Trial | NCT02820519  Report issue

Official Title

Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    loxapine ...

  • Study Participants

    4
Loxapine is an antipsychotic drug approved for the treatment of schizophrenia in several countries including the United States. In animal studies in mice, loxapine reduced neuropathic pain. Hence, in a proof-of-principle and dose-escalating study the tolerability and analgesic efficacy of loxapine will be evaluated in patients with neuropathic pain.
In this dose-escalating study, 12 patients with refractory, chemotherapy-induced neuropathic pain (including mixed pain) will receive loxapine during four 14-days treatment episodes. The dosage for episode 1 (Days 1-14) will be 10 mg b.i.d., dosages for episodes 2, 3, and 4 will be defined by taking into account tolerability and analgesic efficacy of the former episode. In case of an acceptable tolerability and if a clinically relevant analgesic efficacy is not reached, loxapine dosage will be increased (2nd Episode 10 mg t.i.d, 3rd Episode 20 mg b.i.d., 4th episode 20 mg t.i.d.). In case of an acceptable tolerability and if a clinically relevant analgesic efficacy is reached, loxapine dosage will not be changed. If clinically relevant (serious) adverse events ((S)AEs) occur, loxapine dosage will be reduced or the treatment will be interrupted or stopped irrespective of the analgesic efficacy. A clinically relevant pain reduction / analgesic efficacy is defined by an at least 30% decrease or an absolute decrease of two scale units compared to baseline using 11-point numeric pain rating scale. Patients will receive loxapine as add-on treatment to their usual (analgesic) care.
Study Started
Jun 07
2016
Primary Completion
May 04
2017
Study Completion
May 04
2017
Last Update
Jul 01
2022

Drug Loxapine

Loxapine dose escalation according to tolerability and analgesic efficacy

  • Other names: Loxapine Succinate

Loxapine Experimental

Loxapine Capsules 10 mg Day 1- 14: 10 mg b.i.d Day 15-28: 10 mg t.i.d Day 29-42: 20 mg b.i.d. Day 43-56: 20 mg t.i.d. Dosages will be escalated according to analgesic efficacy and tolerability.

Criteria 

Inclusion Criteria:

Primarily chemotherapy-induced neuropathic pain (including mixed pain) for at least 3 months refractory to at least one analgesic compound
Neuropathic pain >= 4 (11-point numeric pain scale) at screening visit (including mixed pain)
Age >= 18 years
Body weight between 50 and 150 kg
Given written informed consent

Exclusion Criteria:

Participation in other interventional clinical studies (currently 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, malignancies with a life expectancy of less than 6 months, breast cancer in history, other life-threatening conditions
Corrected QT interval (QTc) > 460 ms (females) or > 450 ms (males)
Known alcohol and/or drug abuse
Concomitant intake of antipsychotics, dopamine agonists (Levodopa, bromocriptine, lisuride, pergolide, ropinirole, cabergoline, pramipexole, apomorphine), alpha-receptor blocking compounds
Compounds with a strong evidence for a clinically relevant QT interval prolongation or torsade de pointes risk increase
Strong inhibitors of CYP1A2, CYP2D6, or CYP3A4
Known CYP2D6 Poor metabolizer status
Pregnancy or lactation period
Missing or insufficient contraception in pre- or perimenopausal women
Close Affiliation with the investigational site
No Results Posted