Extended Release Amantadine Safety and Efficacy Study in... | NCT01397422

NCT01397422

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Placebo Comparator		Drug: ADS-5102 (extended release amantadine HCl)
Treatment B	Active Comparator	Low dose ADS-5102 (amantadine extended release)	Drug: ADS-5102 (extended release amantadine HCl)
Treatment C	Active Comparator	A mid-dose ADS-5102 (amantadine extended release)	Drug: ADS-5102 (extended release amantadine HCl)
Treatment D	Active Comparator	High dose ADS-5102 (amantadine extended release)	Drug: ADS-5102 (extended release amantadine HCl)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADS-5102 (extended release amantadine HCl)	Drug	Oral capsules to be administered once daily at bedtime, for 8 weeks	Treatment A Treatment B Treatment C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8	The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.	Baseline (Day 1) and Week 8

Secondary Outcomes

Measure	Description	Time Frame
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8	The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.	Baseline (Day 1) and Week 8

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials Director	Adamas Pharmaceuticals, Inc.	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
FG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG00221 subjectsOf the 3 participants who discontinued, 1 withdrew due to both an AE and an eGFR \< 50 mL/min/1.73m\^2

Safety Analysis Population (all randomized subjects who received ≥ 1 dose of study drug)

Arm/Group Information

ID	Title	Description
BG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
BG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
BG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
BG003	ADS-5102 (420 mg)	420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.5± 10.17 BG00167.5± 8.59 BG00264.7± 10.03 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG00112 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0012 BG002

Fatigue Severity Score (FSS)

The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0004.86± 1.211 BG001

Hoehn and Yahr Score

Hoehn and Yahr assessed at screening only. The scale, from 1-5, describes the patient's PD progression. The higher the score the more severe the symptoms of PD.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0002.5± 0.7 BG001

Time since PD diagnosis

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00010.66± 7.057 BG0018.94± 3.395 BG002

Levodopa daily dose

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000801.1± 431.94 BG001714.5± 449.33 BG002

Duration of LID

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0004.08± 4.051 BG0013.35± 2.585 BG002

Subjects taking Antiparkinson Medication

Participants may have been taking more than 1 antiparkinson medication at baseline.

Count of Participants

Participants

Title

Denominators

Categories

Levodopa (Sinemet or Stalevo)

Title	Measurements
	BG00022 BG00120

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8

The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.

Participants in the MITT population with available data were analyzed.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
OG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
OG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
OG003	ADS-5102 (420 mg)	420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)

Units	Counts
Participants	OG00022 OG00119 OG00220 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-6.7± 2.68 OG001-12.3± 2.88 OG002-17.9± 2.82 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG002	20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.	ANCOVA	Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.	0.0051		Least Squares Mean Difference	-11.3			2-Sided	95	-19.1	-3.5					Superiority

Secondary

Change in the Fatigue Severity Score (FSS) From Baseline to Week 8

MITT population

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
OG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
OG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
OG003	ADS-5102 (420 mg)	420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)

Secondary

Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8

UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.

MITT Population

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
OG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
OG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
OG003	ADS-5102 (420 mg)

Secondary

Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary

A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.

MITT population

Posted

Least Squares Mean

Standard Error

hours

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
OG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
OG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
OG003

Secondary

Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8

The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.

MITT population

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
OG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
OG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
OG003	ADS-5102 (420 mg)	420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)

Secondary

Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8

The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement).

MITT population

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 8

ID	Title	Description
OG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
OG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
OG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
OG003	ADS-5102 (420 mg)

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks	22	0	22	18	22
EG001	ADS-5102 (260 mg)	260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks	20	1	20	16	20
EG002	ADS-5102 (340 mg)	340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)	21	0	21	20	21
EG003	ADS-5102 (420 mg)	420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)	20	4	20	18	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypersensitivity	Immune system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG0031 affected20 at risk
Cellulitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Urinary tract Infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Mental Status Change	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG0031 affected20 at risk
Angina pectoris	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Vision blurred	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Altered visual depth perception	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Dry eye	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Eye irritation	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Photophobia	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected22 at risk EG0017 affected20 at risk EG0025 affected21 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0013 affected20 at risk EG0024 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0023 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Oedema peripheral	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0022 affected21 at risk EG003
Asthenia	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0023 affected21 at risk EG003
Malaise	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Chills	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Irritability	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Pain	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0022 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0003 affected22 at risk EG0011 affected20 at risk EG0023 affected21 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0012 affected20 at risk EG0020 affected21 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0021 affected21 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Blood urea increased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Blood creatinine increased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Blood glucose increased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Blood pressure increased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Liver function test abnormal	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0013 affected20 at risk EG0026 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0023 affected21 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Somnolence	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected22 at risk EG0010 affected20 at risk EG0021 affected21 at risk EG003
Syncope	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Intracranial pressure increased	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0013 affected20 at risk EG0023 affected21 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0011 affected20 at risk EG0023 affected21 at risk EG003
Hallucination	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0022 affected21 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Hallucination, auditory	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Nightmare	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Paranoia	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Abnormal dreams	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0021 affected21 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0022 affected21 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Pyuria	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0021 affected21 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected20 at risk EG0020 affected21 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hyperhydrosis	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Orthostatic hypertension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected22 at risk EG0010 affected20 at risk EG0020 affected21 at risk EG003

ID	Term
D020820	Dyskinesias
D010300	Parkinson Disease
D020734	Parkinsonian Disorders

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases

420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)

Facility	Status	City	State	ZIP	Country	Contacts
		Sun City	Arizona		United States