Sleep in patients having neuropathic pain

Sleep and neuropathic pain: Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effects of pregabalin on sleep and pain - SLEEPNEUROPAIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001957-31-FI

Enrollment

Registered

2021-06-22

Start date

2021-07-06

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Neuropathic pain MedDRA version: 21.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852 MedDRA version: 21.1 Level: LLT Classification code 10067547 Term: Diabetic peripheral neuropathic pain System Organ Class: 100000004852 MedDRA version: 20.0 Level: LLT Classification code 10077974 Term: Peripheral neuropathic pain System Organ Class: 100000004852

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 18-75 yrs, neuropathic pain for >3 months, numerical rating scale intensity for pain 5 or more on a 10 point scale, sleep disturbance >14 in 50% of the patients 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: Major psychiatric condition, inability to fill in the questionnaires in Finnish, drugs that affect sleep

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effects or pregabalin in neuropathic pain and sleep. The question is: does pregabalin provide better relief in patients who have a relevant sleep problem in addition to neuropathic pain compared with those who do not have a sleep problem.;Secondary Objective: What is the effect of pregabalin on the sleep structure of patients who have neuropathic pain;Primary end point(s): Mean pain interference during the previous week as assessed when the drug has been on a stable dose for a month, compared with baseline;Timepoint(s) of evaluation of this end point: The week before treatment is started vs. the last week once the treatment has been on a stable dose for a month	—

Measure

Time frame

Main Objective: To study the effects or pregabalin in neuropathic pain and sleep. The question is: does pregabalin provide better relief in patients who have a relevant sleep problem in addition to neuropathic pain compared with those who do not have a sleep problem.;Secondary Objective: What is the effect of pregabalin on the sleep structure of patients who have neuropathic pain;Primary end point(s): Mean pain interference during the previous week as assessed when the drug has been on a stable dose for a month, compared with baseline;Timepoint(s) of evaluation of this end point: The week before treatment is started vs. the last week once the treatment has been on a stable dose for a month

—

Secondary

Measure	Time frame
Secondary end point(s): Sleep on the ISI questionnaire during the previous week as assessed when the drug has been on a stable dose for a month, compared with baseline;Timepoint(s) of evaluation of this end point: The week before treatment is started vs. the last week once the treatment has been on a stable dose for a month	—

Countries

Finland

Contacts

Public ContactEija Kalso

Eija Kalso

eija.kalso@hus.fi

Outcome results

None listed

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