Post-polio SyndromePhase 3NCT01537575
Intravenous Immunoglobulins for Post-Polio Syndrome
A Phase 3 study testing intravenous immunoglobulins and Saline solution in people with Post-polio Syndrome, run by Azienda Ospedaliera Universitaria Integrata Verona.
Trial summary
Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-polio Syndrome
- What is being tested?
- intravenous immunoglobulins and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of acute poliomyelitis
- increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
- a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi
Who cannot join
- clinically relevant systemic disease
- malignancy
- hypothyroidism
- diabetes mellitus not fully controlled by medical therapy
- medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
- conditions associated with prolonged coagulation time
Show all 10Show fewer
- serum IgA deficiency
- previous allergic reaction to IVIG
- body-mass index greater than 30
- immune-modulating treatments other than IVIG within the preceding 6 months
About this study
Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.
- Conditions
- Post-polio Syndrome
- Being tested
- intravenous immunoglobulins, Saline solution
- Medical subject headings
- Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulinsBiological
One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
Saline solutionBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| saline solution | Placebo comparator | Not described Receives: Biological: Saline solution |
| intravenous immunoglobulins | Experimental | Not described Receives: Biological: intravenous immunoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 physical component
Measured: Baseline; 2 and 4 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJan 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-polio SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537575
- Sponsor's protocol ID
- EUDRACT-200700-3559-35
- Status last verified
- Feb 2012
- First submitted
- 17 Feb 2012
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Immunoglobulins for Post-Polio Syndrome
- ClinicalTrials.gov ID
- NCT01537575
- Acronym / sponsor ID
- EUDRACT-200700-3559-35
- Conditions
- Post-polio Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 23 Feb 2012 (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.
Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline solution | Placebo comparator | Biological: Saline solution |
| intravenous immunoglobulins | Experimental | Biological: intravenous immunoglobulins |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a history of acute poliomyelitis
- increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
- a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi
Key exclusion criteria (10 listed)
- clinically relevant systemic disease
- malignancy
- hypothyroidism
- diabetes mellitus not fully controlled by medical therapy
- medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
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 |
|---|---|---|
| intravenous immunoglobulinsOne course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days | Biological | intravenous immunoglobulins |
| Saline solutionPlacebo | Biological | saline solution |
Primary outcome
SF-36 physical component
Time frame: Baseline; 2 and 4 months after treatment
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 27 Feb 2012.
Related trials for Post-polio Syndrome
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Nomad P-KAFO Study
Cerebrovascular Accident, Post-polio Syndrome
Active, not recruiting
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
Spinal Cord Injuries, Poliomyelitis
RecruitingObservational study
Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
ALS (Amyotrophic Lateral Sclerosis), Postpoliomyelitis Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous immunoglobulins and Saline solution in people with Post-polio Syndrome, run by Azienda Ospedaliera Universitaria Integrata Verona.
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 3 inclusion and 10 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 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
SF-36 physical component (time frame: Baseline; 2 and 4 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2012.