Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01202227
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for subjects to be shifted from Study A0081107
* Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
* Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);
Inclusion criteria for subjects to be new participants in this study
* Subjects with central neuropathic pain after stroke or multiple sclerosis;
* At least 6 months have passed after the onset of central neuropathic pain;
* Pain VAS at least 40mm in Visit 1 and Visit 2;
Exclusion Criteria:
* Creatinine clearance \< 60 mL/min;
* Platelet count \< 100 × 103/mm3 ; White blood cell (WBC) count \< 2500 / mm3; Neutrophil count \< 1500/ mm3;
* Subjects who are expected to require surgery during the trial;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01202227
Study Brief:
Protocol Section:
NCT01202227