Effect of Metaxalone 640 mg (M640) on Driving, Cognition, and EEG Dynamics Compared to Tizanidine 8 mg in Adults
Assessment of the Effect of Metaxalone Tablets, 640 mg (M640) on Driving Ability, Cognition, and Electroencephalographic (EEG) Dynamics Compared to Tizanidine 8 mg in Adult Participants: A Prospective, Single-blind, Within-subject Study
Participant takes a single pill after eating, takes a driving test on a simulator, takes thought and concentration computerized tests
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The study evaluates effects of a single-dose of M640 mg compared to a single dose of tizanidine 8 mg on driving, cognition, sleepiness, and brain activity in healthy adults
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: James Lukban, D.O.
- Telefonnummer: 480-483-1410
- E-post: jlukban@primusrx.com
Studera Kontakt Backup
- Namn: Manar Shahbandar
- Telefonnummer: 4804831410
- E-post: mshahbandar@primusrx.com
Studieorter
-
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85253
- Perseverance Research Center, LLC
-
Huvudutredare:
- Allan Block, MD
-
Kontakt:
- Nicole C Hank
- Telefonnummer: 4804716132
- E-post: nhank@prcresearcheducation.com
-
Kontakt:
- Laura Christians
- Telefonnummer: 4804716132
- E-post: lchristians@prcresearcheducation.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults, aged ≥ 18 and ≤ 65 years of age at the time of consent.
- Weigh at least 120 pounds at Screening/Baseline and Baseline.
- Medically healthy
- Able to take oral medication.
- Possesses a valid driver's license.
Exclusion Criteria:
- Current use of any medications known to affect sleep-wake cycle.
- Has a sleep disorder.
- Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids
- Known history of alcohol or substance use disorder
- Participants with a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia.
- Participants with a history of seizure disorder or epilepsy.
- Participants with scalp conditions, dermatologic disease, or hair/scalp characteristics
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Active metaxalone 640 mg
metaxalone 640 mg tablets, one dose only |
micronized metaxalone 640 mg pill
Andra namn:
|
|
Aktiv komparator: Active tizanidine 8 mg
tizanidine 8 mg tablets, one dose only |
muscle relaxer for spasms
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline to Tmax in Standard Deviation of Lateral Position as evaluated by Driving Simulation Software
Tidsram: Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
A hardware and software setup that recreates the experience of driving a real vehicle and measures performance at the time of maximum concentration of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
|
Change from Baseline to Tmax in Cognition as assessed by Creyos Cognitive Testing (CCT).
Tidsram: Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
Computerized thinking assessment to objectively measure brain function at the time of maximum concentration of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline to Tmax in Degree of point-in-time drowsiness as measured by the Karolinska Sleepiness Scale (KSS).
Tidsram: Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours
|
Measure at Tmax (metaxalone 4 hours and tizanidine 1.5 hours post dose) Scale: 1 = Extremely alert, 2 = Very alert, 3 = Alert, 4 = Rather alert, 5 = Neither alert nor sleepy, 6 = Some signs of sleepiness, 7 = Sleepy, but no effort to keep awake, 8 = Sleepy, some effort to keep awake, 9 = Very sleepy, great effort to keep awake, fighting sleep |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours
|
|
Change from Baseline to Tmax in electroencephalograph measures
Tidsram: Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
Placement of a non-invasive headset with saline filled, padded electrodes on the participant's scalp to measure brain activity with eyes open and closed at the time of maximum dose of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: James Lukban, DO, Primus Pharmaceuticals, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PMDAC-02
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