search
Back to results

Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)

Primary Purpose

Post Polio Syndrome, PPS

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Xepol
Sponsored by
Calliditas Therapeutics AB
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Polio Syndrome, PPS focused on measuring Post Polio Syndrome, PPS, Poliomyelitis, Paralylic Polio, Late effects of polio, Late onset polio sequele, Xepol, IvIg, Intravenous Immunoglobuline

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria: Male or female subjects ≥18 to ≤75 years of age. Post-polio syndrome according to Halstead and Gawne: History of polio virus infection Restitution or improvement regarding motor function and disabilities after initial infection Confirmed polio by EMG Subjectively increased muscular weakness after a period of at least 15 years functional stability No other explanation but post-polio syndrome to the symptoms Confirmed polio by EMG in the lower extremities in at least two of the following major muscle groups; musculi quadriceps, gastrocnemicus and tibialis anterior. (Two affected muscle groups in the same extremity were accepted). Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability. A muscle that had deteriorated within the last five years, and had 20-75 % of the muscle strength compared to age matched normal population when measured by a dynamometer or an electronic grip force sensor (GRIPPIT). Stable weight (defined as weight change <7 kg) during the last five years. Body Mass Index (BMI) £ 29 kg/m2. Subjects capable to understand given information and had signed the Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits. Exclusion Criteria: Known or suspected intolerance to trial product or related products (e.g. sorbitol, glucose and fructose). Selective IgA deficiency. Inability to walk with walking aids. Any active malignancy, history of active malignancy or treatment for malignancy during the last three years. Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS. Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded). Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit. Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit. Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy. Hepatitis or HIV disease. Increased liver enzymes (ASAT, ALAT, γGT) above twice the upper normal value. Creatine kinase >10 mkat/l. Any disease or treatment that according to the discretion of the Investigator could pose a medical threat to the subject in combination with study drug, i.e. clinical manifested severe cardiovascular disease or severe arteriosclerosis or severe psychiatric disorder or other treatment that affected the immunological system such as prednisone and methotrexate. Any disease or condition that according to the discretion of the Investigator would obstruct the subject from performing the tests in the protocol (e.g. fill in the questionnaires). Conditions associated with a risk of poor protocol compliance (e.g. known drug or alcohol abuse). Previous participation in the study.

Sites / Locations

  • Danderyd Hospital
  • Sahlgrenska University Hospital
  • Huddinge University Hospital
  • Uppsala Academic Hospital

Outcomes

Primary Outcome Measures

Primary endpoints:
Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure.
Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen.

Secondary Outcome Measures

Secondary endpoints:
Functional balance was assessed by using the Timed "Up and Go" (TUG) test.
Activity pattern was assessed by the Physical Activity Scale of the Elderly (PASE).
Pain was assessed by a Visual Analogue Scale and by a pain drawing.
Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
Vitality was assessed using the vitality subscale (VT) of SF-36 questionnaire.
Sleep was assessed using the Sleep quality scale.
Muscular strength measured by a dynamometer and an electronic grip force sensor (GRIPPIT) for those muscles not included as the primary endpoint.
Walking ability was assessed by a 6 minutes walking test.
Pulmonary capacity (vital capacity, FEV1, FEV %) was measured by a standard spirometer method.
Balance was assessed as postural sway velocity and the subject's ability to voluntarily sway to various locations in space (NeuroCom Balance Master) or balance assessed by static and dynamic posturography (Chattecx® balance system)
Adverse events
Vital signs (blood pressure and heart rate)
Physical examination
Laboratory tests

Full Information

First Posted
September 9, 2005
Last Updated
April 2, 2007
Sponsor
Calliditas Therapeutics AB
search

1. Study Identification

Unique Protocol Identification Number
NCT00160082
Brief Title
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Calliditas Therapeutics AB

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Polio Syndrome, PPS
Keywords
Post Polio Syndrome, PPS, Poliomyelitis, Paralylic Polio, Late effects of polio, Late onset polio sequele, Xepol, IvIg, Intravenous Immunoglobuline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
124 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Xepol
Primary Outcome Measure Information:
Title
Primary endpoints:
Title
Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure.
Title
Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen.
Secondary Outcome Measure Information:
Title
Secondary endpoints:
Title
Functional balance was assessed by using the Timed "Up and Go" (TUG) test.
Title
Activity pattern was assessed by the Physical Activity Scale of the Elderly (PASE).
Title
Pain was assessed by a Visual Analogue Scale and by a pain drawing.
Title
Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
Title
Vitality was assessed using the vitality subscale (VT) of SF-36 questionnaire.
Title
Sleep was assessed using the Sleep quality scale.
Title
Muscular strength measured by a dynamometer and an electronic grip force sensor (GRIPPIT) for those muscles not included as the primary endpoint.
Title
Walking ability was assessed by a 6 minutes walking test.
Title
Pulmonary capacity (vital capacity, FEV1, FEV %) was measured by a standard spirometer method.
Title
Balance was assessed as postural sway velocity and the subject's ability to voluntarily sway to various locations in space (NeuroCom Balance Master) or balance assessed by static and dynamic posturography (Chattecx® balance system)
Title
Adverse events
Title
Vital signs (blood pressure and heart rate)
Title
Physical examination
Title
Laboratory tests

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects ≥18 to ≤75 years of age. Post-polio syndrome according to Halstead and Gawne: History of polio virus infection Restitution or improvement regarding motor function and disabilities after initial infection Confirmed polio by EMG Subjectively increased muscular weakness after a period of at least 15 years functional stability No other explanation but post-polio syndrome to the symptoms Confirmed polio by EMG in the lower extremities in at least two of the following major muscle groups; musculi quadriceps, gastrocnemicus and tibialis anterior. (Two affected muscle groups in the same extremity were accepted). Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability. A muscle that had deteriorated within the last five years, and had 20-75 % of the muscle strength compared to age matched normal population when measured by a dynamometer or an electronic grip force sensor (GRIPPIT). Stable weight (defined as weight change <7 kg) during the last five years. Body Mass Index (BMI) £ 29 kg/m2. Subjects capable to understand given information and had signed the Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits. Exclusion Criteria: Known or suspected intolerance to trial product or related products (e.g. sorbitol, glucose and fructose). Selective IgA deficiency. Inability to walk with walking aids. Any active malignancy, history of active malignancy or treatment for malignancy during the last three years. Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS. Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded). Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit. Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit. Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy. Hepatitis or HIV disease. Increased liver enzymes (ASAT, ALAT, γGT) above twice the upper normal value. Creatine kinase >10 mkat/l. Any disease or treatment that according to the discretion of the Investigator could pose a medical threat to the subject in combination with study drug, i.e. clinical manifested severe cardiovascular disease or severe arteriosclerosis or severe psychiatric disorder or other treatment that affected the immunological system such as prednisone and methotrexate. Any disease or condition that according to the discretion of the Investigator would obstruct the subject from performing the tests in the protocol (e.g. fill in the questionnaires). Conditions associated with a risk of poor protocol compliance (e.g. known drug or alcohol abuse). Previous participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Borg, MD, Prof
Organizational Affiliation
Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Danderyd
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Huddinge University Hospital
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Uppsala Academic Hospital
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
12409177
Citation
Gonzalez H, Khademi M, Andersson M, Wallstrom E, Borg K, Olsson T. Prior poliomyelitis-evidence of cytokine production in the central nervous system. J Neurol Sci. 2002 Dec 15;205(1):9-13. doi: 10.1016/s0022-510x(02)00316-7.
Results Reference
background
PubMed Identifier
15081258
Citation
Gonzalez H, Khademi M, Andersson M, Piehl F, Wallstrom E, Borg K, Olsson T. Prior poliomyelitis-IVIg treatment reduces proinflammatory cytokine production. J Neuroimmunol. 2004 May;150(1-2):139-44. doi: 10.1016/j.jneuroim.2004.01.010.
Results Reference
background
PubMed Identifier
16713921
Citation
Gonzalez H, Sunnerhagen KS, Sjoberg I, Kaponides G, Olsson T, Borg K. Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial. Lancet Neurol. 2006 Jun;5(6):493-500. doi: 10.1016/S1474-4422(06)70447-1.
Results Reference
result
Links:
URL
http://www.pharmalink.se
Description
Pharmalink AB (sponsor)
URL
http://diss.kib.ki.se/2005/91-7140-483-X/
Description
PhD Disertation, Henrik Gonzalez, The post-polio syndrome: Studies of immunology and immunomodulatory intervention

Learn more about this trial

Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)

We'll reach out to this number within 24 hrs