RNS60 for Ischemic Stroke

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ischemic StrokeRNS60 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether a 48-hour infusion of RNS60 can improve outcomes in patients with large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization.

Eligible Conditions
  • Ischemic Stroke

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 90 days

90 days
Infarct progression/regression
Mean BI
Mean NIHSS score
Mean mRS score
Mortality: proportion of participants alive
Proportion of participants with a worsening of stroke
Proportion of subjects with serious adverse events
Quality of life score
Reduction in mortality rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

RNS60
69%Fall
38%Headache
31%Nasopharyngitis
25%Contusion
25%Upper respiratory tract infection
19%Fatigue
19%Constipation
19%Skin abrasion
13%Infusion site extravasation
13%Injection site bruising
13%Infusion site pain
13%Pain in extremity
13%Diarrhoea
13%Cough
13%Dizziness
13%Myalgia
6%Infusion site bruising
6%Infusion site discomfort
6%Feeling Abnormal
6%Vomiting
6%Alanine aminotransferase increased
6%Stoma site pain
6%Tremor
6%Oropharyngeal pain
6%Implant site pain
6%Chest Pain
6%Eye Irritation
6%Abdominal Discomfort
6%Nausea
6%Haemorrhoids
6%Oedema peripheral
6%Cellulitis
6%Feeling hot
6%Injection site extrvasation
6%Conjunctival Haemorrhage
6%Asthenia
6%Joint injury
6%Vertigo
6%Vision Blurred
6%Back pain
6%Head injury
6%Joint swelling
6%Animal bite
6%Sinusitis
6%Seasonal allergy
6%Hypoaesthesia
6%Decreased appetite
6%Muscle haemorrhage
6%Musculoskeletal stiffness
6%Insomnia
6%Feeling Cold
6%Respiratory Failure
6%Flatulence
6%Toothache
6%Defaecation Urgency
6%Chromaturia
6%Skin laceration
6%Muscle spasms
6%Aspartate aminotransferase increased
6%Neck pain
6%Mood altered
6%Pain in jaw
6%Tension headache
6%Alopecia
6%Skin lesion excision
6%Pain
6%Laceration
6%Pulmonary congestion
6%Balance disorder
6%Skin irritation
6%Musculoskeletal chest pain
6%Overdose
6%Muscular weakness
6%Urine odour abnormal
6%Nasal congestion
6%Dyspnoea
6%Respiratory failure
6%Post-traumatic pain
6%Arthralgia
6%Basal cell carcinoma
6%Choking
6%Rash
6%Night sweats
6%Ligament sprain
This histogram enumerates side effects from a completed 2017 Phase 1 trial (NCT02525471) in the RNS60 ARM group. Side effects include: Fall with 69%, Headache with 38%, Nasopharyngitis with 31%, Contusion with 25%, Upper respiratory tract infection with 25%.

Trial Design

3 Treatment Groups

RNS60 1 mL/kg/h
1 of 3
RNS60 0.5 mL/kg/h
1 of 3
Placebo 1 mL/kg/h
1 of 3

Experimental Treatment

Non-Treatment Group

100 Total Participants · 3 Treatment Groups

Primary Treatment: RNS60 · Has Placebo Group · Phase 2

RNS60 1 mL/kg/h
Drug
Experimental Group · 1 Intervention: RNS60 · Intervention Types: Drug
RNS60 0.5 mL/kg/h
Drug
Experimental Group · 1 Intervention: RNS60 · Intervention Types: Drug
Placebo 1 mL/kg/h
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RNS60
2011
Completed Phase 2
~370

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days

Who is running the clinical trial?

Revalesio CorporationLead Sponsor
12 Previous Clinical Trials
361 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA.
Imaging of the chest or abdomen is performed less than 2 hours prior to randomization.
You have provided your informed consent to participate in the study.
AIS selected for emergency endovascular treatment.
Onset time within 24 hours.
You must be between the ages of 18 and 65 years.