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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline

Results posted on

2022-05-31

Participant Flow

Participant milestones

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.
Overall Study
STARTED
11
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
0

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

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.
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
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
11 Participants
n=99 Participants
Cerebral Palsy Diagnosis
11 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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

SECONDARY outcome

Timeframe: Baseline

Population: 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

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.
Mean PHQ-9 Score
4.667 score on a scale
Standard Deviation 4.397

SECONDARY outcome

Timeframe: 3 weeks

Population: 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

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 weeks

Population: 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

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 events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

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.
General disorders
Seizure event
9.1%
1/11 • Number of events 1 • Baseline to 6 weeks

Other adverse events

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.
Musculoskeletal and connective tissue disorders
Increased Muscle Ridigity (Muscle tone)
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

Phone: 212-305-9416

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place