Clinical trial • Phase IV • Neurology

Pregabalin for Peripheral neuropathic pain

Phase IV trial of Pregabalin for Peripheral neuropathic pain. 40 participants.

Overview

Phase IV trial across 2 sites in Finland.

Recruits 40 No vulnerable population selected; participants are adults (age 18-75)..

Vulnerable Population: No vulnerable population selected; participants are adults (age 18-75).

{"criterion_text":"-Patients with peripheral painful neuropathy, age 18-75 years, pain is chronic (duration >3 months) and moderate to severe intensity (NRS ≥ 4/10) aiming to recruit 20 patients with at least a moderate sleep disturbance as assessed with ISI-questionnaire (>14) and 20 patients without sleep disturbance."}

{"criterion_text":"-Excessive alcohol consumption (>7 doses/week). If the patient uses gabapentinoids (gabapentin or pregabalin), they are discontinued 2 weeks before the study. Psychotic depression, clinically significant bipolar disorder. Contraindications to brain fMRI."}

{"endpoint_text":"-Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale","definition_or_measurement_approach":"Pain intensity and interference assessed by numeric rating scale"}

{"endpoint_text":"-Pregabalin effect on sleep stages. 1-night Ambulatory Polysomnography (NREM stage III).","definition_or_measurement_approach":"1-night Ambulatory Polysomnography (NREM stage III)"}
{"endpoint_text":"-Sleep disturbance associations to brain network connectivity. Brain fMRI for brain network connectivity","definition_or_measurement_approach":"Brain fMRI for brain network connectivity"}
{"endpoint_text":"-Sleep disturbance associations to choroid plexus volume in brain fMRI. Brain fMRI for choroid plexus volume measures","definition_or_measurement_approach":"Brain fMRI for choroid plexus volume measures"}
{"endpoint_text":"-Pregabalin effect on circadian rhythms. 1-week actigraphy and OURA-ring","definition_or_measurement_approach":"1-week actigraphy and OURA-ring to assess circadian rhythms"}
{"endpoint_text":"-Pregabalin effect on body temperature during sleep. 1-night body temperature measurement by iButton","definition_or_measurement_approach":"1-night body temperature measurement by iButton"}

Planned Sample Size: 40
Recruitment Window Months: 37
Consent Approach: Informed consent obtained from adult participants; a Subject information and informed consent form is listed among study documents.

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