- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474980
Pregnancy Outcomes in Congenital Myasthenie Syndrome (POCoMS)
November 17, 2011 updated by: Laurent Servais, M.D., Institut de Myologie, France
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
25
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with Congenital Myasthenie Syndrome
Description
Inclusion criteria:
- Adult women
- Congenital myastenic syndrome genetically confirmed or with clinical compatible and electrophysiological evidence
- Written consent
Exclusion Criteria:
- Neurological or general pathology occurs significantly with the initiation and conduct of a pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurent SERVAIS, MD, PhD, institut myologie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
November 16, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 18, 2011
Study Record Updates
Last Update Posted (Estimate)
November 18, 2011
Last Update Submitted That Met QC Criteria
November 17, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Disease
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
- Syndrome
- Lambert-Eaton Myasthenic Syndrome
- Myasthenic Syndromes, Congenital
Other Study ID Numbers
- 2010-A00495-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Institut de Myologie, FranceAssociation Française contre les Myopathies (AFM), ParisCompletedMyasthenia Gravis | Lambert-Eaton Myasthenic Syndrome | Congenital Myasthenic Syndrome | Autoimmune Myasthenia GravisFrance
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