Trial Outcomes & Findings for Buspirone Therapy for Localized Epilepsy (NCT NCT01496612)
NCT ID: NCT01496612
Last Updated: 2021-10-05
Results Overview
Participants utilized a seizure calendar to record the number of seizures that occurred during the three month treatment period, i.e., while participants were either taking Buspirone or Placebo. Seizure frequency was calculated as the total number of seizures occurring during each three month period. For each period a mean was calculated across subjects.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Three months
Results posted on
2021-10-05
Participant Flow
Participants were recruited from referrals to the NINDS Clinical Epilepsy Section. In addition, self-referral was permitted.
Nine participants were consented to the protocol. Two participants decided not to participate prior to baseline and randomization.
Participant milestones
| Measure |
Buspirone Then Placebo
Participants were administered Buspirone, followed by a washout period, and then administered Placebo
|
Placebo Then Buspirone
Participants were administered Placebo, followed by a washout period, and then administered Buspirone
|
|---|---|---|
|
1st Intervention
STARTED
|
3
|
4
|
|
1st Intervention
COMPLETED
|
1
|
4
|
|
1st Intervention
NOT COMPLETED
|
2
|
0
|
|
2nd Intervention
STARTED
|
1
|
4
|
|
2nd Intervention
COMPLETED
|
1
|
4
|
|
2nd Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Buspirone Then Placebo
Participants were administered Buspirone, followed by a washout period, and then administered Placebo
|
Placebo Then Buspirone
Participants were administered Placebo, followed by a washout period, and then administered Buspirone
|
|---|---|---|
|
1st Intervention
Adverse Event
|
1
|
0
|
|
1st Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Buspirone Therapy for Localized Epilepsy
Baseline characteristics by cohort
| Measure |
All Participants
n=7 Participants
All participants enrolled in the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three monthsParticipants utilized a seizure calendar to record the number of seizures that occurred during the three month treatment period, i.e., while participants were either taking Buspirone or Placebo. Seizure frequency was calculated as the total number of seizures occurring during each three month period. For each period a mean was calculated across subjects.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=5 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Seizure Frequency in the Buspirone (Active) and Placebo Periods
|
33.2 number of seizures
Standard Deviation 25.51
|
31.2 number of seizures
Standard Deviation 32.57
|
SECONDARY outcome
Timeframe: Three monthsPopulation: One participant in the Placebo group did not complete the HAM-A scale.
Participants were administered the Hamilton Anxiety Rating Scale (HAM-A) at the end of each three month treatment period, i.e., while participants were either on Buspirone or Placebo. The HAM-A measures an individual's severity of anxiety symptoms. The scale consists of 14 parameters, each defined by a series of symptoms. Each group of symptoms is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild anxiety, 18-24 mild to moderate anxiety and 25-30 moderate to severe anxiety.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=4 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Mean Score on the Hamilton Anxiety Rating Scale (HAM-A) at the End of the Active and Placebo Periods.
|
.80 score on a scale
Standard Deviation .45
|
2 score on a scale
Standard Deviation .82
|
SECONDARY outcome
Timeframe: Three monthsThe Hamilton Depression Rating Scale (HAM-D) was administered to participants at the end of each treatment period. The HAM-D is a multiple item questionnaire used to provide an indication of depression. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Although the HAM-D form lists 21 items, the scoring is based on the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2 with 0 = absent and 2 = frequent or severe. Scores range from 0 to 50 with a score of 0-7 representing normal and a score \>/= 23 representing very severe depression.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=5 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Mean Score on the Hamilton Depression Rating Scale (HAM-D) at the End of the Active and Placebo Periods
|
1.40 score on a scale
Standard Deviation 1.14
|
2.40 score on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Three monthsThe Beck Depression Inventory (BDI) is a 21-item test presented in multiple-choice format, which measures presence and degree of depression in adolescents and adults. The BDI evaluates 21 symptoms of depression. The 21 items cover sadness, pessimism, past failure, self-dislike, self-criticism, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, difficulty concentrating, tiredness or fatigue, and loss of interest in sex. Each answer is scored on a scale value of 0-3 with 0 indicating absence of symptom and a 3 indicating severe symptom. The total range of possible scores is 0-63. A total score of \<10 indicates no or minimal depression,10-18 indicates mild-to-moderate depression,19-29 indicates moderate-to-severe depression, and 30+ indicates severe depression.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=5 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Mean Score on the Beck Depression Inventory (BDI) at the End of the Active and Placebo Periods
|
.80 score on a scale
Standard Deviation .84
|
1.8 score on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Three monthsThe WAIS-IV Cancellation Subtest assesses processing speed and attention. It is a timed test with two sequential forms, A \& B. Each form requires the participant to scan an array of colored shapes (e.g., triangle, circle) randomly arranged. The participant is given 45 seconds to mark (i.e. cross out) as many of the two designated geometric shapes in the total array as possible. Cancellation scores are based on the number of correct responses minus the number of incorrect responses completed in the allotted time. The total correct for the two forms is converted to a single scaled score based on age-corrected normative data with a mean of 10 +/- 3 and a range of 1 to 19. The mean is 10 +/-3; thus a typical age corrected score is between 8 and 11; the higher the number the better the score. A low score (\<8) is progressively more impaired, the lower the score. A high score (\>12) indicates more efficiency and better attention than compared to others the same age.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=5 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Mean Score on the Cancellation Task Following 3 Months on Active Drug and 3 Months on Placebo
|
7.6 score on a scale
Standard Deviation 1.67
|
9.8 score on a scale
Standard Deviation .84
|
SECONDARY outcome
Timeframe: Three monthsThe Trail Making Test-A (TMT-A) measures visual scanning and rote memory. The participant is asked to draw a line between 24 consecutive numbered circles randomly arranged on a page. The TMT-A is scored by how long it takes to complete the test. An average score for TMT-A is 29 seconds and a deficient score is \>78 seconds.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=5 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Mean Score on the Trail Making Test-A (TMT-A) Following 3 Months on Active Drug and 3 Months on Placebo
|
47 Seconds
Standard Deviation 4.36
|
43.8 Seconds
Standard Deviation 12.87
|
SECONDARY outcome
Timeframe: Three monthsThe Trail Making Test-B (TMT-B) measures visual scanning and executive functioning. The participant is asked to draw a line between 24 consecutive numbered and lettered circles randomly arranged on a page. The participant is required to switch between numbers and letters in consecutive order. The TMT-B is scored by how long it takes to complete the test. An average score for TMT-B is 75 seconds and a deficient score is \>273 seconds.
Outcome measures
| Measure |
Buspirone
n=5 Participants
Participants with epilepsy receiving Buspirone
|
Placebo
n=5 Participants
Participants with epilepsy receiving Placebo
|
|---|---|---|
|
Mean Score on the Trail Making Test-B (TMT-B) Following 3 Months on Active Drug and 3 Months on Placebo
|
43.4 Seconds
Standard Deviation 9.74
|
46 Seconds
Standard Deviation 4.36
|
Adverse Events
Buspirone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Washout Period Following Buspirone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Washout Period Following Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buspirone
n=7 participants at risk
Events occurring while participants on Buspirone x3 months
|
Washout Period Following Buspirone
n=7 participants at risk
Events occurring during the washout period following 3 months of Buspirone
|
Placebo
n=5 participants at risk
Events occurring while participants were taking Placebo x3 months
|
Washout Period Following Placebo
n=5 participants at risk
Events occurring during the washout period following 3 months of Placebo
|
|---|---|---|---|---|
|
Nervous system disorders
Confusion
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Gastrointestinal disorders
Nausea with/without vomitting
|
14.3%
1/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Sleepy
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 3 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 3 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
40.0%
2/5 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
40.0%
2/5 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Poor Memory
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Fall with seizure
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Psychiatric disorders
Labile
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
14.3%
1/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Cardiac disorders
Chest pain
|
14.3%
1/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Dizziness
|
42.9%
3/7 • Number of events 6 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Lightheaded
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 4 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Reproductive system and breast disorders
Endometriosis
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Poor balance
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Number of events 2 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Throat swelling
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Infections and infestations
Sore throat
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Skin and subcutaneous tissue disorders
Skin burn
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Psychiatric disorders
Combative
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Eye disorders
Itchy eyes
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
20.0%
1/5 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Nervous system disorders
Dysphasia
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Psychiatric disorders
Vivid dreams
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/7 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
0.00%
0/5 • Intervention 1 was 3 months, followed by a two week titration and 2 week Washout period. Intervention 2 was 3 months, followed by a two week titration and 1 day washout period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place