Amantadine for Cerebral Palsy

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Amantadine, a medication that affects brain chemicals, might improve thinking skills in people with cerebral palsy (CP), a condition impacting movement and coordination. While most research on CP focuses on physical abilities, this study examines whether Amantadine can enhance cognitive functions. Individuals diagnosed with CP who are not experiencing unstable seizures or taking certain medications may qualify to participate. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

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 is the safety track record for Amantadine Hydrochloride?

Research has shown that Amantadine is generally safe. It is already approved for treating Parkinson's disease, indicating that its safety has been studied.

In past studies, many patients tolerated Amantadine well. Common side effects were mild, such as dizziness and dry mouth. Serious side effects, including mood changes or confusion, were rare and occurred in less than 3% of those who took the drug.

The kidneys process Amantadine, so individuals with kidney issues should exercise caution. Overall, many people have safely used the drug for various conditions. This should reassure participants about its safety for new uses, such as improving cognitive and motor function in cerebral palsy. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for cerebral palsy, which often focus on managing symptoms through physical therapy, surgery, or medications like muscle relaxants and antispasmodics, amantadine hydrochloride offers a novel approach. This drug is traditionally used as an antiviral and to treat Parkinson's disease, but researchers are excited about its potential for cerebral palsy because it targets both cognitive and motor impairments. Amantadine works by modulating neurotransmitters in the brain, which could enhance motor control and cognitive function, offering a dual benefit not commonly addressed by current treatments.

What evidence suggests that Amantadine might be an effective treatment for cerebral palsy?

Research shows that Amantadine, a drug often used for Parkinson's disease, can help improve movement issues like tremors. Although not typically used for cognitive problems in cerebral palsy (CP), it boosts dopamine effects in the brain, which might also aid thinking and memory. In people with Parkinson’s, Amantadine has increased 'good' ON time, reducing symptoms and improving quality of life. While direct evidence for its effects on CP is limited, this trial will explore how Amantadine might help with cognitive functions in CP, based on these promising findings. ^{6 7 8 9 10}

Who Is on the Research Team?

Heakyung Kim, MD

Principal Investigator

Columbia Irving Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosed with Cerebral Palsy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Amantadine Hydrochloride

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. gocovrihcp.com gocovrihcp.com/efficacy

Efficacy & Patient Diary Summary for Extended Release GOCOVRI® (amantadine) is clinically proven to treat dyskinesia while reducing OFF time in Parkinson's patients. Learn about efficacy, long-term results, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8571461/

Effects of Gocovri (Amantadine) Extended-Release ... Analyses suggest that Gocovri may specifically improve freezing, tremor, getting out of bed/car/deep chair, and eating tasks.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02153645

Efficacy and Safety of Amantadine Hydrochloride (HCl) ER ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/209410Orig1s000ClinPharmR.pdf

209410Orig1s000 - accessdata.fda.gov Results from Study OS320-PKP05 demonstrated that PK of amantadine from OSMOLEX™ ER tablets are dose proportional. Plasma amantadine exposure ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590112521000359

Potential utility of amantadine DR/ER in persons with ... Amantadine-DR/ER increased 'good' ON time in patients meeting 5-2-1 criteria. •. Increased good ON time resulted from reductions in troublesome dyskinesia and ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/208944lbl.pdf

GOCOVRI (amantadine) extended release capsules Of the 100 patients in the safety population described below, 39 patients were treated with GOCOVRI for 24 weeks. The safety data for these trials were pooled.

7. gocovrihcp.com gocovrihcp.com/safety

Safety Profile | GOCOVRI® (amantadine) Other clinically relevant adverse reactions observed at <3% included somnolence, fatigue, suicide ideation or attempt, apathy, delusions, illusions, and ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/amantadine-oral-route/description/drg-20061695

Amantadine (oral route) - Side effects & dosage Amantadine is an antidyskinetic medicine. It is used to treat Parkinson's disease (sometimes called paralysis agitans or shaking palsy) and its symptoms.

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499953/

Amantadine - StatPearls - NCBI Bookshelf - NIH The drug undergoes renal excretion, so the extended-release dosage form is contraindicated in patients with end-stage renal disease. Due to the possible ...

10. gocovri.com gocovri.com/

GOCOVRI® (amantadine) Extended Release Capsules ... GOCOVRI® (amantadine) helps treat dyskinesia and OFF time in people with Parkinson's disease. Learn about how GOCOVRI can help. See full safety information.