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Fampridine for Optic Neuritis (FAMP-ON Trial)
FAMP-ON Trial Summary
This trial is testing whether the drug Fampridine-SR can help improve vision for people who have had optic neuritis, a condition that damages the optic nerve.
FAMP-ON Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FAMP-ON Trial Design
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- You had a serious eye condition called optic neuritis more than a year ago and it didn't fully get better.Your vision in the affected eye is better than 20/40.You have a medical condition that could affect your vision, such as diabetes-related eye problems, glaucoma, cataracts, previous eye injury, lazy eye, or non-demyelinating optic nerve issues.Your kidneys are not working well enough, with a creatinine clearance of 80 mL/min or lower.You can't take certain medications that may affect your vision or make you drowsy, unless you haven't changed the dose for at least 30 days before joining the study or during the study. These medications include certain types of tranquilizers, painkillers, and cannabis products, except if taken every night at bedtime.You have had seizures in the past, except for seizures caused by fever when you were a baby.You are taking a medication that blocks Organic Cation Transporter 2 (OCT-2).You have been diagnosed with multiple sclerosis (MS).There is a difference of 20 milliseconds or more in the VEP (Visual Evoked Potential) between your eyes.Your affected eye has a delayed visual response.
- Group 1: Fampridine-SR
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do I meet the criteria to partake in this medical study?
"The criteria for eligibility in this study requires that prospective candidates have optic neuritis and must be within the age span of 18 to 64. The total number of participants needed is 20 individuals."
Are any slots available for enrolment in this experimental protocol?
"Affirmative. Per the information hosted on clinicaltrials.gov, this research project is currently recruiting individuals to take part in it. The study was first posted on March 22nd 2022 and the most recent update was done on August 22nd 2022. A total of 20 participants are required for a single medical facility."
How many volunteers are engaged in this clinical investigation?
"Affirmative. Information available via clinicaltrials.gov suggests that the recruitment phase for this experiment is ongoing, having first been posted on March 22nd 2022 and last edited August 22nd of the same year. 20 participants are required from one specified medical centre."
Has Fampridine SR been tested in any other clinical trials?
"Currently, Fampridine SR is being studied in 5 clinical trials - 2 of which are Phase 3. Most of these studies run out of Basel, BS but there are 9 medical sites overall conducting research on this treatment."
Does this clinical trial permit adults aged 25 and over to participate?
"This clinical trial allows people aged 18 and up to 64 years old, as long as they meet the other criteria for eligibility."
Who else is applying?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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