Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities (N-AND)
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|ClinicalTrials.gov Identifier: NCT05273320|
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : April 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Intellectual Disability Developmental Disability Aggression Behavior Problem||Drug: Nabilone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Pre-pilot Open-label Clinical Trial of Nabilone for Severe Behavioural Problems (Aggression) in Adults With Intellectual and Developmental Disabilities|
|Actual Study Start Date :||March 17, 2022|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||March 31, 2024|
Experimental: Open Label
Titration: Nabilone p.o., increased in 0.25 mg increments every 2 days to a maximum of 1 mg b.i.d.
Open label: Nabilone p.o. at maximum dose tolerated for 28 days Tapering: Nabilone p.o. decreased in 0.25 decrements per day
Nabilone capsules at a maximum dose of 1 mg twice a day
Other Name: 02392925 Teva-Nabilone 0.25 mg Capsule; 02384892 Teva-Nabilone 1 mg Capsule
- Incidence of Treatment-Emergent Physical Adverse Events Assessed by the UKU Side Effect Rating Scale [Safety and Tolerability] [ Time Frame: From the titration phase (Week 1) to the safety visit (Week 9) ]Solicited/Unsolicited Physical Adverse Events
- Change From Baseline in Aggression Assessed by Aberrant Behavioral Checklist-Irritability Subscale (ABC-I) at Week 6 [ Time Frame: Baseline; Week 6 ]Aberrant Behavioral Checklist-Irritability subscale (ABC-I): The ABC is a 58-item rating scale completed by a caregiver. It consists of 5 subscales. Among them, the Irritability subscale consists of 15 items.
- Change From Baseline in Aggression Assessed by Modified Overt Aggression Scale (MOAS) at Week 6 [ Time Frame: Baseline; Week 6 ]Modified Overt Aggression Scale (MOAS) is a reliable measure used to measure behavioural problems in adults with IDD. It consisted of 4 items and is administered by the researcher's interview with the caregiver.
- Change From Baseline in Clinician Global Impressions - Severity (CGI-S) Score at Week 6 [ Time Frame: Baseline; Week 6 ]CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment relative to the clinician's experience with participants who had the same diagnosis. This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.
- Clinical Global Impressions - Improvement (CGI-I) Score at Week 6 [ Time Frame: Baseline; Week 6 ]CGI-I is a 7-point scale that requires the clinician to assess how much a participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention. This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273320
|Contact: Research Analyst||416-535-8501 ext email@example.com|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M6J 1H4|
|Contact: Research Analyst 4165358501 ext 37832 firstname.lastname@example.org|
|Principal Investigator: Hsiang-Yuan Lin, MD|
|Principal Investigator:||Hsiang-Yuan Lin, MD||Centre for Addiction and Mental Health, Toronto, Ontario, Canada|