Fampridine Pregnancy Exposure Registry
What it found
The trial ended early for another reason (see below).
Reason given: Due to low enrollment, registration closed in agreement with the Regulatory Agency
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
What it measured
Main measures
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)
Who could take part
MS (type not specified)
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: * None NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Aug 2015
Main results due
Feb 2016
Finished
Feb 2016
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