Fampridine Pregnancy Exposure Registry

• Sponsor: Biogen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01532154
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis; Pregnancy	Drug: Fampridine

Detailed 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).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fampridine Pregnancy Exposure Registry
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Outcome Measures

Primary Outcome Measures

1. Spontaneous abortions [< 22 weeks of gestation]

2. Elective or therapeutic terminations [Up to 9 months of pregnancy]

3. Ectopic pregnancy [Up to 9 months of pregnancy]

4. Fetal death including still births [>22 weeks of gestation or weighing 500 grams]

5. Live born infants [During delivery time ( at expected average 9 months of pregnancy)]

6. Premature births [Delivered before 37 Weeks of gestation]

7. Maternal death [During pregnancy, labor or delivery]

8. Neonatal death [Prior to 28 days of life]

9. Birth Defects [Delivery time (expected 9 months of pregnancy)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Pitie Salpetriere	Paris		France	75013

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01532154
• Other Study ID Numbers: 218MS402
• First Posted: Feb 14, 2012
• Last Update Posted: Oct 18, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Multiple Sclerosis; 4-Aminopyridine

Study Results

No Results Posted as of Oct 18, 2016