Fampridine Pregnancy Exposure Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 31 October 2016
• Main ID: NCT01532154
• Date of registration: 15/12/2011
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Fampridine Pregnancy Exposure Registry
• Scientific title: Fampridine Pregnancy Exposure Registry
• Date of first enrolment: August 2015
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01532154
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France, Germany, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Pregnancy

Intervention(s)

Drug: Fampridine

Primary Outcome(s)

Birth Defects [Time Frame: Delivery time (expected 9 months of pregnancy)]

Elective or therapeutic terminations [Time Frame: Up to 9 months of pregnancy]

Premature births [Time Frame: Delivered before 37 Weeks of gestation]

Spontaneous abortions [Time Frame: < 22 weeks of gestation]

Fetal death including still births [Time Frame: >22 weeks of gestation or weighing 500 grams]

Maternal death [Time Frame: During pregnancy, labor or delivery]

Ectopic pregnancy [Time Frame: Up to 9 months of pregnancy]

Live born infants [Time Frame: During delivery time ( at expected average 9 months of pregnancy)]

Neonatal death [Time Frame: Prior to 28 days of life]

Secondary ID(s)

218MS402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors