Trial Outcomes & Findings for Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145) (NCT NCT00693472)
NCT ID: NCT00693472
Last Updated: 2018-11-07
Results Overview
Incidence of akathisia is reported as the number of participants who experienced akathisia. Akathisia is defined as a score of 3 on the Barnes akathisia scale (BAS) for 3 consecutive intervals or an akathisia score (BAS) of ≥4 for any single day, or the use of a rescue medication within 13 days of initiating treatment with haloperidol and preladenant. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).
TERMINATED
PHASE2
46 participants
Up to 13 days
2018-11-07
Participant Flow
Participant milestones
| Measure |
Part 1: Preladenant
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
Placebo every 12 hours for 13 days
|
Part 2: Preladenant
Preladenant 25 mg every 12 hours for 13 days
|
Part 2: Standard of Care
Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
|
|---|---|---|---|---|
|
Part 1
STARTED
|
19
|
13
|
0
|
0
|
|
Part 1
COMPLETED
|
13
|
9
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
6
|
4
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
8
|
6
|
|
Part 2
COMPLETED
|
0
|
0
|
6
|
4
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Part 1: Preladenant
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
Placebo every 12 hours for 13 days
|
Part 2: Preladenant
Preladenant 25 mg every 12 hours for 13 days
|
Part 2: Standard of Care
Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
|
|---|---|---|---|---|
|
Part 1
Adverse Event
|
1
|
1
|
0
|
0
|
|
Part 1
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Part 1
Withdrew - reason unrelated to treatment
|
5
|
2
|
0
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
1
|
0
|
|
Part 2
Withdrew - reason unrelated to treatment
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)
Baseline characteristics by cohort
| Measure |
Part 1: Preladenant
n=19 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=13 Participants
Placebo every 12 hours for 13 days
|
Part 2: Preladenant
n=8 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 2: Standard of Care
n=6 Participants
Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Between 18 and <65 years
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 13 daysPopulation: Efficacy analysis population was defined as participants who received at least one dose of study drug.
Incidence of akathisia is reported as the number of participants who experienced akathisia. Akathisia is defined as a score of 3 on the Barnes akathisia scale (BAS) for 3 consecutive intervals or an akathisia score (BAS) of ≥4 for any single day, or the use of a rescue medication within 13 days of initiating treatment with haloperidol and preladenant. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).
Outcome measures
| Measure |
Part 1: Preladenant
n=19 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=13 Participants
Placebo every 12 hours for 13 days
|
|---|---|---|
|
Part 1: Number of Participants With Akathisia
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: Efficacy analysis population was defined as participants who received at least one dose of study drug.
Incidence of treatment failure is reported as the number of participants who were treatment failures. A treatment failure is defined as the failure to achieve at least a 1 point reduction from baseline in BAS score at 24 to 26 hours following study treatment. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).
Outcome measures
| Measure |
Part 1: Preladenant
n=8 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=6 Participants
Placebo every 12 hours for 13 days
|
|---|---|---|
|
Part 2: Number of Participants Who Were Treatment Failures
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14 of Part 1Population: Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.
Global clinical impression (GCI) was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).
Outcome measures
| Measure |
Part 1: Preladenant
n=13 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=9 Participants
Placebo every 12 hours for 13 days
|
|---|---|---|
|
Part 1: Mean Global Clinical Impression at Day 14
|
0.9231 Score on a scale
Standard Deviation 0.7596
|
1.7778 Score on a scale
Standard Deviation 0.4410
|
SECONDARY outcome
Timeframe: Day 14 of Part 1Population: Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).
Outcome measures
| Measure |
Part 1: Preladenant
n=13 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=9 Participants
Placebo every 12 hours for 13 days
|
|---|---|---|
|
Part 1: Mean Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score at Day 14
|
38.4615 Score on a scale
Standard Deviation 19.4834
|
36.3333 Score on a scale
Standard Deviation 17.0587
|
SECONDARY outcome
Timeframe: Day 14 of Part 2Population: Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.
The GCI was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).
Outcome measures
| Measure |
Part 1: Preladenant
n=6 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=4 Participants
Placebo every 12 hours for 13 days
|
|---|---|---|
|
Part 2: Mean GCI at Day 14
|
0.6667 Score on a scale
Standard Deviation 1.0328
|
2.0000 Score on a scale
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Day 14 of Part 2Population: Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).
Outcome measures
| Measure |
Part 1: Preladenant
n=6 Participants
Preladenant 25 mg every 12 hours for 13 days
|
Part 1: Placebo
n=4 Participants
Placebo every 12 hours for 13 days
|
|---|---|---|
|
Part 2: PANSS Total Score at Day 14
|
43.5000 Score on a scale
Standard Deviation 28.5430
|
27.75 Score on a scale
Standard Deviation 11.2361
|
Adverse Events
Part 1: Placebo
Part 1: Preladenant
Part 2: Standard of Care
Part 2: Preladenant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Placebo
n=13 participants at risk
Placebo every 12 hours for 13 days
|
Part 1: Preladenant
n=19 participants at risk
Preladenant 25 mg every 12 hours for 13 days
|
Part 2: Standard of Care
n=6 participants at risk
Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
|
Part 2: Preladenant
n=8 participants at risk
Preladenant 25 mg every 12 hours for 13 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.7%
1/13 • Number of events 2 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
General disorders
FATIGUE
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
General disorders
MALAISE
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Infections and infestations
ABSCESS ORAL
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Infections and infestations
RHINITIS
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 2 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
AKATHISIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
COGWHEEL RIGIDITY
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
15.8%
3/19 • Number of events 4 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
DYSKINESIA
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
15.4%
2/13 • Number of events 3 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
25.0%
2/8 • Number of events 3 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
HEAD TITUBATION
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
HEADACHE
|
7.7%
1/13 • Number of events 2 • Up to 22 days (including follow-up)
|
15.8%
3/19 • Number of events 3 • Up to 22 days (including follow-up)
|
33.3%
2/6 • Number of events 3 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
HYPERTONIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
OROMANDIBULAR DYSTONIA
|
7.7%
1/13 • Number of events 1 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
10.5%
2/19 • Number of events 2 • Up to 22 days (including follow-up)
|
33.3%
2/6 • Number of events 2 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 2 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Nervous system disorders
TREMOR
|
23.1%
3/13 • Number of events 3 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 2 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 1 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 2 • Up to 22 days (including follow-up)
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
16.7%
1/6 • Number of events 2 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
|
Psychiatric disorders
PARANOIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
0.00%
0/19 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
12.5%
1/8 • Number of events 1 • Up to 22 days (including follow-up)
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/13 • Up to 22 days (including follow-up)
|
5.3%
1/19 • Number of events 1 • Up to 22 days (including follow-up)
|
0.00%
0/6 • Up to 22 days (including follow-up)
|
0.00%
0/8 • Up to 22 days (including follow-up)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the Sponsor. The investigator further agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
- Publication restrictions are in place
Restriction type: OTHER