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SPN-538 for Migraine Prevention in Children
Phase 4
Recruiting
Research Sponsored by Supernus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy male or female (6 to 11 years of age at the time of screening) with a history of migraine with or without aura for at least 6 months prior to screening
3 to 14 headache days (migraine and non-migraine) per month during the 3 months prior to screening and during Baseline Period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial will study whether SPN-538 can prevent migraines in children 6-11 years old.
Who is the study for?
This trial is for children aged 6-11 with a history of migraines, experiencing 3 to 14 headache days per month. They should have a moderate impact on daily activities due to migraines but not suffer from chronic migraine or use certain migraine medications recently. Kids with psychiatric disorders, developmental delays, seizures, brain disorders, suicidal thoughts, pregnancy, or liver/kidney issues can't join.Check my eligibility
What is being tested?
The study tests SPN-538 against a placebo to prevent migraines in kids. It aims to see if SPN-538 reduces the number of headache days and improves life quality compared to no treatment (placebo). Participants are randomly assigned either the real medicine or placebo without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects for SPN-538 aren't listed here, common ones for migraine prevention drugs include nausea, fatigue, dry mouth and dizziness. Some may experience more serious effects like allergic reactions or mood changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy child aged 6-11 with a history of migraines for at least 6 months.
Select...
I've had 3 to 14 headache days a month for the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of migraine attack per 28 days during the Treatment Phase.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SPN-538Experimental Treatment1 Intervention
Patients will be treated with SPN-538 as a single dose once a day
Group II: PlaceboPlacebo Group1 Intervention
Patients will be treated with Placebo once a day
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Who is running the clinical trial?
Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,636 Total Patients Enrolled
1 Trials studying Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a healthy child aged 6-11 with a history of migraines for at least 6 months.I have a history of brain disorders, surgery, or serious head injury.My migraines didn't improve after trying topiramate or more than 2 other prevention treatments.I am currently taking or have taken various medications and supplements.I haven't used migraine prevention medication other than topiramate in the last 14 days or Botox in the last 3 months.I have had seizures or events similar to seizures.Your PedMIDAS Disability score is between 10 and 50.You have been diagnosed with a mental disorder or have documented developmental delays or impairments.I do not have suicidal thoughts, am not pregnant, and my liver and kidneys are functioning normally.You are using too much pain medication or migraine-specific drugs to treat your migraines.I've had 3 to 14 headache days a month for the last 3 months.I experience more than 14 headache days per month.
Research Study Groups:
This trial has the following groups:- Group 1: SPN-538
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research open to geriatric participants?
"This medical study is enrolling individuals aged between 6 to 11 years."
Answered by AI
To what extent is this experiment engaging with human test subjects?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this research trial, which was originally posted on July 14th 2020, is currently seeking volunteers. Approximately 162 participants are required from a single location."
Answered by AI
What type of participants are best suited to join this medical experiment?
"The present clinical trial seeks 162 males and females aged 6 to 11 with a documented history of migraine, 3-14 headaches per month over the preceding three months and a PedMIDAS Disability score between 10 and 50. Additionally, participants must be in good physical health."
Answered by AI
Are there any open enrollment slots available for this research trial?
"Clinicaltrials.gov confirms that this particular medical trial is still seeking prospective participants. The clinical study was launched on July 14th 2020 and the most recent update to its information occurred November 29th 2021."
Answered by AI
To what degree does SPN-538 carry health risks for individuals?
"The safety of SPN-538 has been confirmed through a Phase 4 trial, thereby receiving an assessment score of 3."
Answered by AI
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