CClinicalTrials.gg
Sign In
CompletedNCT04103034Updated Mar 18, 2024Results posted

A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers

A Phase 1 interventional study of BT200 and Desmopressin in Cerebrovascular Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis) and Intracranial Arteriosclerosis, sponsored by Band Therapeutics. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Band Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design. This Phase 1 study will comprise 4 sub-parts: Part A, a single ascending dose (SAD) study; Part B, a multiple ascending dose (MAD) study; Part C, a desmopressin challenge study to explore (i) whether desmopressin could be used as an antidote, and/or (ii) whether desmopressin stimulated vonWillebrand Factor (VWF) release is overcome with increasing BT200 doses; and Part D, a relative bioavailability (BA) study.

The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.

02

Conditions studied

  • Cerebrovascular Stroke
  • Large-Artery Atherosclerosis (Embolus/Thrombosis)
  • Intracranial Arteriosclerosis

Keywords

  • Secondary Stroke Prevention
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 112 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Band Therapeutics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male or female volunteers, age ≥ 18 years old at screening
  2. If female, must be post-menopausal or status post hysterectomy
  3. Able to comprehend and to give informed consent
  4. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures

Exclusion criteria

Exclusion Criteria:

  1. Clinically significant medical history (including von Willebrand Disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study
  2. Clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities
  3. History of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions
  4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
  5. Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the subject's welfare or the integrity of the study's results
  6. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    BT200 0.18mg

    Subjects will receive a single subcutaneous dose of BT200 0.18mg

    Drug: BT200

  • Experimental
    BT200 0.6mg

    Subjects will receive a single subcutaneous dose of BT200 0.6mg

    Drug: BT200

  • Experimental
    BT200 1.8mg

    Subjects will receive a single subcutaneous dose of BT200 1.8mg

    Drug: BT200

  • Experimental
    BT200 6.0mg

    Subjects will receive a single subcutaneous dose of BT200 6.0mg

    Drug: BT200

  • Experimental
    BT200 12.0mg

    Subjects will receive a single subcutaneous dose of BT200 12.0mg

    Drug: BT200

  • Experimental
    BT200 24.0mg

    Subjects will receive a single subcutaneous dose of BT200 24.0mg

    Drug: BT200

  • Experimental
    BT200 24.0mg rep

    Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion

    Drug: BT200

  • Placebo comparator
    Placebo SAD

    Subjects will receive a single subcutaneous dose of placebo

    Drug: Placebo

  • Experimental
    BT200 loading dose 12.0mg, maintenance doses of 12.0 mg

    Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg

    Drug: BT200

  • Experimental
    BT200 loading doses 24.0mg, maintenance doses of 24.0 mg

    Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg

    Drug: BT200

  • Placebo comparator
    Placebo MAD

    Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo

    Drug: Placebo

  • Experimental
    BT200 48.0mg + desmopressin challenge

    Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200

    Drug: BT200 · Drug: Desmopressin

  • Placebo comparator
    Placebo + desmopressin challenge dose

    Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo

    Drug: BT200 · Drug: Desmopressin

  • Placebo comparator
    Placebo infusion

    Subjects will receive a single IV dose of placebo administered over 24 hours

    Drug: Placebo

  • Experimental
    BT200 36.0mg

    Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion

    Drug: BT200

  • Experimental
    BT200 48.0 mg

    Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion

    Drug: BT200

  • Experimental
    BT200 18.0 mg

    Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion

    Drug: BT200

  • Experimental
    BT200 24mg IV infusion

    Subjects will receive a single IV dose of BT200 24mg administered over 24 hours

    Drug: BT200

Interventions

  • DrugBT200

    BT200 is a PEGylated synthetic RNA oligonucleotide

  • DrugDesmopressin

    Sterile solution for injection

    Also known as: MINIRIN® Injection

  • DrugPlacebo

    Sterile saline for injection

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

    Any AE or bleeding event related to study treatment

    Time frame: Baseline through 8 weeks after dosing up to 56 days

Secondary outcomes

  1. Measured Area Under the Curve (AUC)

    Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose

    Time frame: Baseline through 8 weeks after dosing up to 56 days

  2. Maximum Plasma Concentration (Cmax)

    Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d

    Time frame: Baseline through 8 weeks after dosing up to 56 days

  3. Time to Maximum Plasma Concentration (Tmax)

    Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d

    Time frame: Baseline through 8 weeks after dosing up to 56 days

07

Results

Posted Mar 18, 2024

Participant flow

Subjects were recruited from the Medical University of Vienna Phase 1 Unit's database of Normal Human Volunteers and a recruitment vendor was also employed.

Participant flow — Overall Study
MilestoneBT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
Started6666666206646226666
Completed6666666196026225466
Not completed000000010620001200

Outcome measures

PrimaryNumber of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Any AE or bleeding event related to study treatment

Time frame:
Baseline through 8 weeks after dosing up to 56 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
ParticipantsBT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0010110124333000320
SecondaryMeasured Area Under the Curve (AUC)

Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose

Time frame:
Baseline through 8 weeks after dosing up to 56 days
Reported as:
Mean · h*ug/mL
Measured Area Under the Curve (AUC)
h*ug/mLBT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepBT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mgBT200 48.0mg + Desmopressin ChallengeBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
Measured Area Under the Curve (AUC)1.159 ± 0.725945.405 ± 2.111311.50 ± 6.566364.39 ± 22.534161.6 ± 43.427259.5 ± 99.216265.3 ± 59.127409.4 ± 32.347806.8 ± 187.25675.9 ± 204.80366.2 ± 78.610638.8 ± 90.467220.3 ± 64.58555.4 ± 126.99
SecondaryMaximum Plasma Concentration (Cmax)

Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d

Time frame:
Baseline through 8 weeks after dosing up to 56 days
Reported as:
Mean · ug/mL
Maximum Plasma Concentration (Cmax)
ug/mLBT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepBT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mgBT200 48.0mg + Desmopressin ChallengeBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
Maximum Plasma Concentration (Cmax)0.01025 ± 0.00554590.04688 ± 0.0185220.09432 ± 0.0359640.5087 ± 0.184301.258 ± 0.355402.092 ± 0.076272.080 ± 0.462173.013 ± 0.251855.823 ± 1.36066.598 ± 2.67193.248 ± 117245.525 ± 0.954291.742 ± 0.495455.037 ± 1.3953
SecondaryTime to Maximum Plasma Concentration (Tmax)

Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d

Time frame:
Baseline through 8 weeks after dosing up to 56 days
Reported as:
Mean · (h)
Time to Maximum Plasma Concentration (Tmax)
(h)BT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepBT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mgBT200 48.0mg + Desmopressin ChallengeBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
Time to Maximum Plasma Concentration (Tmax)111.867 ± 111.701880.433 ± 20.238572.364 ± 22.0757100.239 ± 53.443372.761 ± 21.4536100.247 ± 38.514688.517 ± 19.769729.892 ± 25.884512.811 ± 17.9877105.919 ± 18.9321139.647 ± 46.6683107.892 ± 113.4475100.247 ± 38.514623.864 ± 0.2642

Adverse events

Collected over Adverse events were collected from time of screening up to 56 days post dose. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BT200 0.18mg0/6 (0%)0/6 (0%)4/6 (66.7%)
BT200 0.6mg0/6 (0%)0/6 (0%)3/6 (50%)
BT200 1.8mg0/6 (0%)0/6 (0%)4/6 (66.7%)
BT200 6.0mg0/6 (0%)0/6 (0%)4/6 (66.7%)
BT200 12.0mg0/6 (0%)0/6 (0%)5/6 (83.3%)
BT200 24.0mg0/6 (0%)0/6 (0%)6/6 (100%)
BT200 24.0mg Rep0/6 (0%)1/6 (16.7%)5/6 (83.3%)
Placebo SAD0/20 (0%)1/20 (5%)16/20 (80%)
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg0/6 (0%)0/6 (0%)6/6 (100%)
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg0/6 (0%)1/6 (16.7%)6/6 (100%)
Placebo MAD0/4 (0%)0/4 (0%)4/4 (100%)
BT200 48.0mg + Desmopressin Challenge0/6 (0%)0/6 (0%)5/6 (83.3%)
Placebo + Desmopressin Challenge Dose0/2 (0%)0/2 (0%)1/2 (50%)
Placebo Infusion0/2 (0%)0/2 (0%)1/2 (50%)
BT200 36.0mg0/6 (0%)0/6 (0%)4/6 (66.7%)
BT200 48.0 mg0/6 (0%)1/6 (16.7%)4/6 (66.7%)
BT200 18.0 mg0/6 (0%)0/6 (0%)5/6 (83.3%)
BT200 24mg IV Infusion0/6 (0%)0/6 (0%)4/6 (66.7%)
Most frequent serious events
Most frequent serious events
EventBT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
Humerus fractureInjury, poisoning and procedural complications0/60/60/60/60/60/61/60/200/60/60/40/60/20/20/60/60/60/6
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/60/60/60/60/60/60/60/200/60/60/40/60/20/20/61/60/60/6
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/60/60/60/60/60/60/60/200/61/60/40/60/20/20/60/60/60/6
Back painMusculoskeletal and connective tissue disorders0/60/60/60/60/60/60/61/200/60/60/40/60/20/20/60/60/60/6
Most frequent other events
Showing 10 of 70
Most frequent other events
EventBT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT200 24mg IV Infusion
HeadacheNervous system disorders3/60/62/61/61/62/60/66/204/61/60/44/60/20/20/63/60/60/6
NasopharyngitisInfections and infestations2/62/61/60/62/62/63/65/200/60/60/40/60/21/22/60/63/62/6
Abdominal pain uppeGastrointestinal disorders0/60/60/60/60/60/60/60/200/60/60/40/61/20/20/60/61/61/6
ToothacheGastrointestinal disorders0/60/61/60/60/60/60/60/200/60/60/41/60/21/20/60/60/60/6
HematomaVascular disorders0/60/60/61/61/60/60/60/200/62/62/42/60/20/20/61/60/60/6
GastroenteritisInfections and infestations0/60/62/60/60/60/60/60/200/60/60/40/60/20/20/60/60/60/6
ArthralgiaMusculoskeletal and connective tissue disorders1/60/61/60/62/60/60/60/200/60/61/40/60/20/20/60/60/60/6
EpistaxisRespiratory, thoracic and mediastinal disorders0/60/60/60/60/60/61/60/200/60/60/41/60/20/20/62/60/60/6
Back painMusculoskeletal and connective tissue disorders0/61/60/60/60/60/61/61/200/60/61/40/60/20/21/61/60/60/6
DiarrheaGastrointestinal disorders0/60/61/60/60/60/60/60/201/61/61/40/60/20/20/60/61/60/6

Baseline characteristics

Safety population

Age, Categorical
Age, Categorical(Participants)BT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT 200 24mg IV InfusionTotal
<=18 years0000100101000000003
Between 18 and 65 years6666566196546226666109
>=65 years0000000000000000000
Sex: Female, Male
Sex: Female, Male(Participants)BT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT 200 24mg IV InfusionTotal
Female10200022101100010011
Male5646664185635226566101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT 200 24mg IV InfusionTotal
Hispanic or Latino0000000000000000000
Not Hispanic or Latino6666666206646226666112
Unknown or Not Reported0000000000000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT 200 24mg IV InfusionTotal
American Indian or Alaska Native0000000000000000000
Asian0001000001000100115
Native Hawaiian or Other Pacific Islander0000000000000000000
Black or African American1000000000000000001
White5665666206546216655106
More than one race0000000000000000000
Unknown or Not Reported0000000000000000000
Region of Enrollment
Region of Enrollment(participants)BT200 0.18mgBT200 0.6mgBT200 1.8mgBT200 6.0mgBT200 12.0mgBT200 24.0mgBT200 24.0mg RepPlacebo SADBT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mgBT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mgPlacebo MADBT200 48.0mg + Desmopressin ChallengePlacebo + Desmopressin Challenge DosePlacebo InfusionBT200 36.0mgBT200 48.0 mgBT200 18.0 mgBT 200 24mg IV InfusionTotal
Austria6666666206646226666112
08

Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
09

References and documents

Publications

  • Buchtele N, Schwameis M, Gilbert JC, Schorgenhofer C, Jilma B. Targeting von Willebrand Factor in Ischaemic Stroke: Focus on Clinical Evidence. Thromb Haemost. 2018 Jun;118(6):959-978. doi: 10.1055/s-0038-1648251. Epub 2018 May 30. PubMed 29847840 ↗
  • Kovacevic KD, Grafeneder J, Schorgenhofer C, Gelbenegger G, Gager G, Firbas C, Quehenberger P, Jilma-Stohlawetz P, Bileck A, Zhu S, Gilbert JC, Beliveau M, Jilma B, Derhaschnig U. The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial. Haematologica. 2022 Sep 1;107(9):2121-2132. doi: 10.3324/haematol.2021.279948. PubMed 34818873 ↗
  • Denis CV, Lenting PJ. How to keep the factor VIII/von Willebrand factor complex in the circulation. Haematologica. 2022 Sep 1;107(9):2011-2013. doi: 10.3324/haematol.2021.280222. No abstract available. PubMed 34818875 ↗

Study documents

  • Study protocol · Apr 22, 2020
  • Statistical analysis plan · Sep 17, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04103034
Lead sponsor
Band Therapeutics
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Oct 7, 2019
Primary completion
Sep 14, 2020
Completion
Sep 14, 2020
Results posted
Mar 18, 2024
Last update
Mar 18, 2024

Study contacts

James C Gilbert, MD
study director · Band Therapeutics
Ulla Derhaschnig, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke→

Start the discussion