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

December 15, 2011
June 28, 2012
Not Provided
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01532154 on ClinicalTrials.gov Archive Site
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Fampridine Pregnancy Exposure Registry
Fampridine Pregnancy Exposure Registry

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

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.

  • Multiple Sclerosis
  • Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
375
January 2017
December 2016   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Medical Director neurologyclinicaltrials@biogenidec.com
Germany
 
NCT01532154
218MS402
No
Biogen Idec Ltd, Medical Director
Biogen Idec
Not Provided
Not Provided
Biogen Idec
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP