The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
Adverse events reported spontaneously by the subject or observed by the investigator
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes laboratory, ECG and vital signs parameters.
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes in physical or neurological examination findings
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Subject withdrawal due to adverse events
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.
Time frame: Daily assessment during entire trial participation including assessments at site visits
Within-subject change in average pain score: Daily assessments throughout the trial
Time frame: Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of different neuropathic pain qualities during specific site visit
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Time frame: Daily assessment during entire trial participation including assessments at site visits
Time to exit (days) de to lack of efficacy of treatment
Time frame: Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of sleep and activity throughout the trial, daily assessments
Time frame: Daily assessment during entire trial participation including assessments at site visits
Patient's Global Impression of Change in Pain (PGIC) during specific site visit
Time frame: Daily assessment during entire trial participation including assessments at site visits
Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit
Time frame: Daily assessment during entire trial participation including assessments at site visits
Quality of life assessments during specific site visits
Time frame: Daily assessment during entire trial participation including assessments at site visits