Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)

• Status: Terminated
• Trial end date: 2018-12-21
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the effect, if any, of a single 50 mg dose of Riluzole Oral Soluble Film (ROSF) on swallowing safety in individuals with amyotrophic lateral sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aquestive Therapeutics
• Collaborators: Covance; inVentiv Health Clinical
• Treatments: Riluzole

Criteria

Inclusion Criteria:

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

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

3. Subjects must be currently on an oral diet and able to take foods and liquids by mouth equivalent to a score of 3 or above on the Functional Oral Intake Scale.

4. Subjects with no known allergy to barium, riluzole or inactive ingredients in ROSF

5. Subject or subject's legally authorized representative must be willing and able to give informed consent/assent and HIPAA authorization.

6. Subject must have the ability to comprehend and be informed of the nature of the study, as assessed by the Principal Investigator or Sub-Investigator.

7. Subjects prescribed riluzole at or before the dose of study drug. (The study was open to subjects currently taking riluzole at screening, subjects who were not currently taking riluzole at screening who had taken riluzole in the past, and subjects to be newly started on riluzole (given as ROSF in this study).

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

9. 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, agree to abstinence, be practicing double barrier contraception or using an FDA approved barrier method contraceptive (e.g., licensed hormonal or barrier methods) for more than 2 months prior to the 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.

Exclusion Criteria:

1. Subjects who score 2 or below on the Functional Oral Intake Scale.

2. Subjects with a prior swallowing study that has shown a Penetration Aspiration Scale score of 3 or greater

3. Subjects with a history of 2 or more episodes of aspiration pneumonia requiring hospitalization

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

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

6. Female subjects who had a positive urine pregnancy test (βhCG) at screening or Visit 1, were trying to become pregnant, or were breastfeeding.

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

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

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

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

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

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

13. Subjects with clinically significant abnormal laboratory values in the judgment of the Investigator

14. 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.

15. 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.

16. Employee or immediate relative of an employee of the investigator, Aquestive Therapeutics, any of its affiliates or partners, or inVentiv Health.