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

• Status: Terminated
• Trial end date: 2017-07-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Witten/Herdecke
• Treatments: Analgesics; Loxapine

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