Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160082
Status:
COMPLETED
Last Update Posted:
2007-04-03
First Post:
2005-09-09
Brief Title:
Efficacy and Safety of Xepol Human Immunoglobulin in Subjects With Post-Polio Syndrome PPS
Sponsor:
Calliditas Therapeutics AB
Organization:
Calliditas Therapeutics AB
Study Overview
Official Title:
Efficacy and Safety of Xepol Human Immunoglobulin in Subjects With Post-Polio Syndrome PPS A Randomized Two-Arm Parallel Double-Blind Multi-Centre Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective was to assess the effect of Xepol compared to placebo on physical health and on muscle strength in subjects with post-polio syndromeThe secondary objective was to assess the effect of Xepol compared to placebo on functional balance activity patterns pain fatigue sleep vitality muscular strength pulmonary capacity walking ability balance and safety
Detailed Description:
Study Rationale
In an earlier open and non-controlled study in 10 patients with PPS Xepol was given during three days The patients showed improvements in muscular strength and co-ordination and a decrease in pain The aim of this study was to investigate if these findings can be confirmed in a larger double-blind randomised and placebo controlled study
There are no simple clinical findings and specific laboratory changes that can be used to indicate the severity and progress of PPS Different self-reporting questionnaires and objective measures of disability have often been used in clinical studies including SF-36 questionnaire muscle strength measurement and walking test The primary and secondary variables in this study were based on the clinical experience and literature reviewed
In an earlier open and non-controlled study in 10 patients with PPS Xepol was given during three days The patients showed improvements in muscular strength and co-ordination and a decrease in pain The aim of this study was to investigate if these findings can be confirmed in a larger double-blind randomised and placebo controlled study
There are no simple clinical findings and specific laboratory changes that can be used to indicate the severity and progress of PPS Different self-reporting questionnaires and objective measures of disability have often been used in clinical studies including SF-36 questionnaire muscle strength measurement and walking test The primary and secondary variables in this study were based on the clinical experience and literature reviewed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None