Multiple SclerosisPhase 1NCT00616733
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
A Phase 1 study testing CS-0777 tablets in people with Multiple Sclerosis, run by Daiichi Sankyo at 5 sites in United States.
Trial summary
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis. 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?
- CS-0777 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2008to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)
- Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months
- Baseline EDSS score of 0 - 6.5
- Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
Who cannot join
- Primary progressive MS
- Any medical condition that predisposes to immunocompromise
- History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
- Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
- Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
- Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
- Treatment with interferon beta or glatiramer acetate within 2 months of study initiation
- Prior treatment with natalizumab or rituximab
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Billings, Montana
Study site
Denver, Colorado
Study site
Lenexa, Kansas
Study site
Philadelphia, Pennsylvania
Study site
Port Orange, Florida
About this study
Official title: An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- CS-0777 tablets
- Keywords
- Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-0777 tabletsDrug
0.1 mg, once-weekly, for 12 weeks
CS-0777 tabletsDrug
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
CS-0777 tabletsDrug
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CS-0777 tablets |
| 2 | Experimental | Not described Receives: Drug: CS-0777 tablets |
| 3 | Experimental | Not described Receives: Drug: CS-0777 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability.
Measured: 12 weeks, with 4 weeks to follow-up
Secondary outcomes (1)
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
Measured: 12 weeks, with 4 weeks to follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2010
- Study completionSep 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 Daiichi SankyoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616733
- Sponsor's protocol ID
- CS0777-A-U102
- Other IDs
- IND 77,409
- Status last verified
- Mar 2011
- First submitted
- 4 Feb 2008
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00616733
- Acronym / sponsor ID
- CS0777-A-U102
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Feb 2008 (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.
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CS-0777 tablets |
| 2 | Experimental | Drug: CS-0777 tablets |
| 3 | Experimental | Drug: CS-0777 tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)
- Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months
- Baseline EDSS score of 0 - 6.5
- Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
Key exclusion criteria (8 listed)
- Primary progressive MS
- Any medical condition that predisposes to immunocompromise
- History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
- Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
- Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
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 |
|---|---|---|
| CS-0777 tablets0.1 mg, once-weekly, for 12 weeks | Drug | 1 |
| CS-0777 tablets0.3 mg, once-weekly or once every 2 weeks, for 12 weeks | Drug | 2 |
| CS-0777 tablets0.6 mg, once-weekly or once every 2 weeks, for 12 weeks | Drug | 3 |
Primary outcome
Safety and tolerability.
Time frame: 12 weeks, with 4 weeks to follow-up
1 secondary outcome
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
Time frame: 12 weeks, with 4 weeks to follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS-0777 tablets in people with Multiple Sclerosis, run by Daiichi Sankyo at 5 sites in United States.
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: finished, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability. (time frame: 12 weeks, with 4 weeks to follow-up). 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 10 Mar 2011.