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NCT03814733
Assessment of Effect of Rapastinel on Driving Performance
Phase 1 trial testing Rapastinel in Driving Performance in 107 participants. Completed in 3 April 2019.
29 March 2019
Quick facts
| Lead sponsor | Naurex, Inc, an affiliate of Allergan plc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | other |
| Enrollment | 107 |
| Start date | 5 November 2018 |
| Primary completion | 29 March 2019 |
| Estimated completion | 3 April 2019 |
| Sites | 2 locations across Canada, United States |
Drugs / interventions tested
- Rapastinel — full drug profile →
- Alprazolam
- Ketamine (ketamine) — full drug profile →
- Rapastinel Matched Placebo — full drug profile →
- Alprazolam Matched Placebo — full drug profile →
- Ketamine Matched Placebo
Conditions studied
- Driving Performance — all drugs for Driving Performance →
Sponsor
Naurex, Inc, an affiliate of Allergan plc — full company profile →
Who can join
Adults 21 to 65, any sex, with Driving Performance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fluoroethylnormemantine, A Novel Derivative of Memantine, Facilitates Extinction Learning Without Sensorimotor Deficits.
Chen BK, Le Pen G, Eckmier A, Rubinstenn G, et al · · 2021 · cited 11× · PMID 33631001 · DOI 10.1093/ijnp/pyab007 -
A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance.
Su S, Kay G, Hochadel T, Rojo J, et al · · 2022 · cited 8× · PMID 34423904 · DOI 10.1111/cts.13145
Verify or expand the search:
- PubMed search for NCT03814733
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rapastinel
Trials testing the same drug.
- NCT03855865 — Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD) · Phase 3 · withdrawn
- NCT03799900 — Assessment of Abuse Potential of Rapastinel in Humans · Phase 1 · completed
- NCT03675776 — Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD) · Phase 3 · terminated
- NCT03668600 — Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD) · Phase 3 · terminated
- NCT03614156 — Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD) · Phase 3 · terminated
Other recruiting trials for Driving Performance
Currently open trials in the same condition.
- NCT07176208 — Clinical Study to Evaluate the Effects of Oral Delta-9-tetrahydrocannabinol (Δ9-THC) With and Without Alcohol on Percept · Phase 1 · recruiting
- NCT06686914 — The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex · Phase 1 · recruiting
Other Naurex, Inc, an affiliate of Allergan plc trials
Trials by the same sponsor.
- NCT03855865 — Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD) · Phase 3 · withdrawn
- NCT03799900 — Assessment of Abuse Potential of Rapastinel in Humans · Phase 1 · completed
- NCT03675776 — Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD) · Phase 3 · terminated
- NCT03668600 — Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD) · Phase 3 · terminated
- NCT03614156 — Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD) · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03814733 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Naurex, Inc, an affiliate of Allergan plc
- Last refreshed: 11 July 2019
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/NCT03814733.
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