Clinical trial: Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis (NCT03457753)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female subjects, between 18-80 years of age, inclusive.

          2. Subjects having a diagnosis of probable or definite ALS in accordance with the
             Revisited El-Escorial Criteria.

          3. Subjects must have no known allergy to riluzole or inactive ingredients* in ROSF.

          4. Subjects or subject's legally authorized representative must be willing and able to
             complete informed consent/assent and HIPAA authorization.

          5. Ability to comprehend and be informed of the nature of the study, as assessed by the
             Primary or Sub-Investigator.

          6. Subjects prescribed to take riluzole at or before the time of first dose. (The study
             is open to subjects currently taking riluzole at screening, subjects who are not
             currently taking riluzole at screening but who have taken riluzole in the past, and
             subjects to be newly started on riluzole (given as ROSF in the course of this study).

          7. Availability to volunteer for the entire study duration and willing to adhere to all
             protocol requirements.

          8. Female subjects of childbearing potential must have a negative urine pregnancy test at
             Screening and Visit 1-3. Female subjects of childbearing potential (i.e. not
             surgically sterile, not 2 years postmenopausal, or not with a sterile partner) must
             have a negative pregnancy test at screening and Visit 1-3, agree to abstinence,
             practicing double barrier contraception or using an FDA approved barrier method
             contraceptive (e.g., licensed hormonal or barrier methods) for greater than 2 months
             prior to screening visit and commit to an acceptable form of birth control for the
             duration of the study and for 30 days after participation in the study.

          9. Subjects, in the judgment of the investigator, must be suitable candidates for
             administration of ROSF (riluzole oral soluble film).

        Exclusion Criteria:

          1. Subjects with a history of clinically significant liver disease, renal disease, or any
             other medical condition judged to be exclusionary by the investigator.

          2. Subjects who are unwilling to sign informed consent or subjects who for any other
             reason in the judgment of investigator are unable to complete the study.

          3. Female subjects who have a positive urine pregnancy test (βhCG) at screening or visit
             1, are trying to become pregnant or are breastfeeding.

          4. Subjects with active cancer within the previous 2 years, except treated basal cell
             carcinoma of the skin.

          5. Subjects who have taken any experimental drug within 30 days prior to enrollment or
             within 5 half-lives of the investigational drug -whichever is the longer period.
             However, subjects who have previously completed other Aquestive sponsored ROSF
             clinical studies within the last 30 days prior to enrollment may be eligible for
             consideration for entry into this study.

          6. Subjects with known history or presence of moderate or severe renal impairment as
             defined by a calculated creatinine clearance of ≤50 mL/minute.

          7. Subjects currently taking riluzole with alanine aminotransferase (ALT) levels greater
             than 5 times upper limit of normal or with evidence of clinical jaundice. (Riluzole
             should be discontinued in these patients.)

          8. Subjects who will be receiving riluzole for the first time who exhibit baseline
             elevations of several liver function tests (especially elevated bilirubin). (These
             findings at baseline should preclude the use of riluzole including ROSF.)

          9. Use of potentially hepatotoxic drugs: (e.g., allopurinol, methyldopa, sulfasalazine).

         10. Subjects with clinically significant abnormal laboratory values in the judgment of the
             investigator.

         11. Use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin,
             fluvoxamine, methoxsalen, mexiletine, thiabendazole, vemurafenib, zileuton) and CYP1A2
             inducers (e.g. rifampin and barbiturates) in the previous 30 days before first drug
             administration.

         12. Employee or immediate relative of an employee of the investigator, MonoSol Rx LLC, any
             of its affiliates or partners, or inVentiv Health.

         13. Anything else that, in the opinion of the investigator, would place the subject at
             increased risk or preclude the subject's full compliance with or completion of the
             study.
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