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Sponsored by: |
Pharmalink AB |
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Information provided by: | Pharmalink AB |
ClinicalTrials.gov Identifier: | NCT00160082 |
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 syndrome.The 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.
Condition | Intervention |
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Post Polio Syndrome, PPS |
Drug: Xepol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 124 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | May 2003 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Post-polio syndrome according to Halstead and Gawne:
Exclusion Criteria:
Sweden | |
Huddinge University Hospital | |
Stockholm, Sweden, SE-141 86 | |
Danderyd Hospital | |
Danderyd, Sweden | |
Uppsala Academic Hospital | |
Uppsala, Sweden | |
Sahlgrenska University Hospital | |
Gothenburg, Sweden |
Principal Investigator: | Kristian Borg, MD, Prof | Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden |
Study ID Numbers: | IvIG 1/00 |
Study First Received: | September 9, 2005 |
Last Updated: | April 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00160082 |
Health Authority: | Sweden: Medical Products Agency |
Post Polio Syndrome PPS Poliomyelitis Paralylic Polio Late effects of polio |
Late onset polio sequele Xepol IvIg Intravenous Immunoglobuline |
Postpoliomyelitis Syndrome Spinal Cord Diseases Picornaviridae Infections Central Nervous System Diseases Degenerative motor system disease Post Polio syndrome Neurodegenerative Diseases Motor neuron disease Virus Diseases Antibodies Muscular Diseases |
Musculoskeletal Diseases Central Nervous System Infections Neuromuscular Diseases Muscular Disorders, Atrophic Poliomyelitis Myelitis Atrophy Enterovirus Infections Motor Neuron Disease Immunoglobulins |
RNA Virus Infections Pathologic Processes Disease Immunologic Factors Syndrome |
Physiological Effects of Drugs Nervous System Diseases Central Nervous System Viral Diseases Pharmacologic Actions |