Who is sponsoring NCT04314713?

NCT04314713 is sponsored by Battelle Memorial Institute.

What drugs are being tested in NCT04314713?

Interventions in NCT04314713: Scopolamine Hydrobromide Trihydrate.

What condition does NCT04314713 study?

NCT04314713 studies Medical Countermeasures, Organophosphate Poisoning.

Is NCT04314713 still recruiting?

NCT04314713 is currently terminated. Last updated 19 February 2025.

Are results published for NCT04314713?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-19 · How we verify

NCT04314713

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Intramuscular Administration of Scopolamine

Terminated Phase 1 Results posted Last updated 19 February 2025

What this trial tests

Phase 1 trial testing Scopolamine Hydrobromide Trihydrate in Medical Countermeasures in 32 participants. Terminated before completion.

Timeline

2 June 2020

Primary endpoint
6 April 2021

6 May 2021

Quick facts

Lead sponsor	Battelle Memorial Institute
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	32
Start date	2 June 2020
Primary completion	6 April 2021
Estimated completion	6 May 2021
Sites	1 location across United States

Drugs / interventions tested

Scopolamine Hydrobromide Trihydrate — full drug profile →

Conditions studied

Medical Countermeasures — all drugs for Medical Countermeasures →
Organophosphate Poisoning — all drugs for Organophosphate Poisoning →

Sponsor

Battelle Memorial Institute

Who can join

Adults 18 to 55, any sex, with Medical Countermeasures or Organophosphate Poisoning. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Determine Degree and Number of Adverse Events Experienced by Subjects. Primary · 30 Days (+7)

Safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection

Adverse Events : Subjects with at least 1 AE

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	6
Cohort 2 Scopolamine HBT 0.007 mg/kg	5
Cohort 3 Scopolamine HBT 0.011 mg/kg	6
Cohort 4 Scopolamine HBT 0.014 mg/kg	6
Placebo	5

Somnolence

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	2
Cohort 2 Scopolamine HBT 0.007 mg/kg	3
Cohort 3 Scopolamine HBT 0.011 mg/kg	6
Cohort 4 Scopolamine HBT 0.014 mg/kg	5
Placebo	1

Dizziness

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	2
Cohort 2 Scopolamine HBT 0.007 mg/kg	4
Cohort 3 Scopolamine HBT 0.011 mg/kg	3
Cohort 4 Scopolamine HBT 0.014 mg/kg	6
Placebo	0

Headache

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	3
Cohort 2 Scopolamine HBT 0.007 mg/kg	0
Cohort 3 Scopolamine HBT 0.011 mg/kg	1
Cohort 4 Scopolamine HBT 0.014 mg/kg	2
Placebo	0

Injection site pain

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	1
Cohort 2 Scopolamine HBT 0.007 mg/kg	2
Cohort 3 Scopolamine HBT 0.011 mg/kg	2
Cohort 4 Scopolamine HBT 0.014 mg/kg	2
Placebo	3

Injection site paraesthesia

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	2
Cohort 2 Scopolamine HBT 0.007 mg/kg	1
Cohort 3 Scopolamine HBT 0.011 mg/kg	0
Cohort 4 Scopolamine HBT 0.014 mg/kg	2
Placebo	2

Injection site hypoaesthesia

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	1
Cohort 2 Scopolamine HBT 0.007 mg/kg	0
Cohort 3 Scopolamine HBT 0.011 mg/kg	1
Cohort 4 Scopolamine HBT 0.014 mg/kg	2
Placebo	2

Dry mouth

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	4
Cohort 2 Scopolamine HBT 0.007 mg/kg	3
Cohort 3 Scopolamine HBT 0.011 mg/kg	2
Cohort 4 Scopolamine HBT 0.014 mg/kg	1
Placebo	0

Cmax of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

Cmax of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	0.67	± 0.286
Cohort 2 Scopolamine HBT 0.007 mg/kg	1.07	± 0.529
Cohort 3 Scopolamine HBT 0.011 mg/kg	1.53	± 0.501
Cohort 4 Scopolamine HBT 0.014 mg/kg	1.91	± 0.455

Tmax of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

Tmax of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	1	± 0.4
Cohort 2 Scopolamine HBT 0.007 mg/kg	1	± 0.8
Cohort 3 Scopolamine HBT 0.011 mg/kg	1	± 0.6
Cohort 4 Scopolamine HBT 0.014 mg/kg	1	± 0.5

Apparent Volume of Distribution (mL/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

Apparent Volume of Distribution (mL/kg) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	6258	± 1678.1
Cohort 2 Scopolamine HBT 0.007 mg/kg	5552	± 1710.3
Cohort 3 Scopolamine HBT 0.011 mg/kg	5963	± 970.8
Cohort 4 Scopolamine HBT 0.014 mg/kg	10210	± 4402.5

t1/2 (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

t1/2 (hr) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	1.99	± 0.235
Cohort 2 Scopolamine HBT 0.007 mg/kg	1.88	± 0.207
Cohort 3 Scopolamine HBT 0.011 mg/kg	2.10	± 0.535
Cohort 4 Scopolamine HBT 0.014 mg/kg	4.47	± 2.876

Apparent Clearance (mL/hr/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

Apparent Clearance (mL/hr/kg) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	2177	± 545.6
Cohort 2 Scopolamine HBT 0.007 mg/kg	2100	± 805.2
Cohort 3 Scopolamine HBT 0.011 mg/kg	2012	± 253.9
Cohort 4 Scopolamine HBT 0.014 mg/kg	1765	± 375.4

MRT (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

MRT (hr) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	3.18	± 0.647
Cohort 2 Scopolamine HBT 0.007 mg/kg	3.02	± 0.639
Cohort 3 Scopolamine HBT 0.011 mg/kg	3.01	± 0.355
Cohort 4 Scopolamine HBT 0.014 mg/kg	3.81	± 0.802

AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

AUClast (hr\*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	2.36	± 0.499
Cohort 2 Scopolamine HBT 0.007 mg/kg	3.67	± 1.293
Cohort 3 Scopolamine HBT 0.011 mg/kg	5.47	± 0.694
Cohort 4 Scopolamine HBT 0.014 mg/kg	8.16	± 1.940

AUCinfinity (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

AUCinfinity (hr\*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	2.4	± .5
Cohort 2 Scopolamine HBT 0.007 mg/kg	3.7	± 1.32
Cohort 3 Scopolamine HBT 0.011 mg/kg	5.5	± .68
Cohort 4 Scopolamine HBT 0.014 mg/kg	8.3	± 1.98

Cmax/Dose (ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

Cmax/Dose (ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	133	± 57.3
Cohort 2 Scopolamine HBT 0.007 mg/kg	153	± 75.6
Cohort 3 Scopolamine HBT 0.011 mg/kg	139	± 45.5
Cohort 4 Scopolamine HBT 0.014 mg/kg	137	± 32.5

AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection. Primary · 30 Days (+7)

AUCinfinity/Dose (hr\*ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.

Group	Value	95% CI
Cohort 1 Scopolamine HBT 0.005 mg/kg	481	± 100.3
Cohort 2 Scopolamine HBT 0.007 mg/kg	535	± 188.6
Cohort 3 Scopolamine HBT 0.011 mg/kg	504	± 62.5
Cohort 4 Scopolamine HBT 0.014 mg/kg	590	± 140.4

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs/SAEs were collected from time of dosing through 30 days (+7) after dosing.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 Scopolamine HBT 0.005 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2 Scopolamine HBT 0.007 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3 Scopolamine HBT 0.011 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 4 Scopolamine HBT 0.014 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 5 Scopolamine HBT 0.021 mg/kg

Serious: 0

Deaths: 0

Placebo

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (8 terms — click to expand)

Reaction	System	Cohort 1 Scopolamine HBT 0…	Cohort 2 Scopolamine HBT 0…	Cohort 3 Scopolamine HBT 0…	Cohort 4 Scopolamine HBT 0…	Cohort 5 Scopolamine HBT 0…	Placebo
Somnolence	Nervous system disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—
Delirium	Psychiatric disorders	—	—	—	—	—	—
Injection site paraesthesia	General disorders	—	—	—	—	—	—
Injection site hypoaesthesia	General disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04314713 adverse events section.

Sponsor's own description

To characterize the safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection. And characterize the pharmacokinetics (PK) of ascending doses of Scopolamine HBT administered by IM injection

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04314713 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Battelle Memorial Institute
Last refreshed: 19 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04314713.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04314713

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other Battelle Memorial Institute trials

Verify against primary sources