Clinical trial NCT03814733: Assessment of Effect of Rapastinel on Driving Performance
Official title: A Phase 1, Randomized, Double-blind, Double-dummy, Placebo-controlled, 5-period, Crossover Study Assessing the Effects of Rapastinel Compared to Alprazolam, Ketamine, and Placebo on Simulated Driving Performance in Normal Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Driving Performance
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2019-01-24
Enrollment: 107
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.


Eligibility criteria: Inclusion Criteria

* Participant possesses a valid driver's license and is an active driver. Drives a minimum of 5,000 miles (about 8,000 km) per year for the previous 3 years.
* Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).

Exclusion Criteria

* A history within 2 years of, or current intervention for, a sleeping disorder (including excessive snoring, obstructive sleep apnea) or a chronic painful condition that interferes with the participant's sleep.
* A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the investigator.
* Participant has traveled across 1 or more time zones (transmeridian travel) in the 14 days before study intervention or is expected to travel across 1 or more time zones during the study.
* Expected to work on a rotating shift during their participation in the study.
* Participant works a night shift.

Primary outcomes:
measure: Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)
timeFrame: Day 1 of each intervention
Secondary outcomes:
measure: simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)
timeFrame: Day 1 of each intervention
measure: Karolinska Sleepiness Scale (KSS)
timeFrame: Day 1 of each intervention
measure: Self-perceived safety to drive ("Right now do you feel safe to drive?)
timeFrame: Day 1 of each intervention
measure: Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance
timeFrame: Day 1 of each intervention
measure: CogScreen SDC Test
timeFrame: Day 1 of each intervention
measure: Proportion of abnormal lane exceedance events
timeFrame: Day 1 of each intervention
measure: Average Speed (mph)
timeFrame: Day 1 of each intervention
measure: Total collisions
timeFrame: Day 1 of each intervention
measure: Number of exceeded cornering speed threshold events
timeFrame: Day 1 of each intervention
measure: Divided attention: average number of correct responses
timeFrame: Day 1 of each intervention
measure: Divided attention: average number of errors
timeFrame: Day 1 of each intervention
measure: Divided attention: average reaction time
timeFrame: Day 1 of each intervention
measure: Rapastinel blood plasma concentration
timeFrame: Day 1 of each intervention
measure: Adverse Events
timeFrame: Up to 66 days
measure: Proportion of abnormal electrocardiograms
timeFrame: Up to 66 days
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Up to 66 days
Other outcomes:
Locations:
city: San Clemente
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Aurora
country: Canada
facility: Algorithme Pharma
state: Ontario
Study officials:
affiliation: Allergan
name: Sheng Fang Su
role: STUDY_DIRECTOR
References:
citation: Su S, Kay G, Hochadel T, Rojo J, Christopher Stein J, Boinpally R, Periclou A. A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance. Clin Transl Sci. 2022 Jan;15(1):255-266. doi: 10.1111/cts.13145. Epub 2021 Nov 7.