A Phase 1/2 interventional study of FLX-787-ODT (orally disintigrating tablet) in Amyotrophic Lateral Sclerosis and Fasciculation, sponsored by Flex Pharma, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Flex Pharma, Inc. · Phase 1/2, Interventional, and Treatment
The FLX-787-106 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →Flex Pharma, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FLX-787-ODT (orally disintigrating tablet)
Drug: FLX-787-ODT (orally disintigrating tablet)
Oral Disintegrating Tablet
Change from Baseline of Diastolic Blood Pressure in mmHg
Diastolic blood pressure collected before and after treatment
Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit
Change from Baseline of Systolic Blood Pressure in mmHg
Systolic blood pressure collected before and after treatment
Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit
Change from Baseline in Heart Rate in beats per minute
Heart rate collected before and after treatment
Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit
Change from Baseline in Respiration Rate in breaths per minute
Respiration rate collected before and after treatment
Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit
Change from Baseline in Body Temperature in degrees Celsius or Fahrenheit
Body temperature collected before and after treatment
Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit
Change from Baseline of Oral Cavity Examination
Oral Cavity Examination performed before and after treatment
Time frame: Prior to and twice within 4 hours following administration of investigational product on the clinic visit
Incidence of Treatment-Emergent Adverse Events
Adverse Event Information collected throughout the study
Time frame: Prior to and following administration of investigational product on the clinic visit with AEs followed for 7 days after by telephone contact
Change from Baseline of Fasciculation Frequency
Fasciculations over time measured by EMG before and after treatment
Time frame: Prior to and twice within 4 hours following administration of investigational product on the clinic visit
Change from Baseline of Fasciculation Frequency
Fasciculations over time measured by ultrasound before and after treatment
Time frame: Prior to and twice within 4 hours following administration of investigational product on the clinic visit
Plan to share: Undecided
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This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →
Flex Pharma, Inc.