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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00404352

NCT00404352
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You had your first episode of possible MS symptoms within the last 60 days, lasting at least 24 hours, involving neurological changes (not just tingling sensations, bladder/bowel issues, or thinking problems)
  • A brain MRI scan shows at least two inactive (symptom-free) lesions that are 3mm or larger, with at least one being oval-shaped, near the centre of the brain, or in the lower part of the brain
  • Your disability score (a standard MS scale) falls between 0 and 5.0 at some point during the screening period
  • You are between 18 and 50 years old (inclusive)
  • You are willing and able to follow all study procedures
  • You have signed a written consent form agreeing to take part
  • If you are female, you must not be pregnant, breastfeeding, or trying to conceive, and must be using a highly reliable form of contraception (such as implants, injections, combined contraceptive pill, certain coils, abstinence, or a vasectomised partner)

Who may not be able to join:

  • You have already been formally diagnosed with MS (using 2005 McDonald criteria)
  • Another condition could better explain your symptoms
  • You have had complete paralysis across the spinal cord or vision loss in both eyes at the same time
  • You have previously used or are currently using any approved MS medication
  • You have taken part in another research study or used an experimental treatment within the last 12 weeks
  • You have used steroid tablets or injections (including ACTH) within the last 30 days
  • Your liver function blood tests are significantly above the normal range (confirm with trial site)
  • Your blood counts are too low, including white blood cells, platelets, or haemoglobin (confirm with trial site)
  • You currently have an autoimmune condition
  • You have a serious physical or mental health condition, including a current or past history of severe depression or thoughts of suicide
  • You have a history of seizures that are not well controlled by treatment
  • You have a heart condition such as angina, heart failure, or irregular heartbeat
  • You have a known allergy to interferon-beta or any ingredients in the study medication
  • You have any condition that would prevent you from having an MRI scan
  • You have a known allergy to the contrast dye used in MRI scans (gadolinium-DTPA)
  • You have previously taken part in this same trial
  • You have taken part in any clinical trial within the past 6 months
  • You have ever used any immune-modifying or immune-suppressing treatments, including a wide range of specific medications such as interferon, glatiramer acetate, natalizumab, or others (confirm full list with trial site)
  • You have used any experimental MS treatments before joining, including statins taken specifically to prevent MS
  • You have a history of alcohol or drug misuse
  • You are unable to tolerate both paracetamol (acetaminophen) and ibuprofen
  • You are unable to give yourself (or have a carer give you) injections under the skin
  • You have moderate to severe kidney problems

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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Merck KGaA, Darmstadt, Germany
Registry
clinicaltrials_gov
Start date
1 November 2006
Est. completion
1 August 2010

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇧 Lebanon Morocco 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇸🇦 Saudi Arabia 🇷🇸 Serbia 🇸🇰 Slovakia 🇪🇸 Spain Turkey (Türkiye)

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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

View original record on ClinicalTrials.gov