Randomised, double-blind, placebo-controlled trial of the effect of the combination of imipramine and pregabalin for the treatment of painful polyneuropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013642-80-DK

Enrollment

Registered

2009-08-03

Start date

2009-09-30

Completion date

Unknown

Last updated

2021-04-19

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

Conditions

Painful polyneuropathy (idiopathic, diabetic, alcoholic, drug-induced and other etiologies) MedDRA version: 12.0 Level: LLT Classification code 10036105 Term: Polyneuropathy

Interventions

Trade Name: Lyrica Pharmaceutical Form: Capsule, hard INN or Proposed INN: pregabalin CAS Number: 148553-50-8 Other descriptive name: PREGABALIN Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 20-85 years 2. Polyneuropathy diagnosis confirmed by nerve conduction studies 3. Polyneuropathic pain symptoms for at least 6 months 4. Average baseline pain score of at least 4 on a 0-10 numeric rating scale 5. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Additional cause of pain 2. Allergic reactions towards imipramin or pregabalin 3. Contraindikations towards imipramin 4. Pregnancy or breast feeding period 5. Severe illness 6. Treatment with antidepressants, anticonvulsants, opioids, antipsycotics or monoamin oxidase inhibitors.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if the combination of imipramin and pregabalin relieves painful polyneuropathy better than monotherapy with each of the drugs.;Secondary Objective: To determine if the combination provides relief of specific pain symptoms, improves quality of life and reduces pain-induced sleep disturbance. ;Primary end point(s): Patient mean ratings of total pain on a 0-10 point numerical rating scale during the last week of each treatment period.	—

Measure

Time frame

Main Objective: To determine if the combination of imipramin and pregabalin relieves painful polyneuropathy better than monotherapy with each of the drugs.;Secondary Objective: To determine if the combination provides relief of specific pain symptoms, improves quality of life and reduces pain-induced sleep disturbance. ;Primary end point(s): Patient mean ratings of total pain on a 0-10 point numerical rating scale during the last week of each treatment period.

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Countries

Denmark

Outcome results

None listed

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