Poliomyelitis SequelaeNCT03396783
Characterization of the Immunological Profile Patients With Post-polio Syndrome
A study testing blood test and electromyogram and walk test in people with Poliomyelitis Sequelae, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis Sequelae
- What is being tested?
- blood test and electromyogram and walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2017to 22 Feb 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Post-polio Syndrome :
- age ≥ 18 years
- meeting the definition of the SPP according to the criteria of Halstead et al. (1995)
- Controlled subjects :
- age ≥ 18 years
- matched on sex and age (+/- 5 years) with subjects with PPS
Who cannot join
- intercurrent neurological pathology,
- uncontrolled cardiovascular risk factors
- pulmonary comorbidity
- endocrine disorders
- systemic inflammatory pathology, autoimmune disease, dry syndrome,
- renal failure
- anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature,
- patients with SPP who received polyvalent IV immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects
Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.
- Conditions
- Poliomyelitis Sequelae
- Being tested
- blood test, electromyogram and walk test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testBiological
during the visit, nurse will make a blood test for biological and immunological analysis
electromyogram and walk testOther
during the visit, measuring the amount of functional motor units at the muscular level and the distance traveled during a 2 minute walk
| Study group | Role | What they receive |
|---|---|---|
| SPP | Experimental | during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test Receives: Biological: blood test; Other: electromyogram and walk test |
| Control | Other | during the visit, nurse will make a blood test for biological and immunological analysis Receives: Biological: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokines blood concentrations
Measured: blood sample during inclusion visit
lymphocytes blood concentrations
Measured: blood sample during inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start6 Dec 2017
- Primary completion22 Feb 2020
- Study completion22 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poliomyelitis SequelaeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LAFFONT, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396783
- Sponsor's protocol ID
- RECHMPL16_0080
- Other IDs
- UF9753
- Status last verified
- Jan 2020
- First submitted
- 9 Nov 2017
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects
- ClinicalTrials.gov ID
- NCT03396783
- Acronym / sponsor ID
- RECHMPL16_0080
- Conditions
- Poliomyelitis Sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 22 Feb 2020 (actual)
- Study completion
- 22 Feb 2020 (actual)
- First posted
- 11 Jan 2018 (actual)
- 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.
Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPP | Experimental | Biological: blood test, Other: electromyogram and walk testduring the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test |
| Control | Other | Biological: blood testduring the visit, nurse will make a blood test for biological and immunological analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- meeting the definition of the SPP according to the criteria of Halstead et al. (1995)
- age ≥ 18 years
- matched on sex and age (+/- 5 years) with subjects with PPS
Key exclusion criteria (8 listed)
- intercurrent neurological pathology,
- uncontrolled cardiovascular risk factors
- pulmonary comorbidity
- endocrine disorders
- systemic inflammatory pathology, autoimmune disease, dry 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 |
|---|---|---|
| blood testduring the visit, nurse will make a blood test for biological and immunological analysis | Biological | Control, SPP |
| electromyogram and walk testduring the visit, measuring the amount of functional motor units at the muscular level and the distance traveled during a 2 minute walk | Other | SPP |
Primary outcome
cytokines blood concentrations
Time frame: blood sample during inclusion visit
lymphocytes blood concentrations
Time frame: blood sample during inclusion visit
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 14 Dec 2022.
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.
Isabelle LAFFONT principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test and electromyogram and walk test in people with Poliomyelitis Sequelae, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 8 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 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
cytokines blood concentrations (time frame: blood sample during inclusion visit). The study lists 2 primary outcomes in all. 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 14 Dec 2022.