StrokePhase 2NCT02258880
Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke
A Phase 2 study testing SUN13837 in people with Stroke, run by Daiichi Sankyo at 53 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- SUN13837
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 53 sitesin 4 countries
- Study dates
- Sep 2014to May 2016
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Prior exposure to SUN13837
- History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine
- Development of hemodynamic instability following the acute stroke
- History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results
- Presence of significant global or receptive aphasia
Show all 11Show fewer
- Presence of clinically significant abnormal laboratory values at the time of presentation in the ER
- History of malabsorption or any gastrointestinal abnormality that could impair oral absorption
- Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes mellitus
- Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or potent P glycoprotein (P gp) inhibitors
- Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset
Trial locations and contacts
53 sites in 4 countries.
53 sites in 4 countries
United States37 sites
Study site
Atlanta, Georgia, 30322
Study site
Brooklyn, New York, 11220
Study site
Bryn Mawr, Pennsylvania, 19010
Study site
Chapel Hill, North Carolina, 27599
Study site
Chattanooga, Tennessee, 37404
Study site
Columbia, South Carolina, 29203
Study site
Columbus, Ohio, 43210
Study site
Detroit, Michigan, 48201
Study site
Detroit, Michigan, 48236
Study site
Edison, New Jersey, 08818
Study site
Encinita, California, 92024
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77030
Study site
Kalispell, Montana, 59901
Study site
Lexington, Kentucky, 40536
Study site
Marrero, Louisiana, 70072
Study site
Mechanicsville, Virginia, 23116
Study site
Midlothian, Virginia, 23114
Study site
Mobile, Alabama, 36693
Study site
New Orleans, Louisiana, 70112
Study site
New Orleans, Louisiana, 70121
Study site
Novi, Michigan, 48374
Study site
Oceanside, California, 92056
Study site
Paoli, Pennsylvania, 19301
Study site
Philadelphia, Pennsylvania, 19102
Study site
Portland, Oregon, 97201
Study site
Portland, Oregon, 97213
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Portland, Oregon, 97225
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Reno, Nevada, 89502
Study site
Richmond, Virginia, 23226
Study site
Richmond, Virginia, 23298
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Sarasota, Florida, 34239
Study site
Savannah, Georgia, 31405
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Southfield, Michigan, 48705
Study site
Summit, New Jersey, 07901
Study site
Tampa, Florida, 33606
Study site
Worcester, Massachusetts, 01655
Israel7 sites
Study site
Haifa, 3109601
Study site
Haifa, 3339419
Study site
Holon, 5822012
Study site
Kfar Saba, 4428164
Study site
Naharyia, 2210001
Study site
Ramat Gan, 5262100
Study site
Tel Aviv, 6423906
South Africa6 sites
Study site
Alberton, Gauteng, 1449
Study site
Bellville, Western Cape, 7350
Study site
Bloemfontein, Free State, 9301
Study site
Krugersdorp, Gauteng, 1739
Study site
Somerset West, Western Cape, 7130
Study site
Worcester, Western Cape, 6850
Canada3 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Saint-Jérôme, Quebec, J7Z 5T3
Study site
Victoria, British Columbia, V8R 1J8
About this study
Official title: A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SUN13837 Administered 28 Doses (27/28 Days) to Adult Subjects With an Acute Ischemic Stroke
The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.
- Conditions
- Stroke
- Being tested
- SUN13837, placebo
- Keywords
- Acute Stroke, Outcome Measures, Physical Performance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUN13837Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| SUN13837 | Experimental | Drug: SUN13837 daily for 28 days. Receives: Drug: SUN13837 |
| Placebo | Placebo comparator | Placebo: Matching Placebo daily for 28 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
Measured: 84 days
Secondary outcomes (6)
The proportion of responders as measured by the PPAS
Measured: 84 days
Mean change from baseline in PPAS Patient Reported Outcome Subscale
Measured: 84 days
Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)
Measured: 84 days
Mean change from baseline in Gait Speed
Measured: 84 days
Proportion of responders as measured by the Modified Rankin Scale (mRS)
Measured: 84 days
Safety/Tolerability - Number of Participants with Adverse Events
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: study was stopped for business/administrative reasons and not for patient safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Ger Rikken, MD, Study director, Asubio Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258880
- Sponsor's protocol ID
- ASBI 802
- Status last verified
- Oct 2015
- First submitted
- 29 Sep 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SUN13837 Administered 28 Doses (27/28 Days) to Adult Subjects With an Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02258880
- Acronym / sponsor ID
- ASBI 802
- Conditions
- Stroke
- Keywords
- Acute Stroke, Outcome Measures, Physical Performance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was stopped for business/administrative reasons and not for patient safety concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Sep 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 8 Oct 2014 (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 safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.
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 |
|---|---|---|
| SUN13837 | Experimental | Drug: SUN13837Drug: SUN13837 daily for 28 days. |
| Placebo | Placebo comparator | Drug: placeboPlacebo: Matching Placebo daily for 28 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Prior exposure to SUN13837
- History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine
- Development of hemodynamic instability following the acute stroke
- History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results
- Presence of significant global or receptive aphasia
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 |
|---|---|---|
| SUN13837 | Drug | SUN13837 |
| placebo | Drug | Placebo |
Primary outcome
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
Time frame: 84 days
6 secondary outcomes
The proportion of responders as measured by the PPAS
Time frame: 84 days
Mean change from baseline in PPAS Patient Reported Outcome Subscale
Time frame: 84 days
Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)
Time frame: 84 days
Mean change from baseline in Gait Speed
Time frame: 84 days
Proportion of responders as measured by the Modified Rankin Scale (mRS)
Time frame: 84 days
Safety/Tolerability - Number of Participants with Adverse Events
Time frame: 84 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
Ger Rikken, MD study director
Asubio Pharmaceuticals, Inc.
53 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUN13837 in people with Stroke, run by Daiichi Sankyo at 53 sites in 4 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 0 inclusion and 11 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: withdrawn, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Israel, South Africa, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS) (time frame: 84 days). 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 Oct 2015.