Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy
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| ClinicalTrials.gov Identifier: NCT04273737 |
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Recruitment Status :
Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Drug: Amantadine Hydrochloride | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy |
| Estimated Study Start Date : | March 2020 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Amantadine
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
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Drug: Amantadine Hydrochloride
6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
Other Names:
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- Change in Oral Symbol-Digit Modalities Test Score [ Time Frame: Baseline and 6 weeks ]
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than 5 minutes. This simple, economical test is an ideal way for busy clinicians to screen for organic cerebral dysfunction in both children (8 years and older) and adults.The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. A lower score indicates greater cognitive impairment (worse outcome).
Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
- Change in Stroop Test Score [ Time Frame: Baseline and 6 weeks ]
The Stroop Color and Word Test (SCWT) is a neuropsychological test. It assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Subjects are required to read three different tables as fast as possible in 45 seconds. For the first two, participants are required to read names of colors printed in black ink (W) and name different color patches (C). In the third, color-words (CW) are printed in an inconsistent color ink (for instance the word "red" is printed in green ink). Participants are required to name the color of the ink instead of reading the word.
Interference score (IG) = CW - [(W × C)/(W + C)]
A greater IG score indicates a higher ability to inhibit cognitive interference (better outcome).
Word, color, and color-word T-Scores above 40 or are considered "normal", while below 40 is considered "low".
- Change in Controlled Oral Word Association Test (COWAT) Score [ Time Frame: Baseline and 6 weeks ]
The Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and is a subtest of the Multilingual Aphasia Examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters.
The higher the overall score, or number of words listed for each letter, the better their ability to retrieve specific information.
- Change in Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Baseline and 6 weeks ]
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes.
The total possible score is 30 points and can range from 0 to 30; a score of 26 or above is considered normal (high score is a better outcome).
Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
- Change in PHQ-9 Score [ Time Frame: Baseline and 6 weeks ]
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.
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| Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with Cerebral Palsy
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273737
| Contact: Heakyung Kim, MD | 212-342-1395 | hk2641@cumc.columbia.edu | |
| Contact: Nancy Lee, MS | 212-305-9416 | nl2674@cumc.columbia.edu |
| United States, New York | |
| Columbia Irving Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Heakyung Kim, MD 212-342-1395 hk2641@cumc.columbia.edu | |
| Contact: Nancy Lee, MS 212-305-9416 nl2674@cumc.columbia.edu | |
| Principal Investigator: | Heakyung Kim, MD | Columbia Irving Medical Center |
| Responsible Party: | Heakyung Kim, Professor of Rehabilitation and Regenerative Medicine and Pediatrics, Columbia University |
| ClinicalTrials.gov Identifier: | NCT04273737 |
| Other Study ID Numbers: |
AAAS1907 |
| First Posted: | February 18, 2020 Key Record Dates |
| Last Update Posted: | February 18, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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cerebral palsy amantadine cognitive function |
gross motor skills fine motor skills mood |
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Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Amantadine Antiparkinson Agents Anti-Dyskinesia Agents |
Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |