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Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03457753
Recruitment Status : Withdrawn (The Sponsor stopped the study due to a change in study plans)
First Posted : March 8, 2018
Last Update Posted : May 13, 2019
Inventiv Health
Information provided by (Responsible Party):
Aquestive Therapeutics

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 8, 2018
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
Change from baseline in NCI-CTC score at week 12 [ Time Frame: Week 12 (visit 3) ]
The National Cancer Institute Common Toxicity Criteria (NCI-CTC) score will be used to evaluate the presence or level of oral cavity irritation on an oral examination, with a grading scale ranging from Grade 0 -5 (0 = no toxicity, 1 = painless ulcers, erythema, or mild soreness, 2 = painful erythema, edema, or ulcers but eating or swallowing possible, 3 = painful erythema, edema, or ulcers requiring intravenous hydration, 4 = severe ulceration, and 5 = death related to toxicity).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
Official Title  ICMJE 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.
Brief Summary The primary objective of this study is to assess the safety and tolerability, with emphasis on the oral cavity, of ROSF (containing riluzole 50mg) in subjects with amyotrophic lateral sclerosis (ALS) administered twice daily for 12 weeks. Secondary objectives include (1) to record the subject's assessment of any difficulty taking riluzole administered as ROSF and any difficulty taking riluzole in the tablet formulation and (2) to record the relative preference, if any, of subjects and caretakers, for riluzole administered as ROSF vs. the riluzole tablet.
Detailed Description The total study participant time is expected to be approximately 14 weeks from time of screening to completion of study. Subjects will be instructed on the use of ROSF and receive the first dose of ROSF under supervision of the investigator during Visit 1.Subjects will then continue on ROSF 50mg twice daily for 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a multi-center, open label safety and tolerability trial. Approximately twenty-five (25) individuals with amyotrophic lateral sclerosis (ALS) will be enrolled.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE ALS
Intervention  ICMJE Drug: Riluzole Oral Soluble Film
Riluzole Oral Soluble Film (ROSF) containing Riluzole 50mg .
Other Name: ROSF
Study Arms  ICMJE Experimental: Subjects with ALS
Riluzole Oral Soluble Film (ROSF) 50 mg will be administered in subjects with ALS twice daily. It is intended that at least five (5) of the twenty-five (25) subjects enrolled will be subjects scoring greater than 20 on the Eating Assessment Tool (EAT-10) (representative of ALS patients reporting moderate swallowing impairments in a patient report validated scale).
Intervention: Drug: Riluzole Oral Soluble Film
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 19, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2018)
Actual Study Completion Date  ICMJE March 27, 2018
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03457753
Other Study ID Numbers  ICMJE 17MO1R-0016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Aquestive Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aquestive Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Inventiv Health
  • Covance
Investigators  ICMJE
Principal Investigator: Emily Plowman, PhD, CCC-SLP University of Florida
Principal Investigator: James Wymer, MD, PhD University of Florida
PRS Account Aquestive Therapeutics
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP