Multiple SclerosisNCT01532154
Fampridine Pregnancy Exposure Registry
An observational study of Multiple Sclerosis and Pregnancy, run by Biogen at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Sclerosis, Pregnancy
- What is being tested?
- Fampridine
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to Feb 2016
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Multiple Sclerosis, Pregnancy
- Being tested
- Fampridine
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FampridineDrug
Also called dalfampridine, Ampyra, BIIB041, fampridine prolonged-release tablets
As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous abortions
Measured: < 22 weeks of gestation
Elective or therapeutic terminations
Measured: Up to 9 months of pregnancy
Ectopic pregnancy
Measured: Up to 9 months of pregnancy
Fetal death including still births
Measured: >22 weeks of gestation or weighing 500 grams
Live born infants
Measured: During delivery time ( at expected average 9 months of pregnancy)
Premature births
Measured: Delivered before 37 Weeks of gestation
Maternal death
Measured: During pregnancy, labor or delivery
Neonatal death
Measured: Prior to 28 days of life
Birth Defects
Measured: Delivery time (expected 9 months of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Due to low enrollment, registration closed in agreement with the Regulatory Agency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532154
- Sponsor's protocol ID
- 218MS402
- Status last verified
- Oct 2016
- First submitted
- 15 Dec 2011
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fampridine Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT01532154
- Acronym / sponsor ID
- 218MS402
- Conditions
- Multiple Sclerosis, Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to low enrollment, registration closed in agreement with the Regulatory Agency
- Enrolment
- 1 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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 (2 listed)
- None
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FampridineAlso: dalfampridine, Ampyra, BIIB041, fampridine prolonged-release tabletsAs prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy | Drug | – |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: Due to low enrollment, registration closed in agreement with the Regulatory Agency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Pregnancy, run by Biogen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to low enrollment, registration closed in agreement with the Regulatory Agency). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous abortions (time frame: < 22 weeks of gestation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.