Acute Ischaemic Stroke
Conditions
Brief summary
This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Detailed description
Only a small proportion of patients are currently suitable for treatment with clot busting drugs after a stroke. Being able to visualise potentially rescuable brain tissue on scanning may allow more people to be treated. Currently available methods require extra time to acquire and are not therefore widely used. By carrying significant extra oxygen to the brain, the ABL-101 molecule may not only allow the visualisation of salvageable tissue, but also prevent progression of stroke damage in and have an additional direct benefit on tissue survival. Studies in animal models of stroke show smaller areas of stroke damage after ABL-101. There is therefore a rationale for testing this molecule in stroke patients, both as a diagnostic method, and also as a potential therapeutic agent.
Interventions
DRUGABL-101
ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration.
OTHER0.9% NaCl
Placebo
Sponsors
University of Glasgow
Aurum Biosciences Ltd
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years. * Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure. * Ischaemic stroke \<72h after onset. * Previous functional independence (estimated mRS \<3). * Capacity to consent.
Exclusion criteria
* Women of child bearing potential. * Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media). * Known allergy to ABL-101 or any of its constituents, (including egg phospholipids). * Clinical need for, or contraindication to, supplemental oxygen. * Known impaired renal function (eGFR \<30ml/min) precluding radiological contrast. * Known thrombocytopaenia (platelet count \<150x109) or history of platelet function disorder. * Known intercurrent infection. * Known severe COPD or cardiac failure (eg significantly limiting exercise capacity or requiring hospitalisation within the preceding 12 months). * Known significant liver disease (eg liver failure or cirrhosis, chronic infectious or autoimmune hepatitis, or transaminases \>3 times upper limit of normal). * Any current medical condition causing impaired immunity (eg HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days. * Any medical condition potentially limiting survival within the study follow-up period. * Participation in another CTIMP within preceding 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients. | 7 days±2 | Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events throughout the entire study period. | 30 days±5 | — |
| Incidence of adverse events of special interest | 30 days±5 | — |
| Mortality | 30 days | — |
| Modified Rankin Scale (mRS) distribution at day 30. | At day 30 | The mRS is a hierarchical ordinal scale used to assess disability in stroke trials, with seven discrete levels that range from No Symptoms (mRS=0) to death (mRS=6). The Rankin Focused Assessment tool will be used to derive day 30 mRS. |
| Follow-up infarct volume on MRI brain at visit 4. | 48hrs (40-72hrs) | — |
| Incidence of adverse reactions, adverse events, serious adverse events and serious adverse reactions, up to visit 7 (30±5 days) post administration of Investigational medicinal product. | 30 days±5 | — |
Contacts
Primary ContactMaureen Travers
Backup ContactAlicia Murray
Outcome results
None listed