Multiple SclerosisPhase 1NCT01424423
NOGO-A in Multiple Sclerosis FTIH
A Phase 1 study testing GSK1223249 in people with Multiple Sclerosis, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth. The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- GSK1223249
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Feb 2010to 26 Aug 2010
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Suitable as determined by the Principal Investigator, based on his/her overall evaluation. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Diagnosed with a relapsing form of MS defined as either
- Relapsing Remitting MS according to revised McDonald Criteria [McDonald, 2001; Polman, 2005] plus any one of the following:
- Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
- OR
- -Secondary Progressive MS, plus any one of the following: Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
- Expanded Disability Status Scale (EDSS) score ≤5.5
- Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Who cannot join
- Abnormal baseline blood tests
- Treatment with interferon-beta-1b (Betaferon), interferon-beta-1a (Rebif or Avonex), or glatiramer acetate (Copaxone) within 90 days of dosing.
- Treatment with methylprednisolone or any other systemic steroids within 60 days of dosing.
- Treatment within the past 12 months or currently with any of the following agents: cyclosporine, azathioprine, methotrexate, cladribine, natalizumab (Tysabri®) or other monoclonal antibodies, murine protein, T-cell vaccination, plasmapheresis, IVI gG, ,stem cell transplantation.
- History of intolerance to acetominophen, ibuprofen, naproxen or any other non-steroidal anti-inflammatory agent which would preclude use of at least one of these during the study.
- Previous history of anaphylaxis, severe allergic reaction, or hypersensitivity to albumin or a protein-based therapeutic, including natalizumab (Tysabri) or any other monoclonal antibody. History of hypersensitivity to any of the components of the formulation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
- Patients with evidence of dementia or psychiatric illness which, in the Investigator's opinion, is likely to prevent them from a full understanding of and/or compliance with the study requirements and procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy
The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth.
The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).
Read the detailed description
This is a phase I study of GSK1223249. The study design is randomized, placebo-controlled, double-blind, sequential dose escalation, single dose administration. Approximately 36 patients with relapsing forms of Multiple Sclerosis (having had at least two relapses over the previous 24 months, OR at least one relapse within the last 12 months, OR having had at least one documented gadolinium-enhancing lesion on brain magnetic resonance imaging (MRI) within 12 months prior to Screening) will be enrolled.
- Conditions
- Multiple Sclerosis
- Being tested
- Placebo, GSK1223249
- Keywords
- Safety, GSK1223249, Pharmacokinetics, Single dose escalation, anti-GSK1223249 antibodies, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
GSK1223249Drug
I.V. Infusion
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving GSK1223249 in cohort 1 | Experimental | Eligible subjects will receive intravenous infusion of GSK1223249 with a starting dose of 0.02 milligrams per kilograms, followed by 0.2, 2, 10 and 30 milligrams per kilograms, administered by a programmable syringe pump. Receives: Drug: GSK1223249 |
| Subjects receiving placebo in cohort 1 | Placebo comparator | Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. Receives: Drug: Placebo |
| Subjects receiving GSK1223249 in cohort 2 | Experimental | Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 0.2 milligrams per kilograms administered by a programmable syringe pump. Receives: Drug: GSK1223249 |
| Subjects receiving placebo in cohort 2 | Placebo comparator | Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. Receives: Drug: Placebo |
| Subjects receiving GSK1223249 in cohort 3 | Experimental | Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 2 milligrams per kilograms administered by a programmable syringe pump. Receives: Drug: GSK1223249 |
| Subjects receiving placebo in cohort 3 | Placebo comparator | Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. Receives: Drug: Placebo |
| Subjects receiving GSK1223249 in cohort 4 | Experimental | Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 10 milligrams per kilograms administered by a programmable syringe pump. Receives: Drug: GSK1223249 |
| Subjects receiving placebo in cohort 4 | Placebo comparator | Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. Receives: Drug: Placebo |
| Subjects receiving GSK1223249 in cohort 5 | Experimental | Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 30 milligrams per kilograms administered by a programmable syringe pump. Receives: Drug: GSK1223249 |
| Subjects receiving placebo in cohort 5 | Placebo comparator | Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The preliminary safety and tolerability of single doses of GSK1223249
changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses
Measured: screening, baseline (pre-dose) and up to 84 days post dose
Secondary outcomes (1)
Single dose pharmacokinetics.
(AUC(0-∞)
Measured: screening, baseline (pre-dose) and up to 84 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study start11 Feb 2010
- Primary completion26 Aug 2010
- Study completion26 Aug 2010
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424423
- Sponsor's protocol ID
- 112988
- Status last verified
- Sep 2017
- First submitted
- 9 Jun 2011
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy
- ClinicalTrials.gov ID
- NCT01424423
- Acronym / sponsor ID
- 112988
- Conditions
- Multiple Sclerosis
- Keywords
- Safety, GSK1223249, Pharmacokinetics, Single dose escalation, anti-GSK1223249 antibodies, Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2010 (actual)
- Primary completion
- 26 Aug 2010 (actual)
- Study completion
- 26 Aug 2010 (actual)
- First posted
- 29 Aug 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 drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth.
The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).
Detailed description
This is a phase I study of GSK1223249. The study design is randomized, placebo-controlled, double-blind, sequential dose escalation, single dose administration. Approximately 36 patients with relapsing forms of Multiple Sclerosis (having had at least two relapses over the previous 24 months, OR at least one relapse within the last 12 months, OR having had at least one documented gadolinium-enhancing lesion on brain magnetic resonance imaging (MRI) within 12 months prior to Screening) will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving GSK1223249 in cohort 1 | Experimental | Drug: GSK1223249Eligible subjects will receive intravenous infusion of GSK1223249 with a starting dose of 0.02 milligrams per kilograms, followed by 0.2, 2, 10 and 30 milligrams per kilograms, administered by a programmable syringe pump. |
| Subjects receiving placebo in cohort 1 | Placebo comparator | Drug: PlaceboEligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. |
| Subjects receiving GSK1223249 in cohort 2 | Experimental | Drug: GSK1223249Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 0.2 milligrams per kilograms administered by a programmable syringe pump. |
| Subjects receiving placebo in cohort 2 | Placebo comparator | Drug: PlaceboEligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. |
| Subjects receiving GSK1223249 in cohort 3 | Experimental | Drug: GSK1223249Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 2 milligrams per kilograms administered by a programmable syringe pump. |
| Subjects receiving placebo in cohort 3 | Placebo comparator | Drug: PlaceboEligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. |
| Subjects receiving GSK1223249 in cohort 4 | Experimental | Drug: GSK1223249Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 10 milligrams per kilograms administered by a programmable syringe pump. |
| Subjects receiving placebo in cohort 4 | Placebo comparator | Drug: PlaceboEligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. |
| Subjects receiving GSK1223249 in cohort 5 | Experimental | Drug: GSK1223249Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 30 milligrams per kilograms administered by a programmable syringe pump. |
| Subjects receiving placebo in cohort 5 | Placebo comparator | Drug: PlaceboEligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Suitable as determined by the Principal Investigator, based on his/her overall evaluation. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Diagnosed with a relapsing form of MS defined as either
- Relapsing Remitting MS according to revised McDonald Criteria [McDonald, 2001; Polman, 2005] plus any one of the following:
- Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
- OR
Key exclusion criteria (8 listed)
- Abnormal baseline blood tests
- Treatment with interferon-beta-1b (Betaferon), interferon-beta-1a (Rebif or Avonex), or glatiramer acetate (Copaxone) within 90 days of dosing.
- Treatment with methylprednisolone or any other systemic steroids within 60 days of dosing.
- Treatment within the past 12 months or currently with any of the following agents: cyclosporine, azathioprine, methotrexate, cladribine, natalizumab (Tysabri®) or other monoclonal antibodies, murine protein, T-cell vaccination, plasmapheresis, IVI gG, ,stem cell transplantation.
- History of intolerance to acetominophen, ibuprofen, naproxen or any other non-steroidal anti-inflammatory agent which would preclude use of at least one of these during 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 |
|---|---|---|
| PlaceboPlacebo | Drug | Subjects receiving placebo in cohort 1, Subjects receiving placebo in cohort 2, Subjects receiving placebo in cohort 3, Subjects receiving placebo in cohort 4, Subjects receiving placebo in cohort 5 |
| GSK1223249I.V. Infusion | Drug | Subjects receiving GSK1223249 in cohort 1, Subjects receiving GSK1223249 in cohort 2, Subjects receiving GSK1223249 in cohort 3, Subjects receiving GSK1223249 in cohort 4, Subjects receiving GSK1223249 in cohort 5 |
Primary outcome
The preliminary safety and tolerability of single doses of GSK1223249
Time frame: screening, baseline (pre-dose) and up to 84 days post dose
changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses
1 secondary outcome
Single dose pharmacokinetics.
Time frame: screening, baseline (pre-dose) and up to 84 days post dose
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 20 Sep 2017.
- Results for study 112988 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1223249 in people with Multiple Sclerosis, run by GlaxoSmithKline at 1 site in Australia.
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 8 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 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The preliminary safety and tolerability of single doses of GSK1223249 (time frame: screening, baseline (pre-dose) and up to 84 days post dose). 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 20 Sep 2017.