Post Polio Syndrome, PPSNCT00160082
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
A study testing Xepol in people with Post Polio Syndrome, PPS, run by Calliditas Therapeutics AB at 4 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Polio Syndrome, PPS
- What is being tested?
- Xepol
- How many people
- 124 participants
- Where
- 4 sitesSweden
- Study dates
- Jan 2001to May 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Danderyd Hospital
Danderyd
Sahlgrenska University Hospital
Gothenburg
Huddinge University Hospital
Stockholm, SE-141 86
Uppsala Academic Hospital
Uppsala
About this 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
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.
Read the 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.
- Conditions
- Post Polio Syndrome, PPS
- Being tested
- Xepol
- Keywords
- Post Polio Syndrome, PPS, Poliomyelitis, Paralylic Polio, Late effects of polio, Late onset polio sequele, Xepol, IvIg, Intravenous Immunoglobuline
- Medical subject headings
- Postpoliomyelitis Syndrome, Popliteal Pterygium Syndrome, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XepolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (15)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2001
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Polio Syndrome, PPSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 124 participants
Sponsor and investigators
- Lead sponsor
- Calliditas Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kristian Borg, MD, Prof, Principal investigator, Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160082
- Sponsor's protocol ID
- IvIG 1/00
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 3 Apr 2007
- Results posted
- No
Publications
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.
PubMed 12409177Gonzalez 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.
PubMed 15081258Gonzalez 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.
PubMed 16713921
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00160082
- Acronym / sponsor ID
- IvIG 1/00
- Conditions
- Post Polio Syndrome, PPS
- Keywords
- Post Polio Syndrome, PPS, Poliomyelitis, Paralylic Polio, Late effects of polio, Late onset polio sequele, Xepol, IvIg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants
- Lead sponsor
- Calliditas Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- May 2003
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects ≥18 to ≤75 years of age.
- Post-polio syndrome according to Halstead and Gawne:
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xepol | Drug | – |
Primary outcome
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.
15 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2007.
- Background: PubMed 12409177Gonzalez 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.
- Background: PubMed 15081258Gonzalez 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 publication: PubMed 16713921Gonzalez 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.
- Pharmalink AB (sponsor)Link provided by the sponsor.
- PhD Disertation, Henrik Gonzalez, The post-polio syndrome: Studies of immunology and immunomodulatory interventionLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Borg, MD, Prof principal investigator
Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xepol in people with Post Polio Syndrome, PPS, run by Calliditas Therapeutics AB at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints:. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00160082, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2007.