Clinical trial • Phase II • Neurology
temazepam for Insomnia
Phase II trial of temazepam for Insomnia.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Insomnia
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-03-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
Randomised, open-label, two temazepam 20 mg tablet formulations (test vs reference), single dose, randomized crossover design (single centre)-controlled, crossover Phase II trial in Czechia.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Two temazepam 20 mg tablet formulations (test vs reference), single dose, randomized crossover design (single centre)
- Crossover
- Yes
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent provided in the record.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 2
- Consent Approach
- No information provided on informed consent or assent in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Czechia
- Earliest CTIS Part Ii Submission Date
- 25-03-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 41
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Komenskeho 19, Severni Predmesti
- Department Name
- Clinic
- Contact Person Name
- Jolana Herejkova
- Contact Person Email
- herejkova@cepha.cz
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Orion Corporation
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- temazepam 20 mg tablet (formulation 1 - test)
- Active Substance
- temazepam
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg
- Frequency
- single dose
- Maximum Dose
- 20 mg
- Investigational Product Name
- temazepam 20 mg tablet (formulation 2 - reference)
- Active Substance
- temazepam
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg
- Frequency
- single dose
- Maximum Dose
- 20 mg
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