Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID (ALLAY-LID-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02153632

Recruitment Status : Terminated

First Posted : June 3, 2014

Results First Posted : April 2, 2019

Last Update Posted : February 16, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Adamas Pharmaceuticals, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Parkinson's Disease Levodopa Induced Dyskinesia (LID)
Interventions	Drug: amantadine HCl ER Drug: Placebo
Enrollment	135

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	240mg Amantadine HCl ER Tablets	320mg Amantadine HCl ER Tablets	Placebo Tablets for Amantadine
Arm/Group Description	Amantadine Hydrogen Chloride (HCl) ...	Amantadine HCl ER Tablets 320mg dai...	Placebo Tablets matching Amantadine...
Arm/Group Description	Amantadine Hydrogen Chloride (HCl) ER Tablets 240mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks. Placebo
Period Title: Overall Study
Started	45	46	44
Completed	27	27	25
Not Completed	18	19	19

Baseline Characteristics

Arm/Group Title		240mg Amantadine HCl ER Tablets	320mg Amantadine HCl ER Tablets	Placebo Tablets for Amantadine	Total
Arm/Group Description		Amantadine HCl ER Tablets 240mg dai...	Amantadine HCl ER Tablets 320mg dai...	Placebo Tablets matching Amantadine...	Total of all reporting groups
Arm/Group Description		Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks. Placebo	Total of all reporting groups
Overall Number of Baseline Participants		45	46	44	135
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	45 participants	46 participants	44 participants	135 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	45 100.0%	46 100.0%	44 100.0%	135 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	45 participants	46 participants	44 participants	135 participants
		63.9 (8.88)	63.0 (8.98)	63.5 (10.36)	63.5 (9.36)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	45 participants	46 participants	44 participants	135 participants
	Female	16 35.6%	21 45.7%	18 40.9%	55 40.7%
	Male	29 64.4%	25 54.3%	26 59.1%	80 59.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	45 participants	46 participants	44 participants	135 participants
Canada		3	1	2	6
United States		15	23	23	61
France		10	7	8	25
Germany		7	6	6	19
Spain		10	9	5	24

Outcome Measures

1.Primary Outcome


Title	Unified Dyskinesia Rating Scale
Description	The Unified Dyskinesia Rating Scale is a validated tool for assessment...
Description	The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia and pain from dystonia. The minimum (better) value is 0 and the maximum (worse) value is 130.
Time Frame	Change from baseline to Day 98

Outcome Measure Data

Analysis Population Description

Intent to treat population


Arm/Group Title		240mg Amantadine HCl ER Tablets	320mg Amantadine HCl ER Tablets	Placebo Tablets for Amantadine
Arm/Group Description:		Amantadine HCl ER Tablets 240mg dai...	Amantadine HCl ER Tablets 320mg dai...	Placebo Tablets matching Amantadine...
Arm/Group Description:		Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks. Placebo
Overall Number of Participants Analyzed		45	46	44
Mean (Standard Deviation) Unit of Measure: score on a scale
Visit 2 (Baseline)	Number Analyzed	44 participants	45 participants	44 participants
Visit 2 (Baseline)		41.3 (13.91)	36.3 (12.40)	40.7 (13.98)
Visit 7 (Day 98)/Stable Dose LOCF [1]	Number Analyzed	41 participants	43 participants	37 participants
Visit 7 (Day 98)/Stable Dose LOCF [1]		41.3 (13.98)	36.3 (12.40)	40.7 (13.98)
Mean Change from Baseline (SD)	Number Analyzed	41 participants	43 participants	37 participants
Mean Change from Baseline (SD)		-15.2 (15.58)	-13.7 (10.95)	-9.0 (10.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	240mg Amantadine HCl ER Tablets
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.031
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 95% -10.5 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.75
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	320mg Amantadine HCl ER Tablets
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95% -11.5 to -1.5
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.71
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Mobility State Self-Assessment - Subject Diary Cards
Description	hange from baseline in the number of awake hours without troublesome d...
Description	hange from baseline in the number of awake hours without troublesome dyskinesia (involuntary movements). Every half hour the subject will indicate in the diary if the medication has ("ON") or has not ("OFF") produced benefits in terms of mobility, slowness and rigidity. Valid diaries of the 3 consecutive days prior to each visit will be averaged with respect to the number of awake hours without troublesome dyskinesia. The change from baseline in the number of waking hours that subjects report being "ON" without troublesome dyskinesias will be analyzed at analysis visits Day 14 and Day 98 of treatment. Higher scores mean a better outcome and the maximum value is 24 hours.
Time Frame	Day 14 and Day 98 of treatment

Outcome Measure Data

Analysis Population Description

The number analyzed is the number of subjects with values at each time point.


Arm/Group Title		240mg Amantadine HCl ER Tablets	320mg Amantadine HCl ER Tablets	Placebo Tablets for Amantadine
Arm/Group Description:		Amantadine HCl ER Tablets 240mg dai...	Amantadine HCl ER Tablets 320mg dai...	Placebo Tablets matching Amantadine...
Arm/Group Description:		Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)	Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks. Placebo
Overall Number of Participants Analyzed		45	46	44
Mean (Standard Deviation) Unit of Measure: Hours
Visit 2 (Baseline)	Number Analyzed	43 participants	45 participants	39 participants
Visit 2 (Baseline)		10.4 (3.76)	9.8 (3.48)	9.1 (3.48)
Visit 7 (Day 98)/Stable Dose LOCF [1]	Number Analyzed	45 participants	46 participants	44 participants
Visit 7 (Day 98)/Stable Dose LOCF [1]		12.7 (3.91)	13.3 (3.83)	11.1 (4.03)
Mean Change in Hours from Baseline (SD)	Number Analyzed	45 participants	46 participants	44 participants
Mean Change in Hours from Baseline (SD)		2.3 (3.25)	3.6 (3.93)	1.6 (3.56)

Adverse Events

Time Frame	26 weeks
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	240mg Amantadine HCl ER Tablets		320mg Amantadine HCl ER Tablets		Placebo Tablets for Amantadine
Arm/Group Description	Amantadine HCl ER Tablets 240mg dai...		Amantadine HCl ER Tablets 320mg dai...		Placebo Tablets matching Amantadine...
Arm/Group Description	Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)		Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase. Amantadine HCl ER (ALLAY-LID II)		Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks. Placebo
All-Cause Mortality
	240mg Amantadine HCl ER Tablets		320mg Amantadine HCl ER Tablets		Placebo Tablets for Amantadine
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/45 (0.00%)		0/46 (0.00%)		0/44 (0.00%)
Serious Adverse Events Serious Adverse Events
	240mg Amantadine HCl ER Tablets		320mg Amantadine HCl ER Tablets		Placebo Tablets for Amantadine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/45 (2.22%)		4/46 (8.70%)		6/44 (13.64%)
Gastrointestinal disorders
constipation hemorrhoids ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Infections and infestations
vestibular neuronitis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
brain abscess ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Injury, poisoning and procedural complications
thoracic vertebral fracture ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Metabolism and nutrition disorders
contipation diabetes mellitus inadequate control ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Musculoskeletal and connective tissue disorders
osteoarthritis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
lumbar spinal stenosis ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
intervertebral disc protrusion ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Nervous system disorders
cranial nerve palsies multiple ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
transient ischaemic attack ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Vascular disorders
hypertension ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
1 Term from vocabulary, MedDRA (17.1) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	240mg Amantadine HCl ER Tablets		320mg Amantadine HCl ER Tablets		Placebo Tablets for Amantadine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/45 (80.00%)		38/46 (82.61%)		29/44 (65.91%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Cardiac disorders
Heart valve incompetence ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Tachycardia ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Ear and labyrinth disorders
Hypoacusis ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Vertigo ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Endocrine disorders
Hypothyroidism ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Eye disorders
Eye pruritus ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Vision Blurred ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Gastrointestinal disorders
Abdominal distension ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Abdominal pain ^† 1	2/45 (4.44%)	2	0/46 (0.00%)	0	0/44 (0.00%)	0
Abdominal pain upper ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Constipation ^† 1	2/45 (4.44%)	2	2/46 (4.35%)	2	2/44 (4.55%)	2
Diarrhea ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Dry mouth ^† 1	4/45 (8.89%)	4	5/46 (10.87%)	5	0/44 (0.00%)	0
Dyspepsia ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Gastritis ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Hemorrhoids ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Nausea ^† 1	6/45 (13.33%)	6	6/46 (13.04%)	6	1/44 (2.27%)	1
Vomiting ^† 1	1/45 (2.22%)	1	2/46 (4.35%)	2	0/44 (0.00%)	0
General disorders
Asthenia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Fatigue ^† 1	0/45 (0.00%)	0	3/46 (6.52%)	3	4/44 (9.09%)	4
Gait disturbance ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Malaise ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Oedema peripheral ^† 1	0/45 (0.00%)	0	4/46 (8.70%)	4	1/44 (2.27%)	1
Pyrexia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Allergy to arthropod sting ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Infections and infestations
Acute sinusitis ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Brain abscess ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Bronchitis ^† 1	0/45 (0.00%)	0	2/46 (4.35%)	2	1/44 (2.27%)	1
Conjunctivitis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Cystitis ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Groin abscess ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Influenza ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Nasopharyngitis ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Oral candidiasis ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Pharyngitis ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Pulpitis dental ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Sinusitis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	2/44 (4.55%)	2
Tracheitis ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Upper respiratory tract infection ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Urinary tract infection ^† 1	3/45 (6.67%)	3	5/46 (10.87%)	5	3/44 (6.82%)	3
Vestibular neuronitis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Viral infection ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Vulvovaginal mycotic infection ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Neutrophil count increased ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Red blood cells urine positive ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Urinary casts present ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Urine leukocyte esterase positive ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Injury, poisoning and procedural complications
Fall ^† 1	5/45 (11.11%)	5	4/46 (8.70%)	4	5/44 (11.36%)	5
Ligament sprain ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Muscle strain ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Post-traumatic pain ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Radius fracture ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Rib fracture ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
thoracic vertebral fracture ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Investigations
Bacterial test positive ^† 1	2/45 (4.44%)	2	0/46 (0.00%)	0	0/44 (0.00%)	0
Blood alkaline phosphatase increased ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Blood Chloesterol increased ^† 1	2/45 (4.44%)	2	0/46 (0.00%)	0	0/44 (0.00%)	0
Blood pressure increased ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Blood test abnormal ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Blood thyroid stimulating hormone decreased ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Blood urea increased ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Blood urine present ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Creatinine renal clearance increased ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Crystal urine present ^† 1	1/45 (2.22%)	1	2/46 (4.35%)	2	1/44 (2.27%)	1
Electrocardiogram QT Shortened ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Electrocadiogram T wave abnormal ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Electrocardiogram abnormal ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Hemoglobin urine present ^† 1	1/45 (2.22%)	1	3/46 (6.52%)	3	0/44 (0.00%)	0
Laboratory test abnormal ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Lymphocyte count decreased ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Mean cell hemoglobin concentration decreased ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Urine ketone body present ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Weight decreased ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Weight increased ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
White blood cells urine positive ^† 1	0/45 (0.00%)	0	2/46 (4.35%)	2	0/44 (0.00%)	0
Metabolism and nutrition disorders
Abnormal loss of weight ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Decreased appetite ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Diabetes mellitus ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Diabetes mellitus inadequate control ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Food Craving ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
hypercholesterolaemia ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	3/45 (6.67%)	3	1/46 (2.17%)	1	0/44 (0.00%)	0
Back Pain ^† 1	2/45 (4.44%)	2	1/46 (2.17%)	1	0/44 (0.00%)	0
Bursitis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Intervertebral disc protusion ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Joint swelling ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Lumbar spinal stenosis ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Mobility decreased ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
muscle spasm ^† 1	2/45 (4.44%)	2	3/46 (6.52%)	3	1/44 (2.27%)	1
musculoskeletal chest pain ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
musculoskeletal pain ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Osteoarthritis ^† 1	1/45 (2.22%)	1	2/46 (4.35%)	2	0/44 (0.00%)	0
Pain in extremity ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	1/44 (2.27%)	1
Temporomandibular join syndrome ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Trigger finger ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Nervous system disorders
Action tremor ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Akinesia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	1/44 (2.27%)	1
Amnesia ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Autonomic nervous system imbalance ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Bradykinesia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Circadian rhythm sleep disorder ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Cranial nerve palsies multiple ^† 1	0/45 (0.00%)	0	2/46 (4.35%)	2	0/44 (0.00%)	0
Dizziness ^† 1	3/45 (6.67%)	3	2/46 (4.35%)	2	0/44 (0.00%)	0
Dizziness postural ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Drooling ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Dysaesthesia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Dysarthria ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Dyskinesia ^† 1	5/45 (11.11%)	5	3/46 (6.52%)	3	3/44 (6.82%)	3
Dystonia ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Freezing phenomenon ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
headache ^† 1	2/45 (4.44%)	2	3/46 (6.52%)	3	0/44 (0.00%)	0
Hyperaesthesia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Hypoaesthesia ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	1/44 (2.27%)	1
Mental impairment ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Paraesthesia ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Parkinson's disease ^† 1	3/45 (6.67%)	3	0/46 (0.00%)	0	1/44 (2.27%)	1
Sciatica ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Somnolence ^† 1	3/45 (6.67%)	3	0/46 (0.00%)	0	4/44 (9.09%)	4
Transient ischaemic attack ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Tremor ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Psychiatric disorders
Abnormal dreams ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Anxiety ^† 1	2/45 (4.44%)	2	1/46 (2.17%)	1	2/44 (4.55%)	2
Confusional state ^† 1	3/45 (6.67%)	3	1/46 (2.17%)	1	1/44 (2.27%)	1
Depression ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	2/44 (4.55%)	2
Hallucination ^† 1	1/45 (2.22%)	1	2/46 (4.35%)	2	1/44 (2.27%)	1
Hallucination, visual ^† 1	3/45 (6.67%)	3	2/46 (4.35%)	2	1/44 (2.27%)	1
Hallucinations, mixed ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Illusion ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Impulsive behaviour ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Insomnia ^† 1	1/45 (2.22%)	1	2/46 (4.35%)	2	2/44 (4.55%)	2
Libido decreased ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Libido increased ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Middle insomnia ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Nightmare ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Obsessive-compulsive disorder ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Rapid eye movements sleep abnormal ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1
Sleep attacks ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Sleep disorder ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Renal and urinary disorders
Dysuria ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Haemoglobinuria ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Urinary incontinence ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Urinary retention ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Urine abnormality ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Reproductive system and breast disorders
Prostatitis ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	1/44 (2.27%)	1
Epistaxis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Respiratory tract congestion ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Throat tightness ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermal cyst ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Hyperhidrosis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Livedo reticularis ^† 1	0/45 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0
Panniculitis ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Rash ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	1/44 (2.27%)	1
Vascular disorders
Haematoma ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
Hypertension ^† 1	1/45 (2.22%)	1	2/46 (4.35%)	2	0/44 (0.00%)	0
Hypotension ^† 1	1/45 (2.22%)	1	1/46 (2.17%)	1	0/44 (0.00%)	0
Orthostatic hypotension ^† 1	2/45 (4.44%)	2	1/46 (2.17%)	1	2/44 (4.55%)	2
Peripheral venous disease ^† 1	0/45 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1
Varicophebitis ^† 1	1/45 (2.22%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0
1 Term from vocabulary, MedDRA (17.1) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Investigator shall allow SPONSOR 60 days to review any manuscript and 30 days to review any poster presentation, abstract or any other written or oral material which discloses the Study Results. SPONSOR may request in writing an additional 60 days for review.

SPONSOR may remove all Confidential Information from any publications or presentations, or if deemed not sufficient to protect its Intellectual Property Rights, then SPONSOR may embargo the publication or presentation.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	George Wagner, VP of Regulatory Affairs
Organization:	Osmotica Pharmaceuticals
Phone:	9088091357
EMail:	gwagner@osmotica.ccom

Layout table for additonal information

Responsible Party:	Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT02153632
Other Study ID Numbers:	OS320-3006
First Submitted:	May 30, 2014
First Posted:	June 3, 2014
Results First Submitted:	December 21, 2018
Results First Posted:	April 2, 2019
Last Update Posted:	February 16, 2022

To Top