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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03393520




Registration number
NCT03393520
Ethics application status
Date submitted
3/01/2018
Date registered
8/01/2018
Date last updated
4/06/2020

Titles & IDs
Public title
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Secondary ID [1] 0 0
2017-001339-38
Secondary ID [2] 0 0
17-AVP-786-305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in Patients With Dementia of the Alzheimer's Type 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - AVP-786

Placebo Comparator: Placebo - Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.

Experimental: AVP-786; Dose 1 - Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.

Experimental: AVP-786; Dose 2 - Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.


Treatment: Drugs: Placebo
oral capsules

Treatment: Drugs: AVP-786
oral capsules

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Timepoint [1] 0 0
Baseline; Week 12
Secondary outcome [1] 0 0
Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score
Timepoint [1] 0 0
Baseline; Week 12
Secondary outcome [2] 0 0
Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score
Timepoint [2] 0 0
Baseline; Week 12
Secondary outcome [3] 0 0
Change from Baseline to Week 12 in the NPI Caregiver Distress Score
Timepoint [3] 0 0
Baseline; Week 12
Secondary outcome [4] 0 0
Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score
Timepoint [4] 0 0
Baseline; Week 12
Secondary outcome [5] 0 0
Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score
Timepoint [5] 0 0
Baseline; Week 12
Secondary outcome [6] 0 0
Change from Baseline to Week 12 in the NPI Total Score
Timepoint [6] 0 0
Baseline; Week 12
Secondary outcome [7] 0 0
Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score
Timepoint [7] 0 0
Baseline; Week 12
Secondary outcome [8] 0 0
Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating
Timepoint [8] 0 0
Baseline; Week 12
Secondary outcome [9] 0 0
Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score
Timepoint [9] 0 0
Baseline; Week 12
Secondary outcome [10] 0 0
Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score
Timepoint [10] 0 0
Baseline; Week 12
Secondary outcome [11] 0 0
Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores
Timepoint [11] 0 0
Baseline; Week 12
Secondary outcome [12] 0 0
Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score
Timepoint [12] 0 0
Baseline; Week 12

Eligibility
Key inclusion criteria
- Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National
Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria

- Participants with clinically significant, moderate/severe agitation at the time of
screening and for at least 2 weeks prior to randomization that interferes with their
daily routine and for which a prescription medication has been indicated, in the
opinion of the investigator

- The diagnosis of agitation must meet the provisional consensus definition of agitation
in participants with cognitive disorders developed by the International
Psychogeriatric Association (IPA) Agitation Definition Work Group.

- A Clinical Global Impression of Severity of Illness scale for Agitation
(CGIS-Agitation) score of = 4 (moderately ill) at screening and baseline

- Participants must have a reliable caregiver who is able and willing to comply with
study procedures, including not administering any prohibited medications during the
course of the study.

- Caregiver who is able and willing to comply with all required study procedures. In
order to qualify as a reliable informant (i.e., caregiver) capable of assessing
changes in participant's condition during the study, the individual must spend a
minimum of 2 hours per day for 4 days per week with the participant.
Minimum age
50 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular
dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)

- Participants with symptoms of agitation that are not secondary to AD (e.g., secondary
to pain, other psychiatric disorder, or delirium)

- Participants with co-existent clinically significant or unstable systemic diseases
that could confound the interpretation of the safety results of the study (e.g.,
malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable
pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated
cardiomyopathy, or unstable valvular heart disease)

- Participants with myasthenia gravis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australian Alzheimer's Research Foundation - Nedlands
Recruitment hospital [2] 0 0
Neuro Trials Victoria Pty Ltd - Noble Park
Recruitment hospital [3] 0 0
The Alfred Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Noble Park
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
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Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
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United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Pleven
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Ruse
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Veliko Tarnovo
Country [19] 0 0
Czechia
State/province [19] 0 0
Brno
Country [20] 0 0
Czechia
State/province [20] 0 0
Hradec Kralové
Country [21] 0 0
Czechia
State/province [21] 0 0
Hradec Králové
Country [22] 0 0
Czechia
State/province [22] 0 0
Kladno
Country [23] 0 0
Czechia
State/province [23] 0 0
Kutná Hora
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha
Country [25] 0 0
Czechia
State/province [25] 0 0
Rychnov nad KneĹžnou
Country [26] 0 0
France
State/province [26] 0 0
Caen cedex 9
Country [27] 0 0
France
State/province [27] 0 0
Calais
Country [28] 0 0
France
State/province [28] 0 0
Dijon Cedex
Country [29] 0 0
France
State/province [29] 0 0
Poitiers
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France
State/province [30] 0 0
Saint-Etienne
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France
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Toulouse
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France
State/province [32] 0 0
Vandoeuvre les Nancy
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Hungary
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Balassagyarmat
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Budapest
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Debrecen
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Esztergom
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Hungary
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Miskolc
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Hungary
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Nyiregyhaza
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Hungary
State/province [39] 0 0
Pecs
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Hungary
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Szeged
Country [41] 0 0
Hungary
State/province [41] 0 0
Székesfehérvár
Country [42] 0 0
Italy
State/province [42] 0 0
Brescia
Country [43] 0 0
Italy
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Chieti
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Italy
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Firenze
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Italy
State/province [45] 0 0
Milano
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Italy
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Monza
Country [47] 0 0
Italy
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Ponderano
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Italy
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Roma
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Poland
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Bydgoszcz
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Chorzów
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Katowice
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Kraków
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Lodz
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Plewiska
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Rosebank
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South Africa
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Umhlanga
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Spain
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Barcelona
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Córdoba
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Elche
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Lleida
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Salamanca
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zamora
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Spain
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Zaragoza
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United Kingdom
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Barnsley
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Bath
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United Kingdom
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Belfast
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United Kingdom
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Blackpool
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Cannock
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United Kingdom
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Leeds
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London
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Manchester
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Northampton
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Prescot
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United Kingdom
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Southampton
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United Kingdom
State/province [85] 0 0
Swindon
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avanir Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786
compared to placebo, for the treatment of agitation in participants with dementia of the
Alzheimer's type.
Trial website
https://clinicaltrials.gov/show/NCT03393520
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fred Ledon
Address 0 0
Country 0 0
Phone 0 0
+1 949 389-6724
Fax 0 0
Email 0 0
FLedon@avanir.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03393520