Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03457753
• Date of registration: 26/02/2018
• Prospective Registration: Yes
• Primary sponsor: Aquestive Therapeutics
• Public title: Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
• Scientific title: A Multi-Center, Open Label Study to Assess the Safety and Tolerability of Riluzole Oral Soluble Film in Subjects With Amyotrophic Lateral Sclerosis Over 12 Weeks of Twice Daily Treatment.
• Date of first enrolment: March 1, 2018
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03457753
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Emily Plowman, PhD, CCC-SLP
• Affiliation: University of Florida

• Name: James Wymer, MD, PhD
• Affiliation: University of Florida

Key inclusion & exclusion 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 (ßhCG) 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

ALS

Intervention(s)

Drug: Riluzole Oral Soluble Film

Primary Outcome(s)

Change from baseline in NCI-CTC score at week 12 [Time Frame: Week 12 (visit 3)]

Secondary ID(s)

17MO1R-0016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Covance

Inventiv Health