Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Cerebral palsy (CP) is a common childhood-onset disability associated with motor and cognitive impairments, however most research is focused on motor outcomes. The aim of this study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive function in adolescents and adults with CP.

Detailed Description
-----------------
CP is a heterogeneous condition due to injury to the developing brain. It is a condition that is often marked by both cognitive and motor disorders as well as increased prevalence of depression and anxiety. While most studies have focused on improving motor dysfunction, fewer have investigated cognitive impairments associated with CP. Dedicating a study to research the pharmacotherapeutic effect of Amantadine on cognitive function in adolescents and adults with cerebral palsy fills an important gap in development of a potential innovative treatment for cognitive deficits. The investigators hope to determine the effects of Amantadine on cognitive function in adolescents and adults with CP. The investigators will also evaluate secondary goals of improving gross and fine motor skills and mood.

Official Title
-----------------
Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: Amantadine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Cerebral Palsy Exclusion Criteria: Currently pregnant Unstable seizure condition Currently taking methadone Currently taking other dopamine agonists Currently taking anti-psychotic medication Previously taken amantadine Diagnosed with Chronic Kidney Disease (CKD)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amantadine<br>Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg) | Drug: Amantadine Hydrochloride<br>* 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.<br>* Other names: Gocovri;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Brief-A Score | 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. | Baseline | 
| Mean Brief-A Score | 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. | 3 weeks | 
| Mean Brief-A Score | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean PHQ-9 Score | 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. | Baseline | 
| Mean PHQ-9 Score | 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. | 3 weeks | 
| Mean PHQ-9 Score | 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. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fine motor skills, cerebral palsy, amantadine, cognitive function, gross motor skills, mood