansand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Neuralgia and Complex Regional Pain Syndromes, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.