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Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. (ALLAY-LID-I)

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: NCT02153645
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 Dyskinesias (LID)
Interventions Drug: 240mg Amantadine HCl ER tablets
Drug: Placebo tablets
Drug: 320mg Amantadine HCl ER tablets
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 240mg Amantadine Hydrochloride (HCl) ER Tablets 320mg Amantadine HCl ER Tablets Placebo Tablets for Amantadine
Hide Arm/Group Description

Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.

Amantadine ER Tablets

Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.

Placebo Tablets for Amantadine ER Tablets

Period Title: Overall Study
Started 30 29 28
Completed 17 19 18
Not Completed 13 10 10
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 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.

Amantadine ER Tablets

Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.

Placebo Tablets for Amantadine ER Tablets

Total of all reporting groups
Overall Number of Baseline Participants 30 29 28 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 28 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
29
 100.0%
28
 100.0%
87
 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 30 participants 29 participants 28 participants 87 participants
68.6  (8.02) 63.3  (9.17) 66.1  (8.04) 66.1  (8.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 28 participants 87 participants
Female
16
  53.3%
10
  34.5%
12
  42.9%
38
  43.7%
Male
14
  46.7%
19
  65.5%
16
  57.1%
49
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 28 participants 87 participants
Canada 1 0 1 2
United States 7 16 8 31
France 8 8 10 26
Germany 6 3 3 12
Spain 8 2 6 16
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 (spasm or cramps) and pain from dystonia, the degree of impairment for each of 7 body parts, and the degree of disability in communication, drinking from a cup, dressing and ambulation. The minimum score is 0 (better) and the maximum score is 130 (worse).
Time Frame From baseline to Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 240 mg Amantadine HCl ER Tablets 320 mg Amantadine HCl ER Tablets Placebo Amantadine HCl ER Tablets
Hide Arm/Group Description:

Amantadine HCl ER Tablets 240 mg daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Tablets 320 mg daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Placebo Tablets daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Overall Number of Participants Analyzed 30 29 28
Mean (Standard Deviation)
Unit of Measure: score on a scale
Visit 2 (Baseline) 46.2  (13.19) 39.2  (11.91) 38.7  (11.23)
Visit 7 (Day 98)/Stable Dose LOCF [1] 27.5  (19.13) 26.4  (13.17) 28.7  (13.70)
Change from Baseline (SD) -18.8  (16.38) -13.3  (13.73) -9.6  (14.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 240 mg Amantadine HCl ER Tablets, 320 mg Amantadine HCl ER Tablets, Placebo Amantadine HCl ER Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-13.9 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 320 mg Amantadine HCl ER Tablets
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-11.2 to 5.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.95
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mobility State Self-Assessment - Subject Diary Cards
Hide Description Change 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 was the number of subjects with values at each time point.
Arm/Group Title 240 mg Amantadine HCl ER Tablets 320 mg Amantadine HCl ER Tablets Placebo Amantadine HCl ER Tablets
Hide Arm/Group Description:

Amantadine HCl ER Tablets 240 mg daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Tablets 320 mg daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Placebo Tablets daily for 12 weeks post two week titration phase.

Amantadine ER Tablets

Overall Number of Participants Analyzed 30 29 28
Mean (Standard Deviation)
Unit of Measure: score on a scale
Visit 2 (Baseline) Number Analyzed 26 participants 25 participants 19 participants
3.5  (2.02) 3.3  (2.63) 4.3  (2.59)
Visit 7 (Day 98)/Stable Dose LOCF [1] Number Analyzed 30 participants 27 participants 25 participants
4.1  (2.48) 2.8  (2.24) 3.8  (2.36)
Change from Baseline (SD) Number Analyzed 30 participants 27 participants 25 participants
0.8  (2.92) -0.5  (2.18) 0.1  (2.78)
Time Frame Three months
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 12 weeks post two week titration phase.

Amantadine ER Tablets

Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.

Amantadine ER Tablets

Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.

Placebo Tablets for Amantadine ER Tablets

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   1/30 (3.33%)      0/29 (0.00%)      0/28 (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   3/30 (10.00%)      1/29 (3.45%)      2/28 (7.14%)    
Blood and lymphatic system disorders       
syncope  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
traumatic haemothroax  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Cardiac disorders       
arrhythmia supraventricular  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Gastrointestinal disorders       
megacolon multi-organ failure  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders       
arthralgia osteonecrosis  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Psychiatric disorders       
impulse-control disorder  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
1
Term from vocabulary, MedDRA Version 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   20/30 (66.67%)      24/29 (82.76%)      15/28 (53.57%)    
Blood and lymphatic system disorders       
Anaemia  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Cardiac disorders       
Angina pectoris  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Arrhythmia supraventricular  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Extrasystoles  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Eye disorders       
Cataract  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Diplopia  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Dry Eye  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Vision Blurred  1  1/30 (3.33%)  1 1/29 (3.45%)  1 0/28 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain upper  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Constipation  1  1/30 (3.33%)  1 2/29 (6.90%)  2 0/28 (0.00%)  0
Diarrhea  1  0/30 (0.00%)  0 1/29 (3.45%)  1 1/28 (3.57%)  1
Dry Mouth  1  1/30 (3.33%)  1 3/29 (10.34%)  3 0/28 (0.00%)  0
Megacolon  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Nausea  1  0/30 (0.00%)  0 1/29 (3.45%)  1 2/28 (7.14%)  2
Oral Pain  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Toothache  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Vomiting  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
General disorders       
Asthenia  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Fatigue  1  1/30 (3.33%)  1 1/29 (3.45%)  1 1/28 (3.57%)  1
Gait disturbance  1  1/30 (3.33%)  1 0/29 (0.00%)  0 1/28 (3.57%)  1
General physical health deterioration  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Multi-organ failure  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Oedema  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Oedema peripheral  1  2/30 (6.67%)  2 4/29 (13.79%)  4 0/28 (0.00%)  0
Peripheral swelling  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations       
Ear infection  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Nasopharyngitis  1  1/30 (3.33%)  1 4/29 (13.79%)  4 0/28 (0.00%)  0
Onychomycosis  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Orchitis  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Skin infection  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Stoma site infection  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Urinary tract infection  1  2/30 (6.67%)  2 1/29 (3.45%)  1 2/28 (7.14%)  2
Viral infection  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  1/30 (3.33%)  1 1/29 (3.45%)  1 1/28 (3.57%)  1
Procedural pain  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Rib fracture  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Traumatic haemothorax  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Investigations       
Bacterial test positive  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Blood cholesterol increased  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Blood glucose increased  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Blood pressure orthostatic  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Haemoglobin urine present  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Neutrophil count increased  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Oxygen saturation decreased  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Protein urine present  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Urine ketone body present  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Urine leukocyte esterase positive  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Weight decreased  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
White blood cell count increased  1  1/30 (3.33%)  1 0/29 (0.00%)  0 1/28 (3.57%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/30 (3.33%)  1 2/29 (6.90%)  2 0/28 (0.00%)  0
back pain  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Mobility decreased  1  1/30 (3.33%)  1 0/29 (0.00%)  0 1/28 (3.57%)  1
Muscle rigidity  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Muscle spasms  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Muscular weakness  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Musculoskeletal stiffness  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Neck pain  1  1/30 (3.33%)  1 1/29 (3.45%)  1 0/28 (0.00%)  0
Osteoarthritis  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Osteonecrosis  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Pain in extremity  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Tendonitis  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder neoplasm  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Nervous system disorders       
Akinesia  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Balance disorder  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Carpal tunnel syndorme  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Cognitive disorder  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Dizziness  1  1/30 (3.33%)  1 3/29 (10.34%)  3 0/28 (0.00%)  0
Dyskinesia  1  3/30 (10.00%)  3 1/29 (3.45%)  1 3/28 (10.71%)  3
Dystonia  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Freezing phenomenon  1  1/30 (3.33%)  1 1/29 (3.45%)  1 0/28 (0.00%)  0
Headache  1  2/30 (6.67%)  2 0/29 (0.00%)  0 2/28 (7.14%)  2
Hypoaesthesia  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
On and off phenomenon  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Sciatica  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Somnolence  1  2/30 (6.67%)  2 0/29 (0.00%)  0 2/28 (7.14%)  2
Syncope  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Tension headache  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Tremor  1  1/30 (3.33%)  1 1/29 (3.45%)  1 0/28 (0.00%)  0
Psychiatric disorders       
Abnormal dreams  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Anxiety  1  0/30 (0.00%)  0 2/29 (6.90%)  2 0/28 (0.00%)  0
Confusional state  1  2/30 (6.67%)  2 1/29 (3.45%)  1 0/28 (0.00%)  0
Depressed mood  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Depression  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Hallucination  1  0/30 (0.00%)  0 4/29 (13.79%)  4 1/28 (3.57%)  1
Hallucination, auditory  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Hallucination, visual  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Hypersexuality  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Illusion  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Impulse-control disorder  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Insomnia  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Nightmare  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Obsessive-compulsive disorder  1  2/30 (6.67%)  2 0/29 (0.00%)  0 0/28 (0.00%)  0
Restlessness  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Sleep attacks  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Renal and urinary disorders       
Dysuria  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Pollakiuria  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Renal Failure  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Urinary retention  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Reproductive system and breast disorders       
Prostatism  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Prostatomegaly  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Dyspnoea exertional  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Pulmonary Mass  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Erythema  1  0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0
Nail dystrophy  1  0/30 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1
Social circumstances       
Gambling  1  1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0
Vascular disorders       
Hypertension  1  1/30 (3.33%)  1 3/29 (10.34%)  3 0/28 (0.00%)  0
Hypotension  1  2/30 (6.67%)  2 0/29 (0.00%)  0 1/28 (3.57%)  1
Orthostatic hypotension  1  0/30 (0.00%)  0 2/29 (6.90%)  2 2/28 (7.14%)  2
1
Term from vocabulary, MedDRA Version 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
Name/Title: George Wagner, VP of Regulatory Affairs
Organization: Osmotica Pharmaceuticals
Phone: 908-809-1357
Responsible Party: Osmotica Pharmaceutical US LLC
ClinicalTrials.gov Identifier: NCT02153645     History of Changes
Other Study ID Numbers: OS320-3005
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