Fampridine Pregnancy Exposure Registry

This study has been terminated.
(Due to low enrollment, registration closed in agreement with the Regulatory Agency)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01532154
First received: December 15, 2011
Last updated: November 30, 2015
Last verified: October 2015

December 15, 2011
November 30, 2015
August 2015
December 2015   (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: Up to 9 months of pregnancy ] [ Designated as safety issue: Yes ]
  • Ectopic pregnancy [ Time Frame: Up to 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: During pregnancy, labor or delivery ] [ Designated as safety issue: Yes ]
  • Neonatal death [ Time Frame: Prior to 28 days of life ] [ Designated as safety issue: Yes ]
  • Birth Defects [ Time Frame: Delivery time (expected 9 months of pregnancy) ] [ Designated as safety issue: Yes ]
  • 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: At delivery time ] [ 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 ]
Complete list of historical versions of study NCT01532154 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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.
There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Weeks
Not Provided
Non-Probability Sample
The study population will be pregnant female participants with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of the last menstrual period or at any time during pregnancy. This information will be from ongoing fampridine clinical studies or the post-marketing setting. The outcome of the pregnancy must not be known at the time of report.
  • Multiple Sclerosis
  • Pregnancy
Drug: Fampridine
As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy
Other Names:
  • dalfampridine
  • Ampyra
  • BIIB041
  • fampridine prolonged-release tablets
  • Fampyra
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
375
December 2015
December 2015   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (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.

Key Exclusion Criteria:

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France
Germany,   United Kingdom,   United States
 
NCT01532154
218MS402
No
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
October 2015

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