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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: James Lukban, D.O.
- Telefonnummer: 480-483-1410
- E-post: jlukban@primusrx.com
Studer Kontakt Backup
- Navn: Manar Shahbandar
- Telefonnummer: 4804831410
- E-post: mshahbandar@primusrx.com
Studiesteder
-
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Arizona
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Scottsdale, Arizona, Forente stater, 85253
- Perseverance Research Center, LLC
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Hovedetterforsker:
- Allan Block, MD
-
Ta kontakt med:
- Nicole C Hank
- Telefonnummer: 4804716132
- E-post: nhank@prcresearcheducation.com
-
Ta kontakt med:
- Laura Christians
- Telefonnummer: 4804716132
- E-post: lchristians@prcresearcheducation.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Active metaxalone 640 mg
metaxalone 640 mg tablets, one dose only |
micronized metaxalone 640 mg pill
Andre navn:
|
|
Aktiv komparator: Active tizanidine 8 mg
tizanidine 8 mg tablets, one dose only |
muscle relaxer for spasms
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline to Tmax in Standard Deviation of Lateral Position as evaluated by Driving Simulation Software
Tidsramme: 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).
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline to Tmax in Degree of point-in-time drowsiness as measured by the Karolinska Sleepiness Scale (KSS).
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: James Lukban, DO, Primus Pharmaceuticals, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PMDAC-02
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