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Fampridine Pregnancy Exposure Registry

This study has been terminated.
(Due to low enrollment, registration closed in agreement with the Regulatory Agency)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532154
First Posted: February 14, 2012
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
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 Intervention
Multiple Sclerosis Pregnancy Drug: Fampridine

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Fampridine Pregnancy Exposure Registry

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Spontaneous abortions [ Time Frame: < 22 weeks of gestation ]
  • Elective or therapeutic terminations [ Time Frame: Up to 9 months of pregnancy ]
  • Ectopic pregnancy [ Time Frame: Up to 9 months of pregnancy ]
  • Fetal death including still births [ Time Frame: >22 weeks of gestation or weighing 500 grams ]
  • Live born infants [ Time Frame: During delivery time ( at expected average 9 months of pregnancy) ]
  • Premature births [ Time Frame: Delivered before 37 Weeks of gestation ]
  • Maternal death [ Time Frame: During pregnancy, labor or delivery ]
  • Neonatal death [ Time Frame: Prior to 28 days of life ]
  • Birth Defects [ Time Frame: Delivery time (expected 9 months of pregnancy) ]

Enrollment: 1
Study Start Date: August 2015
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fampridine
    As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy
    Other Names:
    • dalfampridine
    • Ampyra
    • BIIB041
    • fampridine prolonged-release tablets
    • Fampyra
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532154


Locations
France
Hopital Pitie Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01532154     History of Changes
Other Study ID Numbers: 218MS402
First Submitted: December 15, 2011
First Posted: February 14, 2012
Last Update Posted: October 18, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action


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