Fampridine Pregnancy Exposure Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01532154
First received: December 15, 2011
Last updated: July 23, 2015
Last verified: July 2015
  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 ] [ Designated as safety issue: Yes ]
  • Elective or therapeutic terminations [ Time Frame: Up to 9 months of pregnancy ] [ Designated as safety issue: Yes ]
  • Ectopic pregnancy [ Time Frame: Up to 9 months of pregnancy ] [ Designated as safety issue: Yes ]
  • Fetal death including still births [ Time Frame: >22 weeks of gestation or weighing 500 grams ] [ Designated as safety issue: Yes ]
  • Live born infants [ Time Frame: During delivery time ( at expected average 9 months of pregnancy) ] [ Designated as safety issue: Yes ]
  • Premature births [ Time Frame: Delivered before 37 Weeks of gestation ] [ Designated as safety issue: Yes ]
  • Maternal death [ Time Frame: During pregnancy, labor or delivery ] [ Designated as safety issue: Yes ]
  • Neonatal death [ Time Frame: Prior to 28 days of life ] [ Designated as safety issue: Yes ]
  • Birth Defects [ Time Frame: Delivery time (expected 9 months of pregnancy) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 375
Study Start Date: December 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (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

Genders 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:

  • None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532154

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
United States, Massachusetts
Biogen Fampridine Exposure Registry Recruiting
Cambirdge, Massachusetts, United States, 02142
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01532154     History of Changes
Other Study ID Numbers: 218MS402
Study First Received: December 15, 2011
Last Updated: July 23, 2015
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: French Data Protection Authority
Germany: Ethics Commission
European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on August 03, 2015