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

Recruiting at 1 trial location

Overseen By Nancy Lee, MS

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Columbia University

Must not be taking: Methadone, Dopamine agonists, Antipsychotics

Disqualifiers: Pregnancy, Unstable seizures, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. Specifically, you cannot participate if you are currently taking methadone, other dopamine agonists, or anti-psychotic medications.

What evidence supports the effectiveness of the drug Amantadine Hydrochloride?

Amantadine Hydrochloride has shown effectiveness in improving symptoms in patients with Parkinson's disease, especially when combined with other medications like levodopa and carbidopa, leading to significant improvements in symptom and activity scores. It has also been effective in treating Friedreich's ataxia, with patients showing notable improvement in disability scores. ^{1 2 3 4 5}

How does the drug Amantadine Hydrochloride differ from other treatments?

Amantadine Hydrochloride is unique because it not only treats influenza A by inhibiting virus replication but also helps improve symptoms in Parkinson's disease, especially in cases resistant to other medications like levodopa. Its dual action as an antiviral and antiparkinson agent makes it distinct from other treatments. ^{1 2 3 6 7}

Research Team

Heakyung Kim, MD

Principal Investigator

Columbia Irving Medical Center

Eligibility Criteria

Inclusion Criteria

Diagnosed with Cerebral Palsy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily regimen of amantadine hydrochloride tablets for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Amantadine Hydrochloride

Participant Groups

Group I: Amantadine Experimental Treatment 1 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)

Amantadine Hydrochloride is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gocovri for:

• Dyskinesia associated with Parkinson's disease
• Influenza A viral infection

Approved in European Union as Symmetrel for:

• Parkinson's disease
• Extrapyramidal side effects of medications
• Postherpetic neuralgia

Approved in Canada as Amantadine Hydrochloride for:

• Parkinson's disease
• Influenza A viral infection

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Findings from Research

A 65-year-old woman with Parkinsonism who did not respond to standard treatments like levodopa and bromocriptine showed significant improvement in motor and mental function after being treated with amantadine (200 mg/day).

This case highlights amantadine's potential as an effective alternative therapy for patients with Parkinsonism who are resistant to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amantadine for levodopa resistant parkinsonism. Sandyk, R., Iacono, RP., Snider, SR.[2019]

Amantadine hydrochloride, at doses of 2.5 and 5 mg/kg, significantly reduced the stimulating effects of d-amphetamine on motor activity in mice, indicating its potential to modulate CNS stimulation.

Additionally, amantadine increased the anorexic effects of d-amphetamine, as shown by reduced milk intake, suggesting it may influence appetite regulation in the context of stimulant use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amantadine decreases d-amphetamine stimulation and increases d-amphetamine anorexia in mice. Clark, R., Smith, DH., Vernier, VG., et al.[2020]

In a study of 42 patients with Parkinson's disease, amantadine significantly improved symptoms and activity impairment scores by 92% and 95% respectively, compared to only 4% and 18% improvements with placebo, demonstrating its efficacy when combined with levodopa and carbidopa.

The side effects of amantadine were generally similar to those of placebo, with only a few mild cases reported, indicating that it is a safe addition to existing Parkinson's treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amantadine and a fixed combination of levodopa and carbidopa in the treatment of Parkinson's disease. Savery, F.[2013]

A new HPLC method was developed to simultaneously detect amantadine and four related compounds with very low detection limits, making it effective for analyzing these drugs in solution.

The study also revealed that ADAMA, rimantadine, and memantine bind to human alpha(1)-acid glycoprotein with varying affinities, which could influence their therapeutic effects and interactions in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous liquid chromatographic assay of amantadine and its four related compounds in phosphate-buffered saline using 4-fluoro-7-nitro-2,1,3-benzoxadiazole as a fluorescent derivatization reagent. Higashi, Y., Nakamura, S., Matsumura, H., et al.[2015]

A new LC-MS/MS method for analyzing amantadine in serum simplifies the process by eliminating the need for laborious sample pretreatment steps like extraction and derivatization, making it more efficient.

This method demonstrated high specificity and accuracy, with a detection limit of 20 mg/l and a recovery rate of 99-101%, showing it is comparable to traditional gas chromatography without significant bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of serum amantadine by liquid chromatography-tandem mass spectrometry. Arndt, T., Guessregen, B., Hohl, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Amantadine for levodopa resistant parkinsonism. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Amantadine decreases d-amphetamine stimulation and increases d-amphetamine anorexia in mice. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Current status of amantadine and rimantadine as anti-influenza-A agents: memorandum from a WHO meeting. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The treatment of Friedreich's ataxia with amantadine hydrochloride. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Amantadine and a fixed combination of levodopa and carbidopa in the treatment of Parkinson's disease. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Simultaneous liquid chromatographic assay of amantadine and its four related compounds in phosphate-buffered saline using 4-fluoro-7-nitro-2,1,3-benzoxadiazole as a fluorescent derivatization reagent. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Determination of serum amantadine by liquid chromatography-tandem mass spectrometry. [2019]