MigraineNCT03539393
Fremanezumab Managed Access Program for Pediatric Patients
A study testing Fremanezumab in people with Migraine, run by Teva Branded Pharmaceutical Products R&D LLC.
Trial summary
This is a Managed Access Program (MAP) based on a licensed physician's unsolicited request on a compassionate basis. Specifically, this MAP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Fremanezumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 6 to 17 years
- All sexes
- Child
Who may be able to join
- Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures
- In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.
Who cannot join
- Additional criteria may apply, please contact your physician/investigator for more information.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine
This is a Managed Access Program (MAP) based on a licensed physician's unsolicited request on a compassionate basis. Specifically, this MAP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).
Read the detailed description
Eligibility for managed access of TV-48125 (fremanezumab) is currently only open to patients have successfully completed the TV48125-CNS-30084 study.
- Conditions
- Migraine
- Being tested
- Fremanezumab
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FremanezumabDrug
Also called TEV-48125
For patients who enter this program, the monthly dose of fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the patient's weight every 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539393
- Sponsor's protocol ID
- TV48125-CNS-80005
- Other IDs
- TV48125-MH-80011
- Status last verified
- Jul 2026
- First submitted
- 15 May 2018
- Last updated
- 27 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine
- ClinicalTrials.gov ID
- NCT03539393
- Acronym / sponsor ID
- TV48125-CNS-80005
- Conditions
- Migraine
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- First posted
- 29 May 2018 (actual)
- 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 Managed Access Program (MAP) based on a licensed physician's unsolicited request on a compassionate basis. Specifically, this MAP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).
Detailed description
Eligibility for managed access of TV-48125 (fremanezumab) is currently only open to patients have successfully completed the TV48125-CNS-30084 study.
Study design
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures
- In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.
Key exclusion criteria (1 listed)
- Additional criteria may apply, please contact your physician/investigator for more information.
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 |
|---|---|---|
| FremanezumabAlso: TEV-48125For patients who enter this program, the monthly dose of fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the patient's weight every 3 months. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fremanezumab in people with Migraine, run by Teva Branded Pharmaceutical Products R&D LLC.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teva Medical Expert, MD (1-888-483-8279, USMedInfo@tevapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Jul 2026.