Middle Cerebral Artery StrokePhase 2NCT00401310
The Efficacy and Safety of MK0724 IV for Improvement of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke (0724-018)
A Phase 2 study testing Comparator: MK0724 in people with Middle Cerebral Artery Stroke, run by Merck Sharp & Dohme LLC.
Trial summary
The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a specific functional deficit and subsequent recovery correlating with the specific area of stroke in the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Middle Cerebral Artery Stroke
- What is being tested?
- Comparator: MK0724
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jan 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 yrs of age inclusive
- Patient is able to receive IV infusion 8-36 hours after stroke onset
- Baseline NIHSS of 6-18 inclusive
Who cannot join
- Patient had another stroke within 3 months preceding current stroke, patient's stroke is of origin other than MCA (e.g., non-ischemic, hemorrhage), significant cerebral edema, abnormal liver enzymes and abnormal renal and hepatic functions
About this study
Official title: A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of MK0724 Intravenous Infusion on the Amelioration of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke
The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a specific functional deficit and subsequent recovery correlating with the specific area of stroke in the brain.
- Conditions
- Middle Cerebral Artery Stroke
- Being tested
- Comparator: Placebo, Comparator: MK0724
- Medical subject headings
- Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: PlaceboDrug
Placebo IV infusions 1hr/daily over 7 days.
Comparator: MK0724Drug
MK0724 8 mg/kg/hr 1 hr/daily over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
| 2 | Experimental | MK0724 Receives: Drug: Comparator: MK0724 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test score
Measured: At 90 days
Secondary outcomes (1)
Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.
Measured: At 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Termination date was 20-Oct-2008. Subjects were monitored during the post treatment 90 day follow-up period (per protocol) resulting in LPLV 19-Jan-2009.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Cerebral Artery StrokeStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401310
- Sponsor's protocol ID
- 0724-018
- Other IDs
- 2006_559
- Status last verified
- Jul 2015
- First submitted
- 17 Nov 2006
- Last updated
- 22 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of MK0724 Intravenous Infusion on the Amelioration of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00401310
- Acronym / sponsor ID
- 0724-018
- Conditions
- Middle Cerebral Artery Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination date was 20-Oct-2008. Subjects were monitored during the post treatment 90 day follow-up period (per protocol) resulting in LPLV 19-Jan-2009.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Nov 2006 (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 safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a specific functional deficit and subsequent recovery correlating with the specific area of stroke in the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
| 2 | Experimental | Drug: Comparator: MK0724MK0724 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 yrs of age inclusive
- Patient is able to receive IV infusion 8-36 hours after stroke onset
- Baseline NIHSS of 6-18 inclusive
Key exclusion criteria (1 listed)
- Patient had another stroke within 3 months preceding current stroke, patient's stroke is of origin other than MCA (e.g., non-ischemic, hemorrhage), significant cerebral edema, abnormal liver enzymes and abnormal renal and hepatic functions
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 |
|---|---|---|
| Comparator: PlaceboPlacebo IV infusions 1hr/daily over 7 days. | Drug | 1 |
| Comparator: MK0724MK0724 8 mg/kg/hr 1 hr/daily over 7 days. | Drug | 2 |
Primary outcome
Action Research Arm Test score
Time frame: At 90 days
1 secondary outcome
Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.
Time frame: At 90 days
Results and safety
The study was stopped early (reason given: Termination date was 20-Oct-2008. Subjects were monitored during the post treatment 90 day follow-up period (per protocol) resulting in LPLV 19-Jan-2009.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Related trials for Middle Cerebral Artery Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
RecruitingObservational study
Long-Term Cognitive Recovery After Arteria Cerebri Media Ischemia: A Digital Assessment Using the TuCAN-App
Cognitive Recovery After Stroke, Cognitive Outcome After Stroke
Recruiting
Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT)
Middle Cerebral Artery Acute Ischemic Stroke
Not yet recruiting
Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
Chronic Subdural Hematoma, Stroke
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comparator: MK0724 in people with Middle Cerebral Artery Stroke, run by Merck Sharp & Dohme LLC.
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 3 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 22 Jul 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. 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 stopped early (reason given: Termination date was 20-Oct-2008. Subjects were monitored during the post treatment 90 day follow-up period (per protocol) resulting in LPLV 19-Jan-2009.). 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?
Action Research Arm Test score (time frame: At 90 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 22 Jul 2015.