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Sleep in patients having neuropathic pai

Phase 1
Conditions
europathic pain
MedDRA version: 21.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852
MedDRA version: 21.1Level: LLTClassification code 10067547Term: Diabetic peripheral neuropathic painSystem Organ Class: 100000004852
MedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2020-001957-31-FI
Lead Sponsor
Eija Kalso
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
40
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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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