Fampridine Pregnancy Exposure Registry

NCT01532154 | Terminated

• 1 other identifier: 218MS402
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Pregnancy

Outcome Measures

Primary Outcomes (9)

• Spontaneous abortions

  < 22 weeks of gestation

• Elective or therapeutic terminations

  Up to 9 months of pregnancy

• Ectopic pregnancy

  Up to 9 months of pregnancy

• Fetal death including still births

  >22 weeks of gestation or weighing 500 grams

• Live born infants

  During delivery time ( at expected average 9 months of pregnancy)

• Premature births

  Delivered before 37 Weeks of gestation

• Maternal death

  During pregnancy, labor or delivery

• Neonatal death

  Prior to 28 days of life

• Birth Defects

  Delivery time (expected 9 months of pregnancy)

Interventions

Fampridine DRUG

As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy

Also known as: dalfampridine, Ampyra, BIIB041, fampridine prolonged-release tablets, Fampyra

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Hopital Pitie Salpetriere

Paris, 75013, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: February 14, 2012
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

FR (1)