Trial Outcomes & Findings for Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID (NCT NCT02153632)
NCT ID: NCT02153632
Last Updated: 2022-02-16
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
Change from baseline to Day 98
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
240mg Amantadine HCl ER Tablets
Amantadine Hydrogen Chloride (HCl) ER Tablets 240mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
320mg Amantadine HCl ER Tablets
Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
Placebo Tablets for Amantadine
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
46
|
44
|
|
Overall Study
COMPLETED
|
27
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID
Baseline characteristics by cohort
| Measure |
240mg Amantadine HCl ER Tablets
n=45 Participants
Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
320mg Amantadine HCl ER Tablets
n=46 Participants
Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
Placebo Tablets for Amantadine
n=44 Participants
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.
Placebo
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 8.98 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 9.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Region of Enrollment
France
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to Day 98Population: Intent to treat population
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.
Outcome measures
| Measure |
240mg Amantadine HCl ER Tablets
n=45 Participants
Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
320mg Amantadine HCl ER Tablets
n=46 Participants
Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
Placebo Tablets for Amantadine
n=44 Participants
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.
Placebo
|
|---|---|---|---|
|
Unified Dyskinesia Rating Scale
Visit 2 (Baseline)
|
41.3 score on a scale
Standard Deviation 13.91
|
36.3 score on a scale
Standard Deviation 12.40
|
40.7 score on a scale
Standard Deviation 13.98
|
|
Unified Dyskinesia Rating Scale
Visit 7 (Day 98)/Stable Dose LOCF [1]
|
41.3 score on a scale
Standard Deviation 13.98
|
36.3 score on a scale
Standard Deviation 12.40
|
40.7 score on a scale
Standard Deviation 13.98
|
|
Unified Dyskinesia Rating Scale
Mean Change from Baseline (SD)
|
-15.2 score on a scale
Standard Deviation 15.58
|
-13.7 score on a scale
Standard Deviation 10.95
|
-9.0 score on a scale
Standard Deviation 10.62
|
SECONDARY outcome
Timeframe: Day 14 and Day 98 of treatmentPopulation: The number analyzed is the number of subjects with values at each time point.
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.
Outcome measures
| Measure |
240mg Amantadine HCl ER Tablets
n=45 Participants
Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
320mg Amantadine HCl ER Tablets
n=46 Participants
Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
Placebo Tablets for Amantadine
n=44 Participants
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.
Placebo
|
|---|---|---|---|
|
Mobility State Self-Assessment - Subject Diary Cards
Visit 2 (Baseline)
|
10.4 Hours
Standard Deviation 3.76
|
9.8 Hours
Standard Deviation 3.48
|
9.1 Hours
Standard Deviation 3.48
|
|
Mobility State Self-Assessment - Subject Diary Cards
Visit 7 (Day 98)/Stable Dose LOCF [1]
|
12.7 Hours
Standard Deviation 3.91
|
13.3 Hours
Standard Deviation 3.83
|
11.1 Hours
Standard Deviation 4.03
|
|
Mobility State Self-Assessment - Subject Diary Cards
Mean Change in Hours from Baseline (SD)
|
2.3 Hours
Standard Deviation 3.25
|
3.6 Hours
Standard Deviation 3.93
|
1.6 Hours
Standard Deviation 3.56
|
Adverse Events
240mg Amantadine HCl ER Tablets
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
320mg Amantadine HCl ER Tablets
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo Tablets for Amantadine
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
240mg Amantadine HCl ER Tablets
n=45 participants at risk
Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
320mg Amantadine HCl ER Tablets
n=46 participants at risk
Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
Placebo Tablets for Amantadine
n=44 participants at risk
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.
Placebo
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
constipation hemorrhoids
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
vestibular neuronitis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
cranial nerve palsies multiple
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Vascular disorders
hypertension
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
transient ischaemic attack
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Infections and infestations
brain abscess
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Metabolism and nutrition disorders
contipation diabetes mellitus inadequate control
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
thoracic vertebral fracture
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
Other adverse events
| Measure |
240mg Amantadine HCl ER Tablets
n=45 participants at risk
Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
320mg Amantadine HCl ER Tablets
n=46 participants at risk
Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.
Amantadine HCl ER (ALLAY-LID II)
|
Placebo Tablets for Amantadine
n=44 participants at risk
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.
Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Eye disorders
Vision Blurred
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
4.5%
2/44 • Number of events 2 • 26 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
8.9%
4/45 • Number of events 4 • 26 weeks
|
10.9%
5/46 • Number of events 5 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.3%
6/45 • Number of events 6 • 26 weeks
|
13.0%
6/46 • Number of events 6 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
General disorders
Asthenia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
General disorders
Fatigue
|
0.00%
0/45 • 26 weeks
|
6.5%
3/46 • Number of events 3 • 26 weeks
|
9.1%
4/44 • Number of events 4 • 26 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
General disorders
Malaise
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/45 • 26 weeks
|
8.7%
4/46 • Number of events 4 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
General disorders
Allergy to arthropod sting
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Acute sinusitis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Brain abscess
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/45 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Cystitis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Groin abscess
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Oral candidiasis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
4.5%
2/44 • Number of events 2 • 26 weeks
|
|
Infections and infestations
Tracheitis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
10.9%
5/46 • Number of events 5 • 26 weeks
|
6.8%
3/44 • Number of events 3 • 26 weeks
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
5/45 • Number of events 5 • 26 weeks
|
8.7%
4/46 • Number of events 4 • 26 weeks
|
11.4%
5/44 • Number of events 5 • 26 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
thoracic vertebral fracture
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
Bacterial test positive
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
Blood Chloesterol increased
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
Blood test abnormal
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Blood urea increased
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Blood urine present
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Creatinine renal clearance increased
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Crystal urine present
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
Electrocardiogram QT Shortened
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Electrocadiogram T wave abnormal
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
Hemoglobin urine present
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
6.5%
3/46 • Number of events 3 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Lymphocyte count decreased
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Mean cell hemoglobin concentration decreased
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Neutrophil count increased
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Red blood cells urine positive
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Urinary casts present
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Urine ketone body present
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Infections and infestations
Urine leukocyte esterase positive
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
Weight increased
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Investigations
White blood cells urine positive
|
0.00%
0/45 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Metabolism and nutrition disorders
Food Craving
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Metabolism and nutrition disorders
hypercholesterolaemia
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
6.5%
3/46 • Number of events 3 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular join syndrome
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Action tremor
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Akinesia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Amnesia
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Bradykinesia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.00%
0/45 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Dizziness postural
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Drooling
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Dysaesthesia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Dysarthria
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Dyskinesia
|
11.1%
5/45 • Number of events 5 • 26 weeks
|
6.5%
3/46 • Number of events 3 • 26 weeks
|
6.8%
3/44 • Number of events 3 • 26 weeks
|
|
Nervous system disorders
Dystonia
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Freezing phenomenon
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
headache
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
6.5%
3/46 • Number of events 3 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Hyperaesthesia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Parkinson's disease
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Somnolence
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
9.1%
4/44 • Number of events 4 • 26 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Anxiety
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
4.5%
2/44 • Number of events 2 • 26 weeks
|
|
Psychiatric disorders
Confusional state
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Depression
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
4.5%
2/44 • Number of events 2 • 26 weeks
|
|
Psychiatric disorders
Hallucination
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Hallucination, visual
|
6.7%
3/45 • Number of events 3 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Illusion
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Impulsive behaviour
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
4.5%
2/44 • Number of events 2 • 26 weeks
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Libido increased
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Nightmare
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Sleep attacks
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Renal and urinary disorders
Dysuria
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Renal and urinary disorders
Urine abnormality
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/45 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Vascular disorders
Haematoma
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
4.3%
2/46 • Number of events 2 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
4.4%
2/45 • Number of events 2 • 26 weeks
|
2.2%
1/46 • Number of events 1 • 26 weeks
|
4.5%
2/44 • Number of events 2 • 26 weeks
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/45 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
2.3%
1/44 • Number of events 1 • 26 weeks
|
|
Vascular disorders
Varicophebitis
|
2.2%
1/45 • Number of events 1 • 26 weeks
|
0.00%
0/46 • 26 weeks
|
0.00%
0/44 • 26 weeks
|
Additional Information
George Wagner, VP of Regulatory Affairs
Osmotica Pharmaceuticals
Phone: 9088091357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER