- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02490436
Novel Treatment Option for Neuropathic Pain (NoTOPain)
7. november 2016 oppdatert av: Sorlandet Hospital HF
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kristiansand, Norge, 4604
- Center for Cancer Treatment, Sorlandet Hospital HF
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: A: active drug first
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
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Randomized cross-over between cetuximab and placebo
Andre navn:
Randomized cross-over between cetuximab and placebo
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Eksperimentell: B: placebo first
Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.
|
Randomized cross-over between cetuximab and placebo
Andre navn:
Randomized cross-over between cetuximab and placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in average neuropathic pain score using an 11-point numeric rating scale.
Tidsramme: Days 4-8 after each infusion of cetuximab and placebo
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Days 4-8 after each infusion of cetuximab and placebo
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: Days 4-8 after each infusion of cetuximab and placebo
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Days 4-8 after each infusion of cetuximab and placebo
|
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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.
Tidsramme: Days 4-8 after each infusion of 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.
Tidsramme: Days 4-8 after each infusion of cetuximab and placebo
|
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.
Tidsramme: Days 4-8 after each infusion of cetuximab and placebo
|
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.
Tidsramme: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
|
Patient Global Impression of Change.
Tidsramme: 7 days after each infusion.
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7 days after each infusion.
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Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
Tidsramme: Days 4-8 after each infusion during treatment periods 1 and 2.
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Days 4-8 after each infusion during treatment periods 1 and 2.
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Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
Tidsramme: Days 4-8 after each infusion during treatment periods 1 and 2.
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Days 4-8 after each infusion during treatment periods 1 and 2.
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2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter.
Tidsramme: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
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2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
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Number of AE and SAE recording
Tidsramme: 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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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christian Kersten, MD PhD, Center for Cancer Treatment, Sørlandet Hospital, Kristiansand
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2015
Primær fullføring (Faktiske)
1. oktober 2016
Studiet fullført (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først innsendt
5. juni 2015
Først innsendt som oppfylte QC-kriteriene
2. juli 2015
Først lagt ut (Anslag)
3. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Smerte
- Nevrologiske manifestasjoner
- Nevromuskulære sykdommer
- Sykdommer i det perifere nervesystemet
- Sykdommer i det autonome nervesystemet
- Nevralgi
- Komplekse regionale smertesyndromer
- Refleks sympatisk dystrofi
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Cetuximab
Andre studie-ID-numre
- SFK3 / 062202_281
- 2015-001195-21 (EudraCT-nummer)
- 2015/618/REK sør-øst D (Annen identifikator: Regional Committees for Medical and Health Research Ethics)
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