Multiple SclerosisPhase 1NCT01144351
A Safety and Efficacy 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 at 20 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS). 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?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Mar 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
- Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
- Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
- Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
- Is able and willing to undergo Gd administration and repeat MRI testing
Who cannot join
- Has primary progressive MS (PPMS)
- Any history of treatment with recombinant humanized monoclonal antibodies
- Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
- A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
- Any history of congestive heart failure or currently has a pacemaker
- Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug
- Has any medical history or psychiatric condition that would impact outcome or study participation
- Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States17 sites
Research Site
Albuquerque, New Mexico, 87106
Research Site
Aurora, Colorado, 80045
Research Site
Berkeley, California, 94705
Research Site
Cincinnati, Ohio, 45219
Research Site
Cordova, Tennessee, 78258
Research Site
Farmington Hills, Michigan, 48334
Research Site
Fresno, California, 93710
Research Site
Knoxville, Tennessee, 37920
Research Site
Minneapolis, Minnesota, 55404
Research Site
Newport Beach, California, 92663
Research Site
Northbrook, Illinois, 60062
Research Site
Raleigh, North Carolina, 27607
Research Site
Salt Lake City, Utah, 84106
Research Site
San Antonio, Texas, 78258
Research Site
Tampa, Florida, 33609
Research Site
Uniontown, Ohio, 44685
Research Site
Vero Beach, Florida, 32960
Canada3 sites
Research Site
Calgary, Alberta, T2N 2T9
Research Site
Greenfield Park, Quebec, J4V 2J2
Research Site
Montreal, Quebec, H3A 2B4
About this study
Official title: A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).
- Conditions
- Multiple Sclerosis
- Being tested
- ELND002, Placebo
- Keywords
- MS, SPMS, RRMS, Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS), or Relapsing-Remitting Multiple Sclerosis (RRMS)
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELND002Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ELND002 | Experimental | ELND002 sc injection Receives: Drug: ELND002 |
| Placebo | Placebo comparator | placebo injection Receives: Drug: Placebo |
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) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).
Measured: 12 weeks
Secondary outcomes (3)
Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Measured: 12 weeks
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
Measured: 12 weeks
Reduction in rate of clinical relapses.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startMar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT01144351
- Sponsor's protocol ID
- ELND002-MS103
- Status last verified
- Dec 2015
- First submitted
- 9 Jun 2010
- Last updated
- 14 Dec 2015
- Results posted
- 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
- A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01144351
- Acronym / sponsor ID
- ELND002-MS103
- Conditions
- Multiple Sclerosis
- Keywords
- MS, SPMS, RRMS, Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS), or Relapsing-Remitting Multiple Sclerosis (RRMS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Elan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- First posted
- 15 Jun 2010 (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 determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELND002 | Experimental | Drug: ELND002ELND002 sc injection |
| Placebo | Placebo comparator | Drug: Placeboplacebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
- Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
- Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
- Is able and willing to undergo Gd administration and repeat MRI testing
Key exclusion criteria (8 listed)
- Has primary progressive MS (PPMS)
- Any history of treatment with recombinant humanized monoclonal antibodies
- Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
- A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
- Any history of congestive heart failure or currently has a pacemaker
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 |
| Placebo | Drug | Placebo |
Primary outcome
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).
Time frame: 12 weeks
3 secondary outcomes
Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)
Time frame: 12 weeks
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
Time frame: 12 weeks
Reduction in rate of clinical relapses.
Time frame: 12 weeks
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.
20 sites in 2 countries: see every site and its status.
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 at 20 sites in 2 countries.
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 4 inclusion and 8 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.
Where is the study taking place?
The record lists 20 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS). (time frame: 12 weeks). 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.