At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Cyclobenzaprine 10 Mg Oral Tablet +1 moredrug
Likely dose
Cyclobenzaprine 10 Mg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Driving Simulation Cross-Over Study of Sedative Effects of Tolperisone Compared to Cyclobenzaprine and Placebo
In Brief
A Phase 1 clinical trial evaluating Cyclobenzaprine 10 Mg Oral Tablet and Placebo Oral Tablet for Driving Impaired. Completed, enrolled 35 participants across 2 sites.
Detailed Summary
This is a randomized blinded study to assess the sedative effect of 150 mg TID tolperisone and 10 mg TID cyclobenzaprine compared to placebo on simulated driving performance and cognitive functioning in healthy adult volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDriving Impaired
CountriesUnited States
CollaboratorsCognitive Research Corporation
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartJul 2017
First PostedNov 2017
Primary CompletionDec 2017
Study CompletionJan 2018
TodayJul 2026
First PostedNov 27, 2017
Enrollment StartJul 31, 2017
Primary CompletionDec 6, 2017
Study CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.6 years ago
Interventions
Cyclobenzaprine 10 Mg Oral Tabletdrug
cyclobenzaprine 10 mg tablets
Placebo Oral Tabletdrug
sugar pill