Tolerability of Loxapine in patients with anti-cancer drug induced pai

Phase 1

• Conditions: Chemotherapy-induced neuropathic pain; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005440-17-DE
• Lead Sponsor: Private Universität Witten/Herdecke gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified