Multiple SclerosisPhase 1NCT01318421
A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 1 study testing ELND002 in people with Multiple Sclerosis, run by Elan Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ELND002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.
Who cannot join
- Subject has no new medical contraindications to continue participation in the study.
About this study
Official title: An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.
- Conditions
- Multiple Sclerosis
- Being tested
- ELND002
- Keywords
- Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELND002Drug
| Study group | Role | What they receive |
|---|---|---|
| ELND002 | Experimental | ELND002 sc injection Receives: Drug: ELND002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
Safety and tolerability will be assessed by frequency and severity of AEs.
Measured: 1 year
Secondary outcomes (1)
To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318421
- Sponsor's protocol ID
- ELND002-MS153
- Status last verified
- Dec 2015
- First submitted
- 8 Mar 2011
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01318421
- Acronym / sponsor ID
- ELND002-MS153
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Elan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- First posted
- 18 Mar 2011 (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.
The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELND002 | Experimental | Drug: ELND002ELND002 sc injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.
Key exclusion criteria (1 listed)
- Subject has no new medical contraindications to continue participation in the study.
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 |
|---|---|---|
| ELND002 | Drug | ELND002 |
Primary outcome
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
Time frame: 1 year
Safety and tolerability will be assessed by frequency and severity of AEs.
1 secondary outcome
To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELND002 in people with Multiple Sclerosis, run by Elan Pharmaceuticals.
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 1 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: stopped early, as of the sponsor's last update on 14 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT). (time frame: 1 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 14 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.