Congenital Myasthenic SyndromePOCoMSNCT01474980
Pregnancy Outcomes in Congenital Myasthenie Syndrome
An observational study of Congenital Myasthenic Syndrome, run by Institut de Myologie, France.
Trial summary
This is a retrospective study that follows the clinical evolution, the pregnancy and the post-partum perioad of female patients with Congenital Myasthenic Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Myasthenic Syndrome
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Oct 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Congenital Myasthenie Syndrome
Who may be able to join
- Adult women
- Congenital myastenic syndrome genetically confirmed or with clinical compatible and electrophysiological evidence
- Written consent
Who cannot join
- Neurological or general pathology occurs significantly with the initiation and conduct of a pregnancy.
About this study
Official title: Retrospective Study :Describe the Changes of the Disease in Many Cases Likely to Aggravate.
This is a retrospective study that follows the clinical evolution, the pregnancy and the post-partum perioad of female patients with Congenital Myasthenic Syndrome.
Read the detailed description
The aim of this study is to better understand the action of hormonal factors that are presumably incriminated for the fluctuation of the disease. The investigators would also like to better adress the issues of women with Congenital Myasthenic Syndrome, who desire a pregnancy : the possibility of decompensation, the problems that can arise during the course of the childbearing, the risk of foetal malformations.
- Conditions
- Congenital Myasthenic Syndrome
- Keywords
- Congenital Myasthenic Syndrome, Pregnancy, Outcome
- Medical subject headings
- Myasthenic Syndromes, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Myasthenic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Laurent Servais, M.D., Institut de Myologie, France
- Investigators
- Laurent SERVAIS, MD, PhD, Principal investigator, institut myologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474980
- Sponsor's protocol ID
- 2010-A00495-34
- Acronym
- POCoMS
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2011
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study :Describe the Changes of the Disease in Many Cases Likely to Aggravate.
- ClinicalTrials.gov ID
- NCT01474980
- Acronym / sponsor ID
- POCoMS / 2010-A00495-34
- Conditions
- Congenital Myasthenic Syndrome
- Keywords
- Congenital Myasthenic Syndrome, Pregnancy, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Nov 2011 (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.
This is a retrospective study that follows the clinical evolution, the pregnancy and the post-partum perioad of female patients with Congenital Myasthenic Syndrome.
Detailed description
The aim of this study is to better understand the action of hormonal factors that are presumably incriminated for the fluctuation of the disease. The investigators would also like to better adress the issues of women with Congenital Myasthenic Syndrome, who desire a pregnancy : the possibility of decompensation, the problems that can arise during the course of the childbearing, the risk of foetal malformations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Congenital Myasthenie Syndrome
Key inclusion criteria (3 listed)
- Adult women
- Congenital myastenic syndrome genetically confirmed or with clinical compatible and electrophysiological evidence
- Written consent
Key exclusion criteria (1 listed)
- Neurological or general pathology occurs significantly with the initiation and conduct of a pregnancy.
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
Not reported in the source record.
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 18 Nov 2011.
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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.
Laurent SERVAIS, MD, PhD principal investigator
institut myologie
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Myasthenic Syndrome, run by Institut de Myologie, 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 18 Nov 2011. 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. 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.
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 18 Nov 2011.