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

NCT04273737 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: AAAS1907
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; amantadine; cognitive function; gross motor skills; fine motor skills; mood

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Mean PHQ-9 Score

  Baseline

• Mean PHQ-9 Score

  3 weeks

• Mean PHQ-9 Score

  6 weeks

Study Arms (1)

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)

Drug: Amantadine Hydrochloride

Interventions

Amantadine Hydrochloride DRUG

6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.

Also known as: Symmetrel, Symadine, Osmolex ER, Gocovri

Amantadine

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Cerebral Palsy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Heakyung Kim
• Organization: Columbia University Irving Medical Center

hk2641@cumc.columbia.edu

212-305-9416

Study Officials

• Heakyung Kim, MD

  Columbia Irving Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: February 28, 2020
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Locations

US (1)