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Trial registered on ANZCTR
Registration number
ACTRN12616000714482
Ethics application status
Approved
Date submitted
3/02/2016
Date registered
30/05/2016
Date last updated
23/05/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A Randomised, Cross-over Study to Evaluate Efficacy and Tolerability of FLX-787 in Patients with Multiple Sclerosis spasticity and spasms/cramps
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Scientific title
A Randomised, Cross-over Study to Evaluate Efficacy and Tolerability of FLX-787 in Patients with Multiple Sclerosis spasticity and spasms/cramps
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Secondary ID [1]
288473
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Nil
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Universal Trial Number (UTN)
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Trial acronym
Flex 201
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spasticity & cramps in patients with MS
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Condition category
Condition code
Neurological
297707
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0
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Eligible Subjects will enter the study and commence the Enrolment Period 1, a 14-day period during which all Subjects will receive capsules, the capsules will be consumed twice daily, one in the morning and once in the evening.
Upon completion of Period 1, Subjects who remain eligible will be randomised to one of two possible treatment sequences (Inactive Control – FLX-787 or FLX-787 – Inactive Control). FLX-787 or Inactive Control are both oral beverages which will be taken twice daily for one of two 14-day Cross-over Periods. Self-administration will take place in the morning approximately within an hour of rising and in the evening approximately 45 minutes before going to bed.
Subjects will be allocated to each treatment sequence in a 1:1 ratio. There will be a 7-14 day Wash-out Period between Period 1 and Period 2. Each Cross-over Period (Periods 2 and 3) is 14 days. There will be a 7-14 day Wash-out Period between Periods 2 and 3.
Assessments will be performed and surveys will be completed at each clinic visit according to the study events flow chart.
In addition to the in-clinic assessments, Subjects will be completing daily telephone surveys through an Interactive Voice Response System (IVRS) to document information on the previous days muscle spasms/cramps (including number of, time, duration, location, and pain level), the level of spasticity according to the NRS and study product compliance.
Subjects will return to the centre for an End of Treatment Visit (or Early Termination Visit if they withdraw before the end of the study).
In addition, a follow-up telephone interview to assess adverse events (AEs) will take place 30 days after the last administration of the study product.
Each clinic visit will have a +3-day visit window after the due date to account for scheduling conflicts/holidays/weekends.
Subjects will be given an additional six (6) doses of study product to allow for continued dosing through the 3-day visit window if needed.
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Intervention code [1]
293810
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Treatment: Drugs
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Comparator / control treatment
25ml, inactive beverage consumed orally twice daily, morning and evening
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The alternate primary objectives of this study are to assess the effects of FLX-787 in multiple sclerosis (MS) Subjects with spasticity and spasms/cramps as measured by:
Modified Ashworth Scale (MAS); measuring muscle tone
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Assessment method [1]
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Timepoint [1]
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At screening, Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2) & Day 64 (Visit 6, Day 14 of Cross-over Period 3)
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Primary outcome [2]
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Tardieu Scale (TS);
measures muscle response to passive movement at set velocities
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Assessment method [2]
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Timepoint [2]
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At screening, Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2) & Day 64 (Visit 6, Day 14 of Cross-over Period 3)
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Primary outcome [3]
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Numerical Rating Scale (NRS);
a patient self assessment, measuring muscle spasticity on a 10 point scale
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Assessment method [3]
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Timepoint [3]
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At screening, Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2), Day 64 (Visit 6, Day 14 of Cross-over Period 3) and Visit 7 (drop out visit),
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Secondary outcome [1]
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Tolerability will be measured by AEs, Laboratory Evaluations and Vital Signs. AEs will be monitored and collected from the time the ICF is signed through the follow up call (30 days post last study product administration). Laboratory evaluations and vital signs will be assessed throughout the study.
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Assessment method [1]
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Timepoint [1]
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At screening, Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2), Day 64 (Visit 6, Day 14 of Cross-over Period 3) and Visit 7 (drop out visit),
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Secondary outcome [2]
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Barthel Activities of Dailey living, measures performance in activities of daily living
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Assessment method [2]
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Timepoint [2]
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Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2) & Day 64 (Visit 6, Day 14 of Cross-over Period 3)
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Secondary outcome [3]
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Timed 25-Foot Walk; measures patients quantitative mobility and leg function
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Assessment method [3]
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Timepoint [3]
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Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2) & Day 64 (Visit 6, Day 14 of Cross-over Period 3)
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Secondary outcome [4]
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Clinical Global Impression; measures global rating of illness severity, improvement and response to treatment
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Assessment method [4]
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Timepoint [4]
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Day 29 (Visit 3, Day 14 of Run-in Period 1) & Day 64 (Visit 6, Day 14 of Cross-over Period 3)
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Secondary outcome [5]
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Quality of Life Questionnaires:
36-Item Short Form Survey; patient-reported survey of patient health. Scoring general health and pain.
Multiple Sclerosis Spasticity Scale; measure the impact of spasticity in multiple sclerosis
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Assessment method [5]
321703
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Timepoint [5]
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Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2), Day 64 (Visit 6, Day 14 of Cross-over Period 3) and Visit 7 (drop out visit),
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Secondary outcome [6]
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Insomnia Severity Index Sleep Survey; for the evaluation of insomnia
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Assessment method [6]
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Timepoint [6]
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Day 15 (Visit 2, day -1 Run-in Period 1), Day 29 (Visit 3, Day 14 of Run-in Period 1), Day 43 (Visit 4, end Cross-over Period 2), Day 64 (Visit 6, Day 14 of Cross-over Period 3) and Visit 7 (drop out visit),
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Eligibility
Key inclusion criteria
1. Diagnosed with any sub-type of MS for at least 6 months except for Subjects with acute relapse within 4 weeks of Screening;
2. Spasticity of at least 3 months duration that is not completely relieved by current therapy;
3. Naïve Subjects or Subjects who are on antispasmodic medication for at least 30 days;
4. Males will agree to use a medically acceptable method of contraception and will refrain from sperm donation throughout the duration of the study; and,
5. All females, regardless 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.
6. Subjects who have =6 cramps during Period 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any concomitant disease or disorder that has symptoms of spasticity, or that may influence the Subject’s level of spasticity;
2. Subjects who are suffering from an acute relapse or have suffered an acute relapse within 4 weeks of Screening;
3. Expanded Disability Status Scale equal or greater than 7;
4. Significant cardiac, renal or hepatic impairment;
5. Started or altered the dose levels of any of the following agents: skeletal muscle relaxants (i.e. Flexerol), anti-spasm drugs or anti-convulsants within 6 weeks prior to the first administration of study product;
6. Subjects currently taking over the counter medications or dietary supplements to treat cramps or spasms (including topical patches);
7. Subjects using strong tranquilizers such as benzodiazepines;
8. Subjects using street drugs such as marijuana;
9. Subjects who have a food allergy or intolerance/hypersensitivity to products containing ginger;
10. Abuse of any illicit drugs or alcohol within the past 1 year prior to the Screening and throughout the duration of the study;
11. Subjects with diabetes;
12. Subjects with Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) and/or Hepatitis C Virus (HCV);
13. Participation in an interventional clinical study within 30 days prior to the first administration of study product;
14. Subjects who are unlikely/unwilling to refrain from eating spicy foods or beverages throughout the study (for example, cinnamon, ginger, chilli peppers, hot sauces, mustard, pickles);
15. Subjects who have medical fragility, e.g., a Body Mass Index (BMI) falling below the lower threshold of the healthy adult reference range, or a history of recurrent hospital readmissions;
16. Subjects whose other conditions/diseases are unstable and are likely to result in changes in their concomitant medication (to avoid doubt this includes the addition of new medications or change of dose in an existing medication.);
17. Subjects who are unable to complete the T25-FW; and,
18. Subjects who in the opinion of the Investigator are not suitable to participate in this clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer generated list held by unblinded pharmacist
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized randomisation scheme created by study statistician
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
80 participants will be recruited and will be randomly allocated to receive beverage in a crossover manner.
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2016
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Actual
2/06/2016
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Date of last participant enrolment
Anticipated
1/03/2017
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Actual
17/11/2017
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Date of last data collection
Anticipated
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Actual
29/01/2018
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Sample size
Target
80
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Accrual to date
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Final
73
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Brain and Mind Centre - University of Sydney - Camperdown
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Recruitment hospital [2]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [3]
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John Hunter Hospital Royal Newcastle Centre - New Lambton
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Recruitment hospital [4]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [5]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [6]
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [7]
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Griffith University Clinical Trials Unit - Southport
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Recruitment hospital [8]
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Calvary Wakefield Hospital - Adelaide
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Recruitment postcode(s) [1]
13294
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2050 - Camperdown
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Recruitment postcode(s) [2]
22750
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2065 - St Leonards
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Recruitment postcode(s) [3]
13293
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2305 - New Lambton Heights
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Recruitment postcode(s) [4]
12693
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3050 - Royal Melbourne Hospital
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Recruitment postcode(s) [5]
12694
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3084 - Heidelberg
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Recruitment postcode(s) [6]
22751
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3168 - Clayton
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Recruitment postcode(s) [7]
22752
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4215 - Southport
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Recruitment postcode(s) [8]
22753
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Flex Pharma, Inc
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Address [1]
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Prudential Tower
800 Boylston St.
24th Floor, Boston MA 02199
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Flex Pharma, Inc
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Address
Prudential Tower
800 Boylston St
24th Floor, Boston MA 02199
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Country
United States of America
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Neuroscience Trials Australia
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Address [1]
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345 Burgundy St.
Heidelberg Victoria 3084
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
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Royal Melbourne Hospital Parkville VIC 3050
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Ethics committee country [1]
294322
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Australia
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Date submitted for ethics approval [1]
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21/10/2015
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Approval date [1]
294322
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16/12/2015
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Ethics approval number [1]
294322
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HREC/15/MH/332
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Summary
Brief summary
The study aims to evaluate the effects and safety of FLX-787 in patients with MS who experience muscle cramps and spasms. We aim to assess the effect of FLX-787 on muscle spasms/cramps. FLX-787 is self administered morning and evening. Flex Pharma hypothesizes that activating Transient Receptor Potential (TRP) ion channels, which are known to exist in primary sensory neurons in the mouth, oesophagus and gut increase inhibitory tone in the spinal cord and prevents repetitive firing of alpha neurons thereby relieving the cramp. This study investigates whether the ingredients in FLX-787 activate the TRP ion channels relieve muscle cramps in paitents with MS
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Anneke Van der Walt
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Address
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Royal Melbourne Hospital
Level 4, Main Building
300 Grattan St.
Parkville VIC 3050
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Country
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Australia
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Phone
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+61 3 93429092
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Fax
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+61 3 93495997
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Email
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anneke.vanderwalt@mh.org.au
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Contact person for public queries
Name
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Tina Soulis
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Address
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Neuroscience Trials Australia
245 Burgundy St
Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 90357158
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Fax
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Email
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asoulis@unimelb.edu.au
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Contact person for scientific queries
Name
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Laura Rosen
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Address
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FlexPharma Inc
Prudential Tower
800 Boylston St, 24th Floor
Boston MA 02199
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Country
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United States of America
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Phone
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+1 484 5474729
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Fax
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Email
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lrosen@flex-pharma.com
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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