Acute Limb IschemiaPhase 2NCT02093468
Evaluation of MST-188 in Acute Lower Limb Ischemia
A Phase 2 study testing MST-188 and Saline in people with Acute Limb Ischemia, run by Mast Therapeutics, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acute Limb Ischemia
- What is being tested?
- MST-188 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2014to Dec 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥30 to <80
- Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb
- Subject is hospitalized or in the process of hospitalization for the treatment of ALI
- Angiographic confirmation of thrombotic lower limb arterial occlusion
Who cannot join
- Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
- Treatment with a thrombolytic agent within the last 48 hours
- Subject's laboratory results indicate inadequate organ function
- NYHA Class IV congestive heart failure
- Prior major amputation of the target limb
- Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Center
Brooklyn, New York, 11219
Research Center
Cleveland, Ohio, 44106
Research Center
Little Rock, Arkansas, 72205
Research Center
Tampa, Florida, 33606
About this study
Official title: Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator
The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.
- Conditions
- Acute Limb Ischemia
- Being tested
- MST-188, Saline
- Keywords
- Acute limb ischemia, ALI, Acute lower extremity arterial occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MST-188Drug
Also called vepoloxamer
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Saline administered IV for 12 hours Receives: Drug: Saline |
| Lower Dose | Experimental | MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours Receives: Drug: MST-188 |
| Higher Dose | Experimental | MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours Receives: Drug: MST-188 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
Measured: Baseline, 8 and 24 hours
Assessment of the change in TcPO2 (Exploratory endpoint)
Measured: Baseline, 8, 12, and 24 hours
Number of participants with adverse events
Measured: Randomization through 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
Why it stopped: Program discontinued to persue alternate indications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Limb IschemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin L Parsley, D.O., Study director, Mast Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093468
- Sponsor's protocol ID
- MST-188-07
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2014
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator
- ClinicalTrials.gov ID
- NCT02093468
- Acronym / sponsor ID
- MST-188-07
- Conditions
- Acute Limb Ischemia
- Keywords
- Acute limb ischemia, ALI, Acute lower extremity arterial occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program discontinued to persue alternate indications.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 21 Mar 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 efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: SalineSaline administered IV for 12 hours |
| Lower Dose | Experimental | Drug: MST-188MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours |
| Higher Dose | Experimental | Drug: MST-188MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥30 to <80
- Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb
- Subject is hospitalized or in the process of hospitalization for the treatment of ALI
- Angiographic confirmation of thrombotic lower limb arterial occlusion
Key exclusion criteria (6 listed)
- Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
- Treatment with a thrombolytic agent within the last 48 hours
- Subject's laboratory results indicate inadequate organ function
- NYHA Class IV congestive heart failure
- Prior major amputation of the target limb
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 |
|---|---|---|
| MST-188Also: vepoloxamer | Drug | Higher Dose, Lower Dose |
| Saline | Drug | Saline |
Primary outcome
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
Time frame: Baseline, 8 and 24 hours
Assessment of the change in TcPO2 (Exploratory endpoint)
Time frame: Baseline, 8, 12, and 24 hours
Number of participants with adverse events
Time frame: Randomization through 30 days post-treatment
Results and safety
The study was stopped early (reason given: Program discontinued to persue alternate indications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
Edwin L Parsley, D.O. study director
Mast Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MST-188 and Saline in people with Acute Limb Ischemia, run by Mast Therapeutics, Inc. at 4 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 6 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 15 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 4 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. 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: Program discontinued to persue alternate indications.). 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?
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint) (time frame: Baseline, 8 and 24 hours). The study lists 3 primary outcomes in all. 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 15 Dec 2015.