A study to evaluate the safety and efficacy of sublingual cannabinoid based medicineextract compared with placebo for the treatment of Insomnia

Zelda Therapeutics Limited0 sites24 target enrollmentJanuary 18, 2018

ConditionsInsomnia Neurological - Other neurological disorders

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Insomnia
Sponsor: Zelda Therapeutics Limited
Enrollment: 24
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2018

End Date

March 19, 2020

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Zelda Therapeutics Limited

Eligibility Criteria

Inclusion Criteria

•a)Has provided a dated informed consent form signed by them; and
•b)Is willing to comply with all study procedures and be available for the duration of the study; and
•c)Male or female aged 25 – 70 years ; and
•d)Presence of chronic insomnia defined as self\-reported difficulty initiating (latency to persistent sleep \>30 min) and/or maintaining sleep (\>30 mins awake, or waking \>30 mins before desired waking time)) on three or more nights per week) for at least 3 months; and
•e)Insomnia Severity Index score \>10

Exclusion Criteria

•a)Untreated cardiovascular disease, arrhythmias (other than well controlled atrial fibrillation), hypertension or severe heart failure; or
•b)History of allergies particularly to plant\-based products containing terpenes, ie flavours and aromatic natural oils for example citrus, mango, lavender, thyme, cedarwood and pine products; or
•c)Known hypersensitivity to cannabinoids; or
•d)Currently regularly using (greater than or equal to 3 nights/days per week) psychotropic or CNS\-active drugs (including cannabis, opioids, benzodiazepines); or
•e)Inability to refrain from use of psychotropic or CNS\-active drugs (including cannabis, opioids, benzodiazepines) for at least one week prior to and duration of study; or
•f)Inability to refrain from use of Cytochrome P450 inhibitors for at least one week prior to and duration of study. Examples include macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), protease inhibitors (ritonavir, telaprevir, boceprevir), calcium channel blockers (amlopdipine), high cholesterol medication (gemfibrozil), cyclosporine, danazol, tachycardia medication (amiodarone), hypertension medication (verapamil, diltiazem), niacin (vitamin B3 greater than 1g/ day), grapefruit juice; or
•g)Untreated metabolic disorders such as diabetes; or
•h)Presence of severe depression, severe anxiety or other severe psychopathologic conditions based on self\-report or depression scores on the DASS greater than or equal to 21, or anxiety scores on the DASS greater than or equal to 16; or
•i)History of suicide attempt or current suicide ideation (response greater than 0 to Question 9 of PHQ\-9\); or
•j)History of seizures or epilepsy; or