Clinical Trials Register

Summary
EudraCT Number:	2016-001128-78
Sponsor's Protocol Code Number:	ACP-103-033
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-01-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2016-001128-78

A.3

Full title of the trial

A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects with Alzheimer’s Disease

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

The research study for patients with Alzheimer's disease to examine the safety and efficacy of Pimavanserin for the treatment of symptoms of agitation and aggression

A.4.1

Sponsor's protocol code number

ACP-103-033

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ACADIA Pharmaceuticals Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	ACADIA Pharmaceuticals Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ACADIA Pharmaceuticals Inc.
B.5.2	Functional name of contact point	AD Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	3611 Valley Centre Drive, Suite 300
B.5.3.2	Town/ city	San Diego
B.5.3.3	Post code	CA 92130
B.5.3.4	Country	United States
B.5.6	E-mail	AD_Trial_Info@ACADIA-Pharm.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pimavanserin
D.3.2	Product code	ACP-103
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pimavanserin
D.3.9.1	CAS number	706779-91-1
D.3.9.2	Current sponsor code	ACP-103
D.3.9.3	Other descriptive name	PIMAVANSERIN TARTRATE
D.3.9.4	EV Substance Code	SUB128275
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	17
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pimavanserin
D.3.2	Product code	ACP-103
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pimavanserin
D.3.9.1	CAS number	706779-91-1
D.3.9.2	Current sponsor code	ACP-103
D.3.9.3	Other descriptive name	PIMAVANSERIN TARTRATE
D.3.9.4	EV Substance Code	SUB128275
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Agitation and Aggression in Alzheimer's Disease

E.1.1.1

Medical condition in easily understood language

Patients with Alzheimer's disease with symptoms that include agitation and aggressive behaviors

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10001896
E.1.2	Term	Alzheimer's disease
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety and tolerability of pimavanserin after 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Can understand the nature of the trial and protocol requirements and provide signed informed consent and can understand and sign other forms necessary for participation in the trial (e.g., the Health Insurance
Portability and Accountability Act [HIPAA] authorization form in the United States). The following requirements for consent must be met:
• from the subject, if the subject is deemed competent to provide informed consent
• from an appropriate person according to national and local regulations (e.g. the subject’s legally authorized representative [LAR] with the subject’s assent), if the subject is deemed not competent to provide informed consent
2. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
3. Has a designated study partner/caregiver (e.g., relative, housemate, close personal friend, or professional caregiver) who is in contact with the subject at least 3 times a week on 3 separate days. The study partner/caregiver should:
• be willing and able to accompany the subject to all clinic visits,
• be capable of routinely monitoring and reporting study drug use,
• be regarded by the Investigator as sufficiently informed to report accurately on the subject’s behavioral and functional status.
4. The subject’s study partner/caregiver provides written agreement that they understand the study, including the role of the study partner/caregiver and will participate in the study
5. Both subject and study partner/caregiver are fluent in and able to read the local language in which study assessments are administered at the clinical site
6. Both subject and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
7. Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
8. If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence during the study, and 1 month following completion of the study. Females of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Baseline.

E.4

Principal exclusion criteria

1. Is participating in another clinical trial (other than Study ACP-103-032) of any investigational drug, device, or intervention
2. The Investigator determines that enrollment in the study would be detrimental to a subject’s well-being
3. The Investigator becomes aware of an impending and unexpected change in the subject’s living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver’s home to another) that s/he judges may cause a major disruption in the subject’s behaviour
4. Subject or study partner/caregiver has an uncorrected medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
5. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study
6. Subject was significantly non-compliant in Study ACP-103-032
7. Subject has had a QRS interval <120 ms and whose Fridericia’s corrected QT interval (QTcF) is >460 ms at baseline OR subject has had a QRS interval ≥120 ms and QTcF is >480 ms at Baseline
8. Has clinically significant laboratory abnormalities that in the judgment of the Investigator would jeopardize the safe participation of the subject in the study
9. Subject has become bedridden or has any significant medical condition that is unstable and that would either:
• place the subject at undue risk from study drug or undergoing study procedures;
or
• interfere with the interpretation of safety or efficacy evaluations performed during the course of the study
10. Subject is receiving skilled nursing care for any medical condition other than dementia (skilled nursing care includes procedures that can only be administered by a registered nurse or doctor, such as [but not limited to] intravenous administration of medication, procedures related to insertion or care of suprapubic catheters, and nasopharyngeal/tracheostomy aspiration)
11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator’s assessment of behavior since the last assessment

E.5 End points

E.5.1

Primary end point(s)

Treatment emergent adverse events (TEAEs)

E.5.1.1

Timepoint(s) of evaluation of this end point

Adverse events during ACP-103-033 will be recorded through the follow-up safety assessment approximately 30 days after the last dose of open-label study drug

E.5.2

Secondary end point(s)

Not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Chile

France

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

102

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

There will be subjects that may be unable to give consent and for those people Sponsor has determined that a LAR is acceptable

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

111

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-02-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-02-25

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