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

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ClinicalTrials.gov Identifier: NCT02153632
Recruitment Status : Terminated
First Posted : June 3, 2014
Results First Posted : April 2, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Osmotica Pharmaceutical US LLC

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 240mg Amantadine HCl ER Tablets 320mg Amantadine HCl ER Tablets Placebo Tablets for Amantadine
Hide 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
Arm/Group Title 240mg Amantadine HCl ER Tablets 320mg Amantadine HCl ER Tablets Placebo Tablets for Amantadine Total
Hide 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
Hide 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
1.Primary Outcome
Title Unified Dyskinesia Rating Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title 240mg Amantadine HCl ER Tablets 320mg Amantadine HCl ER Tablets Placebo Tablets for Amantadine
Hide 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
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
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
-15.2  (15.58) -13.7  (10.95) -9.0  (10.62)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
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
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
2.3  (3.25) 3.6  (3.93) 1.6  (3.56)
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
Hide 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%)    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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: Osmotica Pharmaceutical US LLC
ClinicalTrials.gov Identifier: NCT02153632     History of Changes
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: April 12, 2019