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Neuropathic PainPhase 2LOX2015PILOTNCT02820519

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

A Phase 2 study testing Loxapine in people with Neuropathic Pain, run by University of Witten/Herdecke at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
What is being tested?
Loxapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteGermany
Study dates
7 Jun 2016to 4 May 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • HELIOS Clinic Wuppertal

    Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

About this study

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.

Read the detailed description

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.

Being tested
Loxapine
Keywords
Neuropathic pain, Loxapine, Antipsychotics, Co-Analgesics, Tolerability, Analgesic efficacy
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LoxapineDrug

    Also called Loxapine Succinate

    Loxapine dose escalation according to tolerability and analgesic efficacy

Study groups in NCT02820519
Study groupRoleWhat they receive
LoxapineExperimentalLoxapine 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.
Receives: Drug: Loxapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loxapine dosage with the lowest incidence of events.

    The primary endpoint is defined as the first occurrence of a (serious) adverse event ((S)AE) leading to dose reduction or withdrawal of loxapine ("event"). The loxapine dosage with the lowest incidence of events will be identified.

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

Secondary outcomes (12)

  1. Number, type, and severity of (serious) adverse events ((S)AEs)

    Number, type, and severity of (serious) adverse events ((S)AEs)

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  2. Cumulative incidence rates for (S)AE pattern of study participants

    Cumulative incidence rates for (S)AE pattern of study participants

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  3. Individual (study participant-related) incidence of individual (S)AEs

    Individual (study participant-related) incidence of individual (S)AEs

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  4. Individual (study participant-related) changes in pain severity (NRS scale)

    Individual (study participant-related) changes in pain severity (measured by using 11-point numeric pain rating scale) in relation to treatment phase and loxapine dosage

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  5. Association between event pattern and individual pain level (NRS scale)

    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 compared to baseline using 11-point numeric pain rating scale.

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  6. Individual (study participant-related) changes in pain severity (painDETECT)

    Individual (study participant-related) changes in pain severity (measured by painDETECT questionnaire) in relation to treatment phase and loxapine dosage

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  7. Association between event pattern and individual pain level (painDETECT)

    Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in pain severity / characteristics measured by painDETECT questionnaire

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  8. Individual (study participant-related) changes in QoL (SF-12v2)

    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

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  9. Association between event pattern and QoL (SF-12v2)

    Assessment of the association between the pattern of events (Primary endpoint) related to the individual quality of life changes changes (12-item Short Form Health Survey (SF-12v2))

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  10. Individual (study participant-related) changes in anxiety and depression (HADS-D scale)

    Individual (study participant-related) changes in anxiety and depression (HADS-D scale) in relation to treatment phase and loxapine dosage

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  11. Association between event pattern and anxiety and depression (HADS-D scale)

    Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in anxiety and depression (HADS-D scale)

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

  12. Association between event pattern and analgesic co-medication

    Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in analgesic co-medication

    Measured: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study start7 Jun 2016
  3. Primary completion4 May 2017
  4. Study completion4 May 2017

Why it stopped: Intolerable high amount of adverse events

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820519
Sponsor's protocol ID
LOX_2015_PILOT
Other IDs
2014-005440-17, 2014
Acronym
LOX2015PILOT
Status last verified
Aug 2017
First submitted
14 Jun 2016
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Schmiedl S, Peters D, Schmalz O, Mielke A, Rossmanith T, Diop S, Piefke M, Thurmann P, Schmidtko A. Loxapine for Treatment of Patients With Refractory, Chemotherapy-Induced Neuropathic Pain: A Prematurely Terminated Pilot Study Showing Efficacy But Limited Tolerability. Front Pharmacol. 2019 Jul 25;10:838. doi: 10.3389/fphar.2019.00838. eCollection 2019.

    PubMed 31402867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Loxapine in people with Neuropathic Pain, run by University of Witten/Herdecke at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Intolerable high amount of adverse events). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loxapine dosage with the lowest incidence of events. (time frame: After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820519, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

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