Chemotherapy-induced neuropathic pain
Conditions
Interventions
Trade Name: Loxapine Capsules 10 mg
Product Name: Loxapine Capsules 10 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Loxapine
CAS Number: 27833-64-3
Other descriptive name: LOXAPINE SUCCINATE
C
Sponsors
Private Universität Witten/Herdecke gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chemotherapy induced neuropathic pain of at least 3 months refractory to at least one analgesic compound - Neuropathic pain = 4 (11-point numeric pain rating scale) at screening visit (including mixed pain) - Age: =18 years - Body weight between 50 to 150 kg - Given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Participation in other interventional studies (current or within the last 3 months) - Parkinson’s disease, movement disorders (extrapyramidal signs and symptoms) associated with antipsychotics, Neuroleptic malignant syndrome, other syndromes associated with antipsychotics - Severe hypotension with a syncope in history, glaucoma, urinary retention, epilepsy or other seizure disorders in history, severe dementia, dementia related psychosis in history, breast cancer in medical history, malignancies with a life expectancy of less than 6 months, other severe and life-threatening diseases - Known drug or alcohol abuse - Concomitant intake of antipsychotics, dopamine agonists (levodopa, bromocriptine, lisuride, pergolide, ropinirole, cabergoline, pramipexole, apomorphine), alpha-receptor blocking compounds or compounds with a known potential for QT interval prolongation - Pregnancy or lactation period - Pre- or perimenopausal females with ineffective contraception - Close affiliation with the investigational site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tolerability of Loxapine in patients with chemotherapy-induced neuropathic pain;Secondary Objective: Analgesic efficacy of Loxapine in patients with chemotherapy-induced neuropathic pain;Primary end point(s): This pilot study is a safety study primarily evaluating the tolerability of Loxapine in non-psychiatric patients. The primary endpoint is defined as the first occurrence of a (serious) adverse event leading to dose reduction or withdrawal of Loxapine ("event"). The Loxapine dosage with the lowest incidence of events will be identified.;Timepoint(s) of evaluation of this end point: The primary endpoints will be analyzed after all planned patients have finished the study (no planned interim analyses). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Regarding tolerability, the following secondary safety variables will be analyzed: - Number, type, and severity of (serious) adverse events ((S)AEs) - Cumulative incidence rates for (S)AE pattern of study participants - Individual (study participant-related) incidence of individual (S)AEs Regarding efficacy, the following secondary variables will be analyzed: - Individual (study participant-related) changes in pain severity (measured by using a 11-point numeric pain rating scale) in relation to treatment phase and Loxapine dosage - Assessment of the association between the pattern of events (primary endpoint) related to the individual pain level (Clinically relevant pain reduction is defined by an at least 30% decrease or an absolute decrease of two scale units (measured by using 11-point numeric pain rating scale) - Individual (study participant-related) changes in pain severity / characteristics (measured by painDETECT questionnaire) in relation to treatment phase and Loxapine dosage - Assessment of the association between the pattern of events (primary endpoint) related to individual changes in pain severity / charcteristics (measured by painDETECT questionnaire) - Individual (study participant-related) changes in the quality of life (12-item Short Form Health Survey (SF-12v2)) in relation to treatment phase and Loxapine dosage - Assessment of the association between the pattern of events (primary endpoint) related to the individual quality of life changes ((12-item Short Form Health Survey (SF-12v2)) - Individual (study participant-related) changes in anxiety and depression (HADS-D scale)) in relation to treatment phase and Loxapine dosage - Assessment of the association between the pattern of events (primary endpoint) related to the individual changes in anxiety and depression (HADS-D scale) - Assessment of the association between the pattern of events (primary endpoint) related to the individual changes analgesic co-me | — |
Countries
Germany
Contacts
Public ContactPhilipp Klee-Institut
HELIOS Klinikum Wuppertal, Klinikum der Privaten Universität Witten/Herdecke
Outcome results
None listed