A trial to evaluate the effect of FLX-787 ODT on Motor Neuron Disease.
A Randomised, Cross-over Study to Evaluate Efficacy and Tolerability of FLX-787 in Patients with Motor Neuron Disease
Flex Pharma, Inc
50 participants
Sep 16, 2016
Interventional
Conditions
Summary
The study aims to evaluate the effects and safety of FLX-787 in patients with Motor Neuron Disease who experience muscle cramps and spasms. We aim to assess the effect of FLX-787 on pain/intensity and insomnia. Active/Placebo ODT is self administered morning and evening.
Eligibility
Inclusion Criteria7
- Diagnosed with Amyotrophic Lateral Sclerosis (ALS) or Progressive Lateral Sclerosis (PLS) for at least 12 months;
- Subjects must be able to provide written informed consent;
- Subjects must be able and willing to comply with all study requirements;
- Subjects must be able to take the study products;
- Spasticity of at least 3 months duration that is not completely relieved by current therapy;
- Subjects with an estimated > 60 cramps per month (or > 15 per week); and,
- All females of childbearing potential will agree to use a medically acceptable method of contraception throughout the duration of the study and have a negative urine pregnancy test at screening.
Exclusion Criteria10
- Subjects with flaccid paralysis;
- Subjects with significant cognitive impairment, clinical dementia or psychiatric illness;
- Subjects with a diagnosis of another neurodegenerative disease (e.g. Parkinson disease, Alzheimer disease);
- Subjects who have a food allergy or intolerance/hypersensitivity to products containing ginger;
- Subjects with a history of abuse of any street drugs such as marijuana or illicit drugs or alcohol within the past 1 year prior to signing the Informed Consent Form (ICF);
- Use of any tobacco- or nicotine-containing products within 1 week prior to Screening and throughout the duration of the study;
- Subjects who participated in an interventional clinical study within 30 days prior to the first administration of study product;
- Subjects whose other conditions/diseases are unstable and are likely to result in hospitalisation or a change in their medication regimen;
- Subjects who are pregnant or lactating; and,
- Subjects who in the opinion of the Investigator are not suitable to participate in this clinical trial.
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Interventions
Subjects will be asked to consume two study products (placebo and active) during the screening visit. Eligible Subjects who can consume the products will enter the study and commence Run-In, a 14 day period. During the 14 day Run-In period all subjects will complete a daily telephone questionnaire through an IVRS to document information on the previous day's cramps as well as obtain information on Subjects Spacticity through the measurement of the NRS. Upon completion of the Run-In, Subjects will be randomised to one of two possible sequences (Control - Active or Active - Control). Subjects will be allocated to each sequence in a one to one ratio. Subjects will be instructed to take study product two times a day, morning and evening.. Each Cross-over Period (Periods 1 and 2) is 14 days. There will be a 7-day Wash-out between Period 1 and Period 2 Subjects will be given additional study product to account for a 3 day window and potential spills/contamination. Each treatment may include a combination of any of the following: Component of Ginger Ethanol alcohol (trace amount) Lactose Sucrose Aspartame Water Participants will consume a single oral disintegrating tablet twice daily, morning and evening. Adherence to the intervention will be monitored via product return.
Locations(3)
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ACTRN12616001060437