Fampridine Pregnancy Exposure Registry

Multiple Sclerosis Clinical Trial

Official title:

Fampridine Pregnancy Exposure Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01532154
• Other study ID #: 218MS402
• Status: Terminated
• Phase: N/A
• First received: December 15, 2011
• Last updated: October 17, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéSpain: Agencia Española de Medicamentos y Productos SanitariosFrance: French Data Protection AuthorityGermany: Ethics CommissionEuropean Union: European Medicines Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
France	Hopital Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous abortions		< 22 weeks of gestation	Yes
Primary	Elective or therapeutic terminations		Up to 9 months of pregnancy	Yes
Primary	Ectopic pregnancy		Up to 9 months of pregnancy	Yes
Primary	Fetal death including still births		>22 weeks of gestation or weighing 500 grams	Yes
Primary	Live born infants		During delivery time ( at expected average 9 months of pregnancy)	Yes
Primary	Premature births		Delivered before 37 Weeks of gestation	Yes
Primary	Maternal death		During pregnancy, labor or delivery	Yes
Primary	Neonatal death		Prior to 28 days of life	Yes
Primary	Birth Defects		Delivery time (expected 9 months of pregnancy)	Yes