Driving PerformancePhase 1NCT03814733
Assessment of Effect of Rapastinel on Driving Performance
A Phase 1 study testing Rapastinel, Alprazolam and Ketamine in people with Driving Performance, run by Naurex, Inc, an affiliate of Allergan plc at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Performance
- What is being tested?
- Rapastinel, Alprazolam and Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Nov 2018to 3 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Collaborative Neuroscience Network
San Clemente, California, 92673
About this study
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
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.
- Conditions
- Driving Performance
- Being tested
- Rapastinel, Alprazolam, Ketamine, Rapastinel Matched Placebo, Alprazolam Matched Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapastinelDrug
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
AlprazolamDrug
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
KetamineDrug
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Rapastinel Matched PlaceboDrug
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Alprazolam Matched PlaceboDrug
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Ketamine Matched PlaceboDrug
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
| Study group | Role | What they receive |
|---|---|---|
| Rapastinel High Dose | Experimental | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Rapastinel |
| Rapastinel Low Dose | Experimental | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Rapastinel |
| Alprazolam | Active comparator | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Alprazolam |
| Ketamine | Active comparator | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Ketamine |
| Placebo for Rapastinel | Placebo comparator | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Rapastinel Matched Placebo |
| Placebo for Alprazolam | Placebo comparator | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Alprazolam Matched Placebo |
| Placebo for Ketamine | Placebo comparator | Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. Receives: Drug: Ketamine Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)
Measured: Day 1 of each intervention
Secondary outcomes (16)
simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)
Measured: Day 1 of each intervention
Karolinska Sleepiness Scale (KSS)
The KSS is a participant self-reported measure of situational sleepiness and provides an assessment of alertness/sleepiness. The KSS is a 9-point categorical scale, where 1 = "extremely alert" and 9 = "extremely sleepy-fighting sleep".
Measured: Day 1 of each intervention
Self-perceived safety to drive ("Right now do you feel safe to drive?)
Measured: Day 1 of each intervention
Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance
Measured: Day 1 of each intervention
CogScreen SDC Test
Measured: Day 1 of each intervention
Proportion of abnormal lane exceedance events
Measured: Day 1 of each intervention
Average Speed (mph)
Measured: Day 1 of each intervention
Total collisions
Measured: Day 1 of each intervention
Number of exceeded cornering speed threshold events
Measured: Day 1 of each intervention
Divided attention: average number of correct responses
Participants are asked to answer periodic questions during the driving simulation.
Measured: Day 1 of each intervention
Divided attention: average number of errors
Participants are asked to answer periodic questions during the driving simulation.
Measured: Day 1 of each intervention
Divided attention: average reaction time
Measured: Day 1 of each intervention
Rapastinel blood plasma concentration
Measured: Day 1 of each intervention
Adverse Events
Measured: Up to 66 days
Proportion of abnormal electrocardiograms
Measured: Up to 66 days
Columbia-Suicide Severity Rating Scale
The C-SSRS is a clinician-ratedinstrument that reports theseverity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe).
Measured: Up to 66 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start5 Nov 2018
- Primary completion29 Mar 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Driving PerformanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheng Fang Su, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814733
- Sponsor's protocol ID
- RAP-PK-18
- Status last verified
- Jul 2019
- First submitted
- 15 Nov 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34423904
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03814733
- Acronym / sponsor ID
- RAP-PK-18
- Conditions
- Driving Performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Rapastinel High Dose | Experimental | Drug: RapastinelParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
| Rapastinel Low Dose | Experimental | Drug: RapastinelParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
| Alprazolam | Active comparator | Drug: AlprazolamParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
| Ketamine | Active comparator | Drug: KetamineParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
| Placebo for Rapastinel | Placebo comparator | Drug: Rapastinel Matched PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
| Placebo for Alprazolam | Placebo comparator | Drug: Alprazolam Matched PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
| Placebo for Ketamine | Placebo comparator | Drug: Ketamine Matched PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| RapastinelParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. | Drug | Rapastinel High Dose, Rapastinel Low Dose |
| AlprazolamParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. | Drug | Alprazolam |
| KetamineParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. | Drug | Ketamine |
| Rapastinel Matched PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. | Drug | Placebo for Rapastinel |
| Alprazolam Matched PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. | Drug | Placebo for Alprazolam |
| Ketamine Matched PlaceboParticipants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner. | Drug | Placebo for Ketamine |
Primary outcome
Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)
Time frame: Day 1 of each intervention
16 secondary outcomes
simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)
Time frame: Day 1 of each intervention
Karolinska Sleepiness Scale (KSS)
Time frame: Day 1 of each intervention
Self-perceived safety to drive ("Right now do you feel safe to drive?)
Time frame: Day 1 of each intervention
Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance
Time frame: Day 1 of each intervention
CogScreen SDC Test
Time frame: Day 1 of each intervention
Proportion of abnormal lane exceedance events
Time frame: Day 1 of each intervention
Average Speed (mph)
Time frame: Day 1 of each intervention
Total collisions
Time frame: Day 1 of each intervention
Number of exceeded cornering speed threshold events
Time frame: Day 1 of each intervention
Divided attention: average number of correct responses
Time frame: Day 1 of each intervention
Divided attention: average number of errors
Time frame: Day 1 of each intervention
Divided attention: average reaction time
Time frame: Day 1 of each intervention
Rapastinel blood plasma concentration
Time frame: Day 1 of each intervention
Adverse Events
Time frame: Up to 66 days
Proportion of abnormal electrocardiograms
Time frame: Up to 66 days
Columbia-Suicide Severity Rating Scale
Time frame: Up to 66 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 34423904Su 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.
- Individual participant dataSharing planned: Undecided
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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.
Sheng Fang Su study director
Allergan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rapastinel, Alprazolam and Ketamine in people with Driving Performance, run by Naurex, Inc, an affiliate of Allergan plc at 2 sites in 2 countries.
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 2 inclusion and 5 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam) (time frame: Day 1 of each intervention). 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 NCT03814733, 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 11 Jul 2019.