Terbutaline for the treament of painful neuropathy

The beta-2-agonist terbutaline for the treatment of painful polyneuropathy. A randomised, active- and placebo-controlled trial - Terbutaline for the treament of painful polyneuropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002984-40-DK

Enrollment

Registered

2015-08-10

Start date

2015-09-25

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful polyneuropathy MedDRA version: 18.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852

Interventions

Trade Name: Bricanyl Retard 5 mg Pharmaceutical Form: Capsule INN or Proposed INN: TERBUTALINE SULFATE CAS Number: 23031-32-5 Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age over 18 years - pain due to polyneuropathy for more than 3 months - pain score 4 or higher on 0-10 point numeric rating scale 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: - other sgnificant pain condition - other significant neurological or psychiatric disease - known allergic reactions or other significant adverse events on the study drugs - significant heart, lung, kidney or liver disease - treatment with drugs that interact significantly with the study drugs

Design outcomes

Primary

Measure	Time frame
Secondary Objective: - to determine if terbutaline is as efficacious in painful polyneuropathy as imipramine - to determine if terbutaline relieves specific pain symptoms in polyneuropathy - to determine if terbutaline relieves pain related sleep disturbance in polyneuropathy;Primary end point(s): The primary end point wil be numeric rating of total pain on 0-10 point numeric rating scales with daily scores converted to a median for each week.;Timepoint(s) of evaluation of this end point: All weekly score medians from the 5 week treatment periods and the baseline periods will go into the statistical analysis (general linear model).;Main Objective: The objective of the trial is to determine if terbutaline relieves pain in polyneuropathy.	—

Measure

Time frame

Secondary Objective: - to determine if terbutaline is as efficacious in painful polyneuropathy as imipramine - to determine if terbutaline relieves specific pain symptoms in polyneuropathy - to determine if terbutaline relieves pain related sleep disturbance in polyneuropathy;Primary end point(s): The primary end point wil be numeric rating of total pain on 0-10 point numeric rating scales with daily scores converted to a median for each week.;Timepoint(s) of evaluation of this end point: All weekly score medians from the 5 week treatment periods and the baseline periods will go into the statistical analysis (general linear model).;Main Objective: The objective of the trial is to determine if terbutaline relieves pain in polyneuropathy.

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Secondary

Measure	Time frame
Secondary end point(s): - numeric rating 0-10 points of specific pain symptoms - numeric rating 0-10 points of pain related sleep disturbance - Patient Global Impression of Change (PGIC);Timepoint(s) of evaluation of this end point: Numeric scores of specific pain symptoms and sleep disturbance as for the primary end point and PGIC after each treatment period.	—

Countries

Denmark

Contacts

Public ContactNeuromuscular Team

Odense University Hospital

soeren.sindrup@rsyd.dk4565412471

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026