Post-Poliomyélitis SyndromPPS and IGIVNCT04004390
Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin
An observational study of Post-Poliomyélitis Syndrom, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Post-Poliomyélitis Syndrom
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2019to 30 Dec 2019
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 men and 11 women with Diagnosis of PPS
Who may be able to join
- Diagnosis of PPS
- Pre- and post-therapeutic evaluation carried out
- Data transcribed in the computerized patient file
Who cannot join
- No walking patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin: a Retrospective Study of Efficacy on Clinical and Isokinetic Criteria
Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital
Read the detailed description
Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation.
Collection of data retrospectively.
- Conditions
- Post-Poliomyélitis Syndrom
- Keywords
- Pre- and post-therapeutic evaluation carried out, Data transcribed in the computerized patient file, post-poliomyelitis syndrome, Intravenous immunoglobulins, walking test, isokinetics
- Medical subject headings
- Postpoliomyelitis Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Muscular strength with isokinetic
Measured: 5 months
Secondary outcomes (1)
Walking perimeter
Walking perimeter with walking test (6 minutes)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start28 Jun 2019
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Poliomyélitis SyndromStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOIZIARD Vincent, intern, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004390
- Sponsor's protocol ID
- RECHMPL19_0322
- Acronym
- PPS and IGIV
- Status last verified
- Mar 2020
- First submitted
- 28 Jun 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin: a Retrospective Study of Efficacy on Clinical and Isokinetic Criteria
- ClinicalTrials.gov ID
- NCT04004390
- Acronym / sponsor ID
- PPS and IGIV / RECHMPL19_0322
- Conditions
- Post-Poliomyélitis Syndrom
- Keywords
- Pre- and post-therapeutic evaluation carried out, Data transcribed in the computerized patient file, post-poliomyelitis syndrome, Intravenous immunoglobulins, walking test, isokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 2 Jul 2019 (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.
Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital
Detailed description
Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation.
Collection of data retrospectively.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 men and 11 women with Diagnosis of PPS
Key inclusion criteria (3 listed)
- Diagnosis of PPS
- Pre- and post-therapeutic evaluation carried out
- Data transcribed in the computerized patient file
Key exclusion criteria (1 listed)
- No walking patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscular strength
Time frame: 5 months
Muscular strength with isokinetic
1 secondary outcome
Walking perimeter
Time frame: 5 months
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 10 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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.
MOIZIARD Vincent, intern principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Poliomyélitis Syndrom, 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 3 inclusion and 1 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 10 Mar 2020. 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?
Muscular strength (time frame: 5 months). 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 10 Mar 2020.