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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 May 2023 |
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Main ID: |
NCT03020797 |
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Date of registration:
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15/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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January 12, 2017 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03020797 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Nurcan Gursoy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stony Brook Medicine Dept. of Neurology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. diagnosis of ALS
2. first clinical weakness within past 3 years
3. slow vital capacity >= 60% of predicted within 1 month of treatment
4. may be on stable dose of riluzole for at least 30 days, or otherwise agree to not
initiate riluzole for duration of the trial
5. may be on stable dose of edaravone for at least 30 days, otherwise agree to not
initiate edaravone for duration of the trial
6. can travel to Stony Brook to receive medical care
7. must have a monitor who can be contacted at regular intervals to report on subject's
clinical/psychiatric status
Exclusion Criteria:
1. use of tracheostomy or mechanical ventilation within last 3 months
2. hepatic insufficiency or abnormal liver function
3. renal insufficiency
4. clinically significant psychiatric disorder
5. active malignancy
6. history of HIV, clinically significant chronic hepatitis, or other active infection
7. history of stomach or intestinal surgery or condition that could interfere with
absorption, distribution, metabolism or secretion of study drug
8. history of alcohol or substance abuse within 3 months prior to entry (subjects will be
instructed to refrain from alcohol during the study)
9. use of strong cytochrome P4503A inhibitors or inducers, anticonvulsants or other drugs
known to interact strongly with perampanel.
10. pregnancy or lactation
11. clinically significant medical condition (other than ALS) that would pose a risk to
the subject if they were to participate
12. know hypersensitivity to perampanel
13. currently participating, or has participated in a study with an investigation or
marketed compound within 3 months of entry
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Perampanel
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Drug: Placebo Oral Tablet
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Primary Outcome(s)
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Incidence of treatment-emergent adverse events
[Time Frame: 9 months]
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Secondary Outcome(s)
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Efficacy as measured by change in ALSFRS-R score (ALS functional rating scale-revised);
[Time Frame: 9 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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