Phase 4 Multiple Sclerosis Trial, Terminated NCT02342704 Sponsor: Biogen Condition: Multiple Sclerosis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02342704) enrolled 108 people with multiple sclerosis — 54 in a group receiving natalizumab and 54 in a group receiving fingolimod. The trial was designed to compare these two treatments by looking at changes in brain lesions over time, measured using MRI scans. Very few participants completed the full study: only 1 person in the natalizumab group and 3 in the fingolimod group were recorded as completing it, with the large majority not completing the trial for reasons not detailed in the submitted data. The reported data shows that for the primary outcome — tracking a specific type of long-lasting brain lesion (called T1-hypointense lesions) that developed from active lesions seen on MRI scans — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the secondary outcomes, the reported data shows that the average cumulative number of new active brain lesions visible on MRI (called T1-Gd+ lesions, meaning lesions that "light up" with a special dye) was reported as 0.62 for the natalizumab group compared with 1.69 for the fingolimod group at one time point, with similar patterns at later time points. The average number of new or enlarging lesions on a different type of MRI scan (T2 lesions) was reported as 1.33 for natalizumab and 1.94 for fingolimod. Changes in total lesion volume from the start of the study were also reported across both scan types and time points, with figures varying between the two groups. The proportion of participants showing "no evidence of disease activity" — a combined measure of no relapses, no worsening disability, and no new lesions — was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Multiple Sclerosis Trial, Terminated

NCT02342704
Terminated Phase 4 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

For people with Multiple Sclerosis (MS):

  • You must have a confirmed diagnosis of relapsing MS, with a disability score between 0.0 and 5.5 on a standard MS scale.
  • If you are currently taking one of these MS medications (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, or Aubagio), you must have been on it for at least 6 months, have at least 9 lesions visible on a brain MRI, and have had at least 1 relapse in the last 6 months along with new lesions shown on a recent brain MRI (confirm with trial site).
  • If you have a very active form of MS (whether or not you have taken any MS medication before), you must have had at least 2 severe relapses in the past 12 months and have new lesions visible on a recent brain MRI (confirm with trial site).

For healthy volunteers:

  • You must be in generally good health, with no history of serious illnesses, confirmed by a physical exam and medical history.
  • If you are able to become pregnant, you must be willing and able to use effective birth control for the entire duration of the study.
  • You must not have had any drug or alcohol misuse problems in the past year.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

For people with Multiple Sclerosis (MS):

  • You have been diagnosed with Primary Progressive MS or Secondary Progressive MS.
  • You have HIV, hepatitis C, or an active hepatitis B infection, or test positive for these at screening.
  • You have previously been treated with the MS medications natalizumab or fingolimod.
  • You have a current or past history of cancer, including blood cancers or solid tumours (except certain completely removed and cured skin cancers).
  • You have a history of serious opportunistic infections or other significant major illnesses, as judged by the study doctor.
  • You have had a significant infectious illness (such as pneumonia or blood poisoning) within the past month.
  • You have had problems with drug or alcohol misuse in the past year.
  • You have used certain immune-suppressing medications or received certain biological treatments within the past 12 months (confirm with trial site for the full list).
  • You have had a heart attack, unstable chest pain, stroke, mini-stroke, or severe heart failure in the past 6 months.
  • You are currently taking certain heart rhythm medications known as Class Ia or Class III anti-arrhythmic drugs (confirm with trial site for specific drug names).
  • You are currently taking medications that slow your heart rate, such as certain blood pressure or heart medications (confirm with trial site for specific drug names).
  • You have high blood pressure that is not controlled by your current medications.
  • You have a history of severe lung disease, lung scarring, or severe chronic obstructive pulmonary disease (COPD).
  • You have received a live vaccine within the 8 weeks before screening.

For healthy volunteers:

  • You experience claustrophobia (fear of enclosed spaces) severe enough to prevent you from having a reliable MRI scan.
  • You have a history of major illness, including neurological conditions, as determined by the study doctor.
  • You have a metal implant or device in your body that is affected by MRI, such as a pacemaker, aneurysm clip, or implanted defibrillator, or any metal fragments in your body.
  • You are currently pregnant, breastfeeding, or have a positive pregnancy test at screening.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Trial contact details on record

Principal Investigator: Medical Director, Biogen

Australian sites

Research Site, Camperdown, New South Wales
Research Site, New Lambton Heights, New South Wales
Research Site, Heidelberg, Victoria

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 4
Sponsor
Registry
ClinicalTrials.gov
Start date
30 November 2014
Est. completion
18 May 2016

Where this trial was run

🇦🇺 Australia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov