A Phase 2/3 interventional study of Scopolamine and Placebo in Motion Sickness, sponsored by Repurposed Therapeutics, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Repurposed Therapeutics, Inc. · Phase 2/3, Interventional, and Treatment
Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.
Part 1: The pharmacokinetic (PK) phase Objective: To determine the bioavailability and amount of scopolamine absorbed after administration of 0.2 mg intranasal scopolamine at regular intervals across 8 hours post- dose.
Hypothesis: Detectable levels of Intranasal scopolamine (INSCOP) will be present in subject plasma within 15 minutes post-dose; mean time to Cmax (maximum plasma concentration) will be less than 1.5 hr.
Part 2: The Efficacy phase Objective: To determine the effectiveness, cognitive performance effects, and medication side-effect profile of 0.2 mg intranasal scopolamine spray as a motion sickness (MS) countermeasure.
Hypothesis: The primary hypothesis is that the INSCOP spray will be more efficacious against MS than placebo, without statistically significant cognitive performance side-effects. Specifically, participants will tolerate significantly more provocative head tilts in the INSCOP condition than in the placebo condition.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 63 is close to the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Repurposed Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.2 mg intranasal scopolamine, single dose
Drug: Scopolamine
placebo intranasal (0.1 mg per nostril), single dose
Drug: Placebo
Efficacy: Number of Head Movements During Rotation
During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).
Time frame: 40 min
This study enrolled subjects who were active-duty military or reserves on active duty status between the ages of 18 and 59 from the Wright-Patterson Air Force Base located in Dayton, Ohio. The last subjects completed in August 2015.
| Milestone | PK: Scopolamine Only, Open-label | Efficacy: Scopolamine, Then Placebo | Efficacy: Placebo, Then Scopolamine |
|---|---|---|---|
| Started | 13 | 10 | 13 |
| Completed | 13 | 10 | 12 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).
| Number of head tilts | PK: Scopolamine Only, Open-label | Efficacy: Scopolamine and Placebo (Crossover, Double-blind) |
|---|---|---|
| Head Tilts: Scopolamine Condition | — | 222.5 ± 105 |
| Head Tilts: Placebo Condition | — | 191.7 ± 95.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PK: Scopolamine Only, Open-label | 0/13 (0%) | 0/13 (0%) | 11/13 (84.6%) |
| Efficacy: Scopolamine (Crossover, Double-blind) | 0/23 (0%) | 0/23 (0%) | 18/23 (78.3%) |
| Efficacy: Placebo (Crossover, Double-blind) | 0/23 (0%) | 0/23 (0%) | 19/23 (82.6%) |
| Event | PK: Scopolamine Only, Open-label | Efficacy: Scopolamine (Crossover, Double-blind) | Efficacy: Placebo (Crossover, Double-blind) |
|---|---|---|---|
| Nonserious AEsGeneral disorders | 11/13 | 18/23 | 19/23 |
| Age, Categorical(Participants) | PK: Scopolamine Only, Open-label | Efficacy: All Study Participants (Crossover, Double-Blind) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 23 | 36 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | PK: Scopolamine Only, Open-label | Efficacy: All Study Participants (Crossover, Double-Blind) | Total |
|---|---|---|---|
| Mean | 30.31 ± 12.59 | 30.96 ± 10.86 | 30.72 ± 11.16 |
| Sex: Female, Male(Participants) | PK: Scopolamine Only, Open-label | Efficacy: All Study Participants (Crossover, Double-Blind) | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 10 | 17 | 27 |
| Region of Enrollment(Participants) | PK: Scopolamine Only, Open-label | Efficacy: All Study Participants (Crossover, Double-Blind) | Total |
|---|---|---|---|
| United States | 13 | 23 | 36 |
Plan to share: No
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Studies of the drug tested here: Scopolamine
Repurposed Therapeutics, Inc.