Cerebral PalsyPhase 4NCT04273737
Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy
A Phase 4 study testing Amantadine Hydrochloride in people with Cerebral Palsy, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Amantadine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 22 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with Cerebral Palsy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Amantadine Hydrochloride
- Keywords
- cerebral palsy, amantadine, cognitive function, gross motor skills, fine motor skills, mood
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine HydrochlorideDrug
Also called Symmetrel, Symadine, Osmolex ER, Gocovri
6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
| Study group | Role | What they receive |
|---|---|---|
| Amantadine | Experimental | Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg) Receives: Drug: Amantadine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start28 Feb 2020
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Why it stopped: PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heakyung Kim, MD, Principal investigator, Columbia Irving Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273737
- Sponsor's protocol ID
- AAAS1907
- Status last verified
- May 2022
- First submitted
- 14 Feb 2020
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04273737
- Acronym / sponsor ID
- AAAS1907
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, amantadine, cognitive function, gross motor skills, fine motor skills, mood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amantadine | Experimental | Drug: Amantadine HydrochlorideDaily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with Cerebral Palsy
Key exclusion criteria (7 listed)
- Currently pregnant
- Unstable seizure condition
- Currently taking methadone
- Currently taking other dopamine agonists
- Currently taking anti-psychotic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amantadine HydrochlorideAlso: Symmetrel, Symadine, Osmolex ER, Gocovri6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary. | Drug | Amantadine |
Primary outcome
Mean Brief-A Score
Time frame: 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.
Mean Brief-A Score
Time frame: 3 weeks
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.
Mean Brief-A Score
Time frame: 6 weeks
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 secondary outcomes
Mean PHQ-9 Score
Time frame: Baseline
Mean PHQ-9 Score
Time frame: 3 weeks
Mean PHQ-9 Score
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heakyung Kim, MD principal investigator
Columbia Irving Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amantadine Hydrochloride in people with Cerebral Palsy, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Brief-A Score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.