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Novel Treatment Option for Neuropathic Pain (NoTOPain)

7 novembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

15

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Kristiansand, Norvegia, 4604
        • Center for Cancer Treatment, Sorlandet Hospital HF

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: A: active drug first
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
Randomized cross-over between cetuximab and placebo
Altri nomi:
  • Erbitux
Randomized cross-over between cetuximab and placebo
Sperimentale: 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
Altri nomi:
  • Erbitux
Randomized cross-over between cetuximab and placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Change in average neuropathic pain score using an 11-point numeric rating scale.
Lasso di tempo: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 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 neuropathic pain score using an 11-point numeric rating scale.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 7 days after each infusion.
7 days after each infusion.
Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
Lasso di tempo: Days 4-8 after each infusion during treatment periods 1 and 2.
Days 4-8 after each infusion during treatment periods 1 and 2.
Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
Lasso di tempo: Days 4-8 after each infusion during treatment periods 1 and 2.
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.
Lasso di tempo: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
Number of AE and SAE recording
Lasso di tempo: From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Christian Kersten, MD PhD, Center for Cancer Treatment, Sørlandet Hospital, Kristiansand

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2015

Completamento primario (Effettivo)

1 ottobre 2016

Completamento dello studio (Effettivo)

1 ottobre 2016

Date di iscrizione allo studio

Primo inviato

5 giugno 2015

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2015

Primo Inserito (Stima)

3 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

8 novembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SFK3 / 062202_281
  • 2015-001195-21 (Numero EudraCT)
  • 2015/618/REK sør-øst D (Altro identificatore: Regional Committees for Medical and Health Research Ethics)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cetuximab

3
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