Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
NCT ID: NCT00160082
Last Updated: 2007-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2001-01-31
2003-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Xepol
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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).
4. Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability.
5. 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).
6. Stable weight (defined as weight change \<7 kg) during the last five years.
7. Body Mass Index (BMI) £ 29 kg/m2.
8. 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
2. Selective IgA deficiency.
3. Inability to walk with walking aids.
4. Any active malignancy, history of active malignancy or treatment for malignancy during the last three years.
5. Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS.
6. Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded).
7. Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit.
8. Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit.
9. Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy.
10. Hepatitis or HIV disease.
11. Increased liver enzymes (ASAT, ALAT, γGT) above twice the upper normal value.
12. Creatine kinase \>10 mkat/l.
13. 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.
14. 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).
15. Conditions associated with a risk of poor protocol compliance (e.g. known drug or alcohol abuse).
16. Previous participation in the study.
18 Years
75 Years
No
Sponsors
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Calliditas Therapeutics AB
INDUSTRY
Principal Investigators
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Kristian Borg, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden
Locations
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Danderyd Hospital
Danderyd, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Huddinge University Hospital
Stockholm, , Sweden
Uppsala Academic Hospital
Uppsala, , Sweden
Countries
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References
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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.
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.
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.
Related Links
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Pharmalink AB (sponsor)
PhD Disertation, Henrik Gonzalez, The post-polio syndrome: Studies of immunology and immunomodulatory intervention
Other Identifiers
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IvIG 1/00
Identifier Type: -
Identifier Source: org_study_id