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Dopaminergic Agonist

Amantadine for Cerebral Palsy

Phase 4
Waitlist Available
Led By Heakyung Kim, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Diagnosed with Cerebral Palsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing Amantadine, a medication that helps improve brain function, on adolescents and adults with cerebral palsy. The goal is to see if it can enhance their thinking abilities. Researchers will also check if it helps with movement and mood. Amantadine has been studied for its effectiveness in treating traumatic brain injury and ADHD in children, showing positive results in improving alertness, arousal, and cognitive functions.

Eligible Conditions
  • Cerebral Palsy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Brief-A Score
Secondary study objectives
Mean PHQ-9 Score

Side effects data

From 2010 Phase 2 & 3 trial • 184 Patients • NCT00970944
21%
Hypertonia / Spasticity
15%
Urinary tract infection
14%
Insomnia / Sleep Disturbance
14%
Agitation / Aggression
11%
Infections
10%
General Medical Problems
7%
Pneumonia
3%
Hydrocephalus
3%
Infection
2%
Other Gastrointestinal Problems
1%
Cardiac arrest
1%
Other Neurologic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amantadine HCL
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AmantadineExperimental Treatment1 Intervention
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amantadine Hydrochloride
2009
Completed Phase 3
~360

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,169 Total Patients Enrolled
5 Trials studying Cerebral Palsy
1,110 Patients Enrolled for Cerebral Palsy
Heakyung Kim, MD5.06 ReviewsPrincipal Investigator - Columbia Irving Medical Center
Columbia University
2 Previous Clinical Trials
18 Total Patients Enrolled
2 Trials studying Cerebral Palsy
18 Patients Enrolled for Cerebral Palsy
5Patient Review
Dr. Kim was both compassionate and comprehensive in their care.
~2 spots leftby Nov 2025
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