Trial Outcomes & Findings for Altering Activation Patterns Post-stroke (NCT NCT02418949)
NCT ID: NCT02418949
Last Updated: 2023-10-23
Results Overview
GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
baseline and 9 weeks (immediately post intervention)
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
Cyproheptadine + AMP
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
26
|
25
|
|
Overall Study
COMPLETED
|
20
|
21
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Cyproheptadine + AMP
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Altering Activation Patterns Post-stroke
Baseline characteristics by cohort
| Measure |
Cyproheptadine + AMP
n=22 Participants
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
n=22 Participants
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
n=25 Participants
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
n=25 Participants
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
58.3 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Chedoke McMaster Scale of Hand
Equal or less than 2
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Chedoke McMaster Scale of Hand
Equal or Greater than 3
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Fugl-Meyer Upper Extremity Assessment
|
15 Score
STANDARD_DEVIATION 8.1 • n=5 Participants
|
12.9 Score
STANDARD_DEVIATION 5.5 • n=7 Participants
|
16.1 Score
STANDARD_DEVIATION 7.1 • n=5 Participants
|
15.6 Score
STANDARD_DEVIATION 5.6 • n=4 Participants
|
15 Score
STANDARD_DEVIATION 6.6 • n=21 Participants
|
|
Lesion Side
Left
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Lesion Side
Right
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Time Since Stroke onset (Years)
|
5.9 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
8.5 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
6.4 years
STANDARD_DEVIATION 6.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 9 weeks (immediately post intervention)GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.
Outcome measures
| Measure |
Cyproheptadine + AMP
n=20 Participants
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
n=21 Participants
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
n=23 Participants
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
n=24 Participants
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
|---|---|---|---|---|
|
Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
|
-3.66 Seconds
Interval -7.95 to 0.63
|
-0.51 Seconds
Interval -3.62 to 2.6
|
-4.00 Seconds
Interval -7.72 to -0.28
|
-3.89 Seconds
Interval -8.65 to 0.88
|
SECONDARY outcome
Timeframe: baseline and 9 weeks (immediately post intervention)Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.
Outcome measures
| Measure |
Cyproheptadine + AMP
n=20 Participants
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
n=21 Participants
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
n=23 Participants
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
n=24 Participants
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
|---|---|---|---|---|
|
Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)
|
-1.66 Seconds
Interval -2.79 to 0.54
|
-0.96 Seconds
Interval -3.2 to 1.28
|
-1.06 Seconds
Interval -3.19 to 1.07
|
-2.65 Seconds
Interval -4.7 to -0.59
|
Adverse Events
Cyproheptadine + AMP
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo for Cyproheptadine + Stretching
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Cyproheptadine + Stretching
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo for Cyproheptadine + AMP
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyproheptadine + AMP
n=23 participants at risk
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
n=22 participants at risk
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
n=26 participants at risk
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
n=25 participants at risk
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
|---|---|---|---|---|
|
Nervous system disorders
Convulsions
|
0.00%
0/23 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
4.5%
1/22 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/26 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/25 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Cardiac disorders
CHF Exacerbation
|
0.00%
0/23 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/22 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/25 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Gastrointestinal disorders
Bowel Obstruction
|
4.3%
1/23 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/22 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/26 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/25 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Cardiac disorders
Coronary Blockage
|
0.00%
0/23 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
4.5%
1/22 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/26 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/25 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/22 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/26 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/25 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Skin and subcutaneous tissue disorders
Foot Wound
|
4.3%
1/23 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/22 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/26 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
0.00%
0/25 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
Other adverse events
| Measure |
Cyproheptadine + AMP
n=23 participants at risk
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
Placebo for Cyproheptadine + Stretching
n=22 participants at risk
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Cyproheptadine + Stretching
n=26 participants at risk
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
|
Placebo for Cyproheptadine + AMP
n=25 participants at risk
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
|
|---|---|---|---|---|
|
General disorders
Dry Mouth
|
39.1%
9/23 • Number of events 9 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
40.9%
9/22 • Number of events 9 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
42.3%
11/26 • Number of events 11 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
36.0%
9/25 • Number of events 9 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
General disorders
Low Energy
|
43.5%
10/23 • Number of events 10 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
31.8%
7/22 • Number of events 7 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
46.2%
12/26 • Number of events 12 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
16.0%
4/25 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Metabolism and nutrition disorders
Weight Gain
|
30.4%
7/23 • Number of events 7 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
27.3%
6/22 • Number of events 6 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
34.6%
9/26 • Number of events 9 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
20.0%
5/25 • Number of events 5 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Psychiatric disorders
Low Motivation
|
4.3%
1/23 • Number of events 1 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
22.7%
5/22 • Number of events 5 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
34.6%
9/26 • Number of events 9 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
8.0%
2/25 • Number of events 2 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Gastrointestinal disorders
Constipation
|
26.1%
6/23 • Number of events 6 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
22.7%
5/22 • Number of events 5 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
23.1%
6/26 • Number of events 6 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
24.0%
6/25 • Number of events 6 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
General disorders
Restless/Jittery
|
17.4%
4/23 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
13.6%
3/22 • Number of events 3 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
15.4%
4/26 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
12.0%
3/25 • Number of events 3 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
General disorders
Slowness/Trouble getting moving
|
13.0%
3/23 • Number of events 3 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
27.3%
6/22 • Number of events 6 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
26.9%
7/26 • Number of events 7 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
20.0%
5/25 • Number of events 5 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Renal and urinary disorders
Frequent Urination
|
30.4%
7/23 • Number of events 7 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
27.3%
6/22 • Number of events 6 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
26.9%
7/26 • Number of events 7 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
16.0%
4/25 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
General disorders
Sleep Problems
|
13.0%
3/23 • Number of events 3 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
18.2%
4/22 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
19.2%
5/26 • Number of events 5 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
20.0%
5/25 • Number of events 5 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
Renal and urinary disorders
Difficulty Urinating
|
17.4%
4/23 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
9.1%
2/22 • Number of events 2 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
7.7%
2/26 • Number of events 2 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
8.0%
2/25 • Number of events 2 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
|
General disorders
Memory Problems
|
8.7%
2/23 • Number of events 2 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
36.4%
8/22 • Number of events 8 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
34.6%
9/26 • Number of events 9 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
16.0%
4/25 • Number of events 4 • Adverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place