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Trial record 49 of 677 for:    amyotrophic lateral sclerosis

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

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.
 
ClinicalTrials.gov Identifier: NCT03679975
Recruitment Status : Terminated (The study is no longer required)
First Posted : September 21, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
inVentiv Health Clinical
Covance
Information provided by (Responsible Party):
Aquestive Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Riluzole Oral Soluble film (ROSF) 50 mg Phase 2

Detailed Description:
This is a single site, single dose, open-label safety study. Approximately thirty (30) individuals with amyotrophic lateral sclerosis (ALS) will be enrolled. Subjects seen in the ALS Clinic at the University of Florida will be screened to determine eligibility according to the specified inclusion/exclusion criteria. Following enrollment and informed consent, subjects will undergo a clinical evaluation including the validated Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS- R). Swallowing safety will be assessed using the gold standard Videofluoroscopic Swallowing Study to afford direct visualization of the swallowing process and any episodes of penetration or aspiration quantified using the validated Penetration Aspiration Scale (PAS). Subjects will undergo a standardized protocol that includes 12 bolus stimuli presentations of different liquid and food materials to test the swallow across a continuum of textures and materials. Immediately following, subjects will be given a single dose of riluzole oral soluble film (ROSF) 50mg, placed on the median lingual sulcus of the dorsum of the tongue. Three minutes after the administration of ROSF, the identical standardized VFSS protocol will be re- administered to allow a comparison of swallowing safety (using the PAS scale) pre vs. post ROSF administration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Approximately 30 subjects with ALS will be enrolled and undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of Riluzole.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : December 21, 2018


Arm Intervention/treatment
Experimental: Subjects with ALS
Subjects with a diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria will be administered a single dose of the Riluzole Oral Soluble Film (ROSF) 50 mg.
Drug: Riluzole Oral Soluble film (ROSF) 50 mg
Enrolled subjects will undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of riluzole.
Other Name: ROSF 50 mg




Primary Outcome Measures :
  1. Difference from baseline in Penetration Aspiration Scale (PAS) [ Time Frame: Before and after administration of ROSF 50 mg on day 1 (visit 1) ]
    The PAS is an 8 point validated scale of swallowing safety that takes into account both degree/level of airway invasion during swallowing and the patients' response to the penetration or aspiration episode. A score of 1 means the swallowed material does not enter the airway. A score of 8 means the material enters the airway passes below vocal folds and no effort is made to eject.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Revisited El-Escorial Criteria (Cedarbaum, 1999)
  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 (Crary, 2005).
  4. Subjects with no known allergy to barium, riluzole or inactive ingredients* in ROSF
  5. Subjects or subject's legally authorized representative must be willing and able to give informed consent/assent and HIPAA authorization.
  6. Subjects must have the ability to comprehend and be informed of the nature of the study, as assessed by the PI or Sub-Investigator.
  7. Subjects prescribed riluzole at or before the dose of study drug. (The study is open to subjects currently taking riluzole at screening, subjects who are not currently taking riluzole at screening who have taken riluzole in the past, and subjects to be newly started on riluzole (given as ROSF in this study.)
  8. Female subjects of childbearing potential must have a negative urine pregnancy test at Screening and Visit 1. 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 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. Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements

Exclusion Criteria:

  1. Subjects who score 2 or below on the Functional Oral Intake Scale (Crary, 2005)
  2. Subjects with a prior swallowing study that has shown a PAS of 3 or greater
  3. Subjects with a history of two 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 are unwilling to sign informed consent or subjects who for any other reason in the judgment of investigator are unable to complete the study
  6. Female subjects who have a positive urine pregnancy test (βhCG) at screening or Visit 1, are trying to become pregnant or are breastfeeding.
  7. Subjects with active cancer within the previous 2 years, except treated basal cell carcinoma of the skin
  8. 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 MonoSol Rx sponsored ROSF clinical studies within the last 30 days prior to enrollment may be eligible for consideration for entry into this study.
  9. Subjects with moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤50 mL/minute
  10. Subjects currently taking riluzole with ALT 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 will be receiving riluzole for the first time who exhibit baseline elevations of several LFTs (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, MonoSol Rx LLC, any of its affiliates or partners, or inVentiv Health.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679975


Locations
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United States, Florida
University of Florida Center for Movement Disorders & Neuroscience
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
Aquestive Therapeutics
inVentiv Health Clinical
Covance

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Responsible Party: Aquestive Therapeutics
ClinicalTrials.gov Identifier: NCT03679975     History of Changes
Other Study ID Numbers: 17MO1R-0012
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents