Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fampridine Pregnancy Exposure Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Biogen Idec
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01532154
First received: December 15, 2011
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.


Condition
Multiple Sclerosis
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fampridine Pregnancy Exposure Registry

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Spontaneous abortions [ Time Frame: < 22 weeks of gestation ] [ Designated as safety issue: Yes ]
  • Elective or therapeutic terminations [ Time Frame: Upto 9 months of pregnancy ] [ Designated as safety issue: Yes ]
  • Ectopic pregnancy [ Time Frame: Upto 9 months of pregnancy ] [ Designated as safety issue: Yes ]
  • Fetal death including still births [ Time Frame: >22 weeks of gestation or weighing 500 grams ] [ Designated as safety issue: Yes ]
  • Live born infants [ Time Frame: During delivery time ( at expected average 9 months of pregnancy) ] [ Designated as safety issue: Yes ]
  • Premature births [ Time Frame: Delivered before 37 Weeks of gestation ] [ Designated as safety issue: Yes ]
  • Maternal death [ Time Frame: Upto 10 months of pregnancy ] [ Designated as safety issue: Yes ]
  • Neonatal death [ Time Frame: Prior to 28 days of life ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 375
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy. Approximately 375 prolonged release fampridine exposed pregnancies wil be enrolled. There are no mandatory physician visits. The registry will collect pregnancy oucome data from the patients health care provider during the the prenatal follow up (6-7 months gestation), pregancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study poulation will be female patients who have been exposed to prolonged release fampridine since the first day of the last menstrual period. This information will be from ongoing fampridine clinical studies and spontaneous medical reports received from health care providers.

Criteria

Inclusion Criteria:

  • Documentation that the patient was exposed to prolonged-release fampridine since the first day of her LMP prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.)
  • The outcome of the pregnancy must not be known at the time of report.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532154

Contacts
Contact: Medical Director neurologyclinicaltrials@biogenidec.com

Locations
Germany
Research Site Recruiting
Bochum, Germany
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Ltd, Medical Director
ClinicalTrials.gov Identifier: NCT01532154     History of Changes
Other Study ID Numbers: 218MS402
Study First Received: December 15, 2011
Last Updated: June 28, 2012
Health Authority: Germany: Ethics Commission
European Union: European Medicines Agency

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014