Trial Outcomes & Findings for Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy (NCT NCT04273737)
NCT ID: NCT04273737
Last Updated: 2022-05-31
Results Overview
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
TERMINATED
PHASE4
11 participants
Baseline
2022-05-31
Participant Flow
Participant milestones
| Measure |
Amantadine
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Amantadine
n=11 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
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|---|---|
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Age, Customized
Ages
|
24.8 years
STANDARD_DEVIATION 8.30 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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11 Participants
n=99 Participants
|
|
Cerebral Palsy Diagnosis
|
11 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Only includes collected data from participants who completed the BRIEF-A at baseline.
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
Outcome measures
| Measure |
Amantadine
n=7 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
|
Mean Brief-A Score
|
57.4285 T-score
Standard Deviation 8.050
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Only includes the collected data from participants who completed the BRIEF-A at the 3-week visit.
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
Outcome measures
| Measure |
Amantadine
n=5 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
|
Mean Brief-A Score
|
55.2 T-score
Standard Deviation 9.431
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Only includes the collected data from participants who completed the BRIEF-A at the 6-week visit.
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
Outcome measures
| Measure |
Amantadine
n=5 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
|
Mean Brief-A Score
|
60.2 T-score
Standard Deviation 10.979
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SECONDARY outcome
Timeframe: BaselinePopulation: Only includes the collected data from participants who completed the PH-9 at the baseline visit.
The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
Outcome measures
| Measure |
Amantadine
n=9 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
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Mean PHQ-9 Score
|
4.667 score on a scale
Standard Deviation 4.397
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SECONDARY outcome
Timeframe: 3 weeksPopulation: Only includes the collected data from participants who completed the PH-9 at the 3-week visit.
The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
Outcome measures
| Measure |
Amantadine
n=7 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
|
Mean PHQ-9 Score
|
3.14 score on a scale
Standard Deviation 1.726
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only includes the collected data from participants who completed the PH-9 at the 6-week visit.
The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
Outcome measures
| Measure |
Amantadine
n=7 Participants
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
|
Mean PHQ-9 Score
|
6.429 score on a scale
Standard Deviation 5.473
|
Adverse Events
Amantadine
Serious adverse events
| Measure |
Amantadine
n=11 participants at risk
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
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|---|---|
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General disorders
Seizure event
|
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
Other adverse events
| Measure |
Amantadine
n=11 participants at risk
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
|
|---|---|
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Musculoskeletal and connective tissue disorders
Increased Muscle Ridigity (Muscle tone)
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9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
|
Gastrointestinal disorders
Possible Urinary retention, dizziness, dullness
|
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Right Hip pain for 3 days (with collapse due to pain)
|
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
|
Nervous system disorders
Mania
|
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
|
Infections and infestations
urinary Tract Inflection
|
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks
|
Additional Information
Dr. Heakyung Kim
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place