Ischemic StrokePhase 1NCT02963376

A Phase Ib/II in Patients With Acute Ischemic Stroke

A Phase 1 study testing 0.05 mL/kg DDFPe, 0.10 mL/kg DDFPe and 0.17 mL/kg DDFPe in people with Ischemic Stroke, run by NuvOx LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ischemic Stroke
What is being tested?: 0.05 mL/kg DDFPe, 0.10 mL/kg DDFPe and 0.17 mL/kg DDFPe
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2017to 9 Jul 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Ages 18-80 years
Diagnosis of AIS
Body weight ≥ 45 kg
NIHSS between 2 and 20
Patient or legal authorized representative (LAR) must be willing and able to understand the study and provide written informed consent

Who cannot join

Currently pregnant or breastfeeding
History of significantly impaired renal or hepatic function
Hemorrhage or hemorrhagic stroke on CT scan
Prior stroke, intracranial surgery, or major head trauma within three months prior to enrollment
Pre-stroke modified Rankin Scale (mRS) ≥ 2
Myocardial infarction within six (6) months prior to enrollment

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Unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure
Uncontrolled hypertension (SBP > 180 and/or diastolic blood pressure (DBP) > 110 mmHg)
Known long QT syndrome or QTc > 450 milliseconds (ms) in males and > 470 ms in females
Uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six (6) months (except atrial fibrillation)
Clinically significant chronic obstructive pulmonary disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously
Pneumonia, bronchitis, or other acute respiratory disease
Current anticoagulant therapy except for antiplatelet therapy (aspirin, NSAIDs) and prophylactic doses of low molecular weight heparin to prevent deep vein thrombosis. Note: tPA administered as part of subjects' therapy for AIS is allowed.
History of allergic reaction attributed to compounds of similar chemical composition to DDFPe (see Investigator's Brochure).
Subject has received any investigational drug within thirty (30) days prior to enrollment into the study
Inability to comply with the study procedures
History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: A Phase Ib/II Dose-finding Study of DDFPe in Patients With Acute Ischemic Stroke

Stroke is the fifth leading cause of death in the United States and is the leading cause of long term disability. Distinct geographic disparities in stroke mortality, with highest rates in the southeast United States including Arkansas, are known as the "stroke belt." There the average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the leading cause of serious long-term disability. Between 2012 and 2030, disability and medical costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with the majority of the projected increase in costs arising from those 65 to 79 years of age.

There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in 85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond the effective time window for therapy is a common reason for failure.

To reduce the devastating impact of stroke on individuals and society, the investigators continue to seek ways to improve functional recovery and limit ischemic damage in stroke patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has recently shown strong positive effects in pre-clinical animal models of acute ischemic stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants and blood substitutes yet none have been successful.

Conditions: Ischemic Stroke
Being tested: 0.05 mL/kg DDFPe, 0.05 mL/kg Placebo, 0.10 mL/kg DDFPe, 0.10 mL/kg Placebo, 0.17 mL/kg DDFPe
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.05 mL/kg DDFPeDrug
Also called Dodecafluoropentane emulsion (DDFPe), NanO2TM
Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg).
0.05 mL/kg PlaceboDrug
Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg).
0.10 mL/kg DDFPeDrug
Also called Dodecafluoropentane emulsion (DDFPe), NanO2TM
Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg).
0.10 mL/kg PlaceboDrug
Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg).
0.17 mL/kg DDFPeDrug
Also called Dodecafluoropentane emulsion (DDFPe), NanO2TM
Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg).
0.17 mL/kg PlaceboDrug
Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg).

Study groups in NCT02963376
Study group	Role	What they receive
0.05 mL/kg DDFPe	Active comparator	This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. Receives: Drug: 0.05 mL/kg DDFPe
0.05 mL/kg Placebo	Placebo comparator	This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. Receives: Drug: 0.05 mL/kg Placebo
0.10 mL/kg DDFPe	Active comparator	This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. Receives: Drug: 0.10 mL/kg DDFPe
0.10 mL/kg Placebo	Placebo comparator	This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. Receives: Drug: 0.10 mL/kg Placebo
0.17 mL/kg DDFPe	Active comparator	This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. Receives: Drug: 0.17 mL/kg DDFPe
0.17 mL/kg Placebo	Placebo comparator	This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. Receives: Drug: 0.17 mL/kg Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities
The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol. If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop.
Measured: 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)

Secondary outcomes (2)

NIHSS Assessment
The NIH Stroke Scale (NIHSS) is an assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination. Ratings for each item are scored on a 3- to 5-point scale with 0 as normal. Scores range from 0 to 42, with higher scores indicating greater severity.
Measured: NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge.
Modified Rankin Scale (mRS)
The modified Rankin Scale is a measure of the degree of disability in patients who have had a stroke with 0 being no symptoms at all to 6 being death. Thus, a higher score indicates greater severity.
Measured: mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20179 Jul 2018

First posted15 Nov 2016 (estimated)
Study start1 Feb 2017
Primary completion9 Jul 2018
Study completion9 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02963376
Sponsor's protocol ID: 205529
Status last verified: Aug 2021
First submitted: 10 Nov 2016
Last updated: 24 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Culp WC, Onteddu SS, Brown A, Nalleballe K, Sharma R, Skinner RD, Witt T, Roberson PK, Marsh JD. Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial. J Vasc Interv Radiol. 2019 Aug;30(8):1244-1250.e1. doi: 10.1016/j.jvir.2019.04.020.
PubMed 31349978

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
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Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
Recruiting
Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
Stroke, Ischemic Cerebrovascular Accident
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic

All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Dose-finding Study of DDFPe in Patients With Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT02963376
Acronym / sponsor ID: 205529
Conditions: Ischemic Stroke
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: NuvOx LLCIndustry (pharma, biotech, devices)
Collaborators: University of Arkansas
Study start: 1 Feb 2017 (actual)
Primary completion: 9 Jul 2018 (actual)
Study completion: 9 Jul 2018 (actual)
First posted: 15 Nov 2016 (estimated)
Results: Posted 24 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
0.05 mL/kg DDFPe	Active comparator	Drug: 0.05 mL/kg DDFPeThis study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
0.05 mL/kg Placebo	Placebo comparator	Drug: 0.05 mL/kg PlaceboThis study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
0.10 mL/kg DDFPe	Active comparator	Drug: 0.10 mL/kg DDFPeThis study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
0.10 mL/kg Placebo	Placebo comparator	Drug: 0.10 mL/kg PlaceboThis study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
0.17 mL/kg DDFPe	Active comparator	Drug: 0.17 mL/kg DDFPeThis study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
0.17 mL/kg Placebo	Placebo comparator	Drug: 0.17 mL/kg PlaceboThis study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Ages 18-80 years
Diagnosis of AIS
Body weight ≥ 45 kg
NIHSS between 2 and 20
Patient or legal authorized representative (LAR) must be willing and able to understand the study and provide written informed consent

Key exclusion criteria (17 listed)

Currently pregnant or breastfeeding
History of significantly impaired renal or hepatic function
Hemorrhage or hemorrhagic stroke on CT scan
Prior stroke, intracranial surgery, or major head trauma within three months prior to enrollment
Pre-stroke modified Rankin Scale (mRS) ≥ 2

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
0.05 mL/kg DDFPeAlso: Dodecafluoropentane emulsion (DDFPe), NanO2TMPrior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg).	Drug	0.05 mL/kg DDFPe
0.05 mL/kg PlaceboPrior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg).	Drug	0.05 mL/kg Placebo
0.10 mL/kg DDFPeAlso: Dodecafluoropentane emulsion (DDFPe), NanO2TMPrior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg).	Drug	0.10 mL/kg DDFPe
0.10 mL/kg PlaceboPrior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg).	Drug	0.10 mL/kg Placebo
0.17 mL/kg DDFPeAlso: Dodecafluoropentane emulsion (DDFPe), NanO2TMPrior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg).	Drug	0.17 mL/kg DDFPe
0.17 mL/kg PlaceboPrior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg).	Drug	0.17 mL/kg Placebo

Primary outcome

Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities
Time frame: 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)
The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol. If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop.

2 secondary outcomes

NIHSS Assessment
Time frame: NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge.
Modified Rankin Scale (mRS)
Time frame: mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90.

Results and safety

Results posted to the registry on 24 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.05 mL/kg DDFPe	6	6
0.05 mL/kg Placebo	2	2
0.10 mL/kg DDFPe	6	6
0.10 mL/kg Placebo	2	2
0.17 mL/kg DDFPe	6	6
0.17 mL/kg Placebo	2	2

Primary outcome: Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities

Time frame: 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). Number. Unit: Dose Limiting Toxicities

Measure	0.05 mL/kg DDFPe n = 6	0.05 mL/kg Placebo n = 2	0.10 mL/kg DDFPe n = 6	0.10 mL/kg Placebo n = 2	0.17 mL/kg DDFPe n = 6	0.17 mL/kg Placebo n = 2
Value	0	0	0	0	0	0

Population analysed: No signs of dose-limiting episodes were identified at any dose level, and no MTD was defined.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study treatment follow-up was within 90 days following the last administration of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Controls (n=6)	3 of 6 (50%)	6 of 6 (100%)	1 of 6
DDFPe - 0.05 mL/kg (n=6)	1 of 6 (16.7%)	6 of 6 (100%)	1 of 6
DDFPe - 0.10 mL/kg (n=6)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
DDFPe - 0.17 mL/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
DDFPe Total (n=18)	1 of 18 (5.6%)	15 of 18 (83.3%)	1 of 18

Limitations and caveats (from the sponsor): Limitations of the current study primarily concern the exploratory aim toward efficacy, which was greatly underpowered for any purpose other than designing the next study. As with any phase I trial, the small number of cases may only demonstrate side effects and complications that are common.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31349978Culp WC, Onteddu SS, Brown A, Nalleballe K, Sharma R, Skinner RD, Witt T, Roberson PK, Marsh JD. Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial. J Vasc Interv Radiol. 2019 Aug;30(8):1244-1250.e1. doi: 10.1016/j.jvir.2019.04.020.
Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation TrialLink provided by the sponsor.

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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.

William Culp, MD principal investigator

University of Arkansas

Sanjeeva Onteddu, MD principal investigator

University of Arkansas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.05 mL/kg DDFPe, 0.10 mL/kg DDFPe and 0.17 mL/kg DDFPe in people with Ischemic Stroke, run by NuvOx LLC at 1 site 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities (time frame: 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963376, which also lists 1 linked publication.

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 24 Sep 2021.