Clinical trial: A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS) (NCT03020797)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment