Multiple SclerosisNCT02679885
Teriflunomide Male Transmission Study
An observational study of Multiple Sclerosis, run by Griffin Hospital at 1 site in United States.
Trial summary
It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2018
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants in this study will include approximately twenty heterosexual couples. The male partner will be a subject who has been taking teriflunomide as part of his multiple sclerosis treatment for at least three months and engaging in active sexual relations with his female spouse or partner.
Who may be able to join
- Males with relapsing forms of multiple sclerosis appropriately treated with teriflunomide 14 mg po daily;
- Continuous treatment for three months with good compliance as assessed by the investigator
- Age between 18 and 55
- Penile-vaginal intercourse with a female partner at least twice a month with unimpeded ejaculation.
- Compliance with safety assessments, e.g., regular bloodwork for complete blood count and liver function testing as recommended in the Package Insert
- Able to give informed consent
Show all 12Show fewer
- Females
- Regular sexual intercourse with a male partner who is actively taking teriflunomide
- Age between 18 and 55
- Able to give informed consent
- Negative urine pregnancy test at the time of blood sampling
- Reliable contraception that does not involve barrier methods
Who cannot join
- Use of barrier methods of contraception
- For males, contraindications to the continued use of teriflunomide
- Couples that are actively trying to conceive
- For males, noncompliance with teriflunomide therapy
- Inability or unwilling to give consent or comply with the protocol
- Pregnancy of the female sexual partner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple Sclerosis Treatment Center at Griffin Hospital
Derby, Connecticut, 06418
About this study
Official title: Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners
It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males who are taking the drug to treat their multiple sclerosis.
Read the detailed description
A total of 10 couples were enrolled in the study. Females partners had undetectable or borderline levels of teriflunomide.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of teriflunomide in males and their female partners
single laboratory evaluation
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2018
- Study completionSep 2018
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.
- 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
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph B. Guarnaccia, Griffin Hospital
- Investigators
- Joseph Guarnaccia, MD, Principal investigator, MSTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679885
- Sponsor's protocol ID
- TERI001
- Status last verified
- Dec 2018
- First submitted
- 2 Feb 2016
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners
- ClinicalTrials.gov ID
- NCT02679885
- Acronym / sponsor ID
- TERI001
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 10 Feb 2016 (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.
It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males who are taking the drug to treat their multiple sclerosis.
Detailed description
A total of 10 couples were enrolled in the study. Females partners had undetectable or borderline levels of teriflunomide.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants in this study will include approximately twenty heterosexual couples. The male partner will be a subject who has been taking teriflunomide as part of his multiple sclerosis treatment for at least three months and engaging in active sexual relations with his female spouse or partner.
Key inclusion criteria (12 listed)
- Males with relapsing forms of multiple sclerosis appropriately treated with teriflunomide 14 mg po daily;
- Continuous treatment for three months with good compliance as assessed by the investigator
- Age between 18 and 55
- Penile-vaginal intercourse with a female partner at least twice a month with unimpeded ejaculation.
- Compliance with safety assessments, e.g., regular bloodwork for complete blood count and liver function testing as recommended in the Package Insert
Key exclusion criteria (6 listed)
- Use of barrier methods of contraception
- For males, contraindications to the continued use of teriflunomide
- Couples that are actively trying to conceive
- For males, noncompliance with teriflunomide therapy
- Inability or unwilling to give consent or comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum levels of teriflunomide in males and their female partners
Time frame: Up to one year
single laboratory evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
Related trials for Multiple Sclerosis
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking
Multiple Sclerosis
Recruiting
HOBSCOTCH-MS-Efficacy Trial
Multiple Sclerosis, Cognitive Dysfunction
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
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.
Joseph Guarnaccia, MD principal investigator
MSTC
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, run by Griffin Hospital at 1 site in United States.
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 12 inclusion and 6 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: finished, as of the sponsor's last update on 2 Jan 2019. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum levels of teriflunomide in males and their female partners (time frame: Up to one year). 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 2 Jan 2019.