Trokendi Xr

Migraine, Caloric Restriction, High cholesterol + 16 more
Treatment
20 Active Studies for Trokendi Xr

What is Trokendi Xr

TopiramateThe Generic name of this drug
Treatment SummaryTopiramate is an anticonvulsant medication used to treat seizures and prevent migraines. It was first approved by the FDA in 1996. In 2004, it was also approved for the prevention of migraines in adults. Since 2012, it has been approved in combination with phentermine to help adults manage their weight. It has a unique chemical structure and is made up of 40% oxygen. It was created when scientists were trying to create a new diabetes drug.
Topamaxis the brand name
image of different drug pills on a surface
Trokendi Xr Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Topamax
Topiramate
1997
526

Effectiveness

How Trokendi Xr Affects PatientsTopiramate is used to prevent seizures and treat migraine symptoms by decreasing activity in the brain. It may cause dangerous side effects such as metabolic acidosis, mood changes, suicidal thoughts and attempts, and kidney stones. When taken with valproic acid, topiramate can also lead to hypothermia.
How Trokendi Xr works in the bodySeizures are caused by uncontrolled electrical activity in the brain. Topiramate works to reduce this activity in order to treat seizures and migraines. It does this by affecting GABA receptors, which normally inhibit nerve activity, and glutamate receptors, which stimulate activity. By increasing GABA activity and decreasing glutamate activity, topiramate blocks nerve signals from firing, preventing seizures and migraines. It also blocks voltage-dependent sodium channels in the brain, another way of reducing seizure activity. It is also known to affect certain carbonic anhydrase molecules, but we don't know what effect this has yet.

When to interrupt dosage

The prescribed measure of Trokendi Xr is contingent upon the diagnosed state, such as Seizures, Weight Reduction and Tonic - clonic seizures. The amount of dosage can be found in the table below, depending on the administration technique (e.g. Tablet, coated or Tablet).
Condition
Dosage
Administration
Obesity
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Alcoholism
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Exercise
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Lennox Gastaut Syndrome
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Migraine
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Caloric Restriction
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
High cholesterol
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Obesity
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
at least one weight-related comorbid condition
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Migraine Disorders
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Obesity
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Seizures
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Type 2 Diabetes
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Hypertensive disease
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Epilepsy
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Weight Loss
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
increase in physical activity
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Mood Disorders
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution
Chronic Weight Management therapy
, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, extended release - Oral, Capsule, extended release, Capsule, coated pellets - Oral, Capsule, coated pellets, Capsule, Capsule - Oral, Solution - Oral, Solution

Warnings

Trokendi Xr Contraindications
Condition
Risk Level
Notes
Acidosis
Do Not Combine
There are 20 known major drug interactions with Trokendi Xr.
Common Trokendi Xr Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The metabolism of Abemaciclib can be increased when combined with Topiramate.
Acalabrutinib
Major
The metabolism of Acalabrutinib can be increased when combined with Topiramate.
Acenocoumarol
Major
The metabolism of Acenocoumarol can be increased when combined with Topiramate.
Alectinib
Major
The metabolism of Alectinib can be increased when combined with Topiramate.
Alpelisib
Major
The metabolism of Alpelisib can be increased when combined with Topiramate.
Trokendi Xr Toxicity & Overdose RiskRats have been found to tolerate doses of up to 1500mg/kg of topiramate. In humans, overdosing on topiramate can cause symptoms ranging from mild to severe, such as low blood pressure, extreme acidosis, abdominal pain, seizures, confusion, dizziness, depression, and more. To treat an overdose, doctors may induce vomiting, give activated charcoal, or use dialysis.
image of a doctor in a lab doing drug, clinical research

Trokendi Xr Novel Uses: Which Conditions Have a Clinical Trial Featuring Trokendi Xr?

At present, there are 313 active trials investigating the potential of Trokendi Xr to address Type 2 Diabetes, Migraine and Exercise-associated conditions.
Condition
Clinical Trials
Trial Phases
Exercise
56 Actively Recruiting
Not Applicable, Phase 2, Phase 3, Phase 1
Weight Loss
0 Actively Recruiting
Mood Disorders
0 Actively Recruiting
Migraine
51 Actively Recruiting
Phase 4, Not Applicable, Phase 1, Phase 3, Phase 2, Early Phase 1
Obesity
0 Actively Recruiting
Chronic Weight Management therapy
0 Actively Recruiting
Migraine Disorders
1 Actively Recruiting
Phase 3
Hypertensive disease
27 Actively Recruiting
Not Applicable, Phase 1, Phase 2, Phase 3
Seizures
5 Actively Recruiting
Phase 3, Phase 2, Phase 1
High cholesterol
0 Actively Recruiting
Obesity
0 Actively Recruiting
at least one weight-related comorbid condition
0 Actively Recruiting
Lennox Gastaut Syndrome
2 Actively Recruiting
Phase 1, Phase 2, Phase 4
Obesity
0 Actively Recruiting
Caloric Restriction
0 Actively Recruiting
Epilepsy
0 Actively Recruiting
Alcoholism
7 Actively Recruiting
Not Applicable, Phase 2, Phase 3
Type 2 Diabetes
167 Actively Recruiting
Not Applicable, Phase 1, Phase 2, Phase 3, Phase 4, Early Phase 1
increase in physical activity
0 Actively Recruiting

Trokendi Xr Reviews: What are patients saying about Trokendi Xr?

5Patient Review
1/16/2020
Trokendi Xr for Migraine Prevention
I was 60 when I developed cluster headaches. tried Topamax regular and had the same side effects as others have described. My neuro switched me to the 25mg XR, and no more side effects, and about 1 cluster headache per year now.
4.7Patient Review
11/13/2017
Trokendi Xr for Migraine Prevention
I've only had one migraine in the five months since I started this treatment, which is amazing because I was getting them two to three times a week previously. .25m at night does the trick for me with no negative side effects that I can tell.
4.3Patient Review
1/10/2018
Trokendi Xr for Essential Tremor
Trokendi XR was recommended to me by my doctor, and I'm glad I gave it a try. After trying out different strengths, I found that the 50mg dosage worked best for me in terms of reducing hand shaking and other symptoms. The generic version didn't work as well for me, so be aware of that when you're considering this drug.
2.3Patient Review
5/31/2018
Trokendi Xr for Migraine Prevention
At first, this medication seemed to help. I increased the dosage from 25mg to 50mg to 100mg. However, at 100mg I felt completely useless and bedridden. Tingling in my fingers and feet was a constant issue throughout the entire process. Now that I'm stopping the medication, I'm experiencing bone pain, tingling fingers and feet, frequent urination, back pain, and signs of kidney stones – all considered serious side effects.
1.7Patient Review
11/29/2021
Trokendi Xr for Migraine Prevention
Dizziness, slurred speech, short term memory loss, no energy, loss of appetite, forgetful, frequent urination with incontence, hair breaking/ loss, very brittle finger / toe nails, increase headaches. These are just some of the issues I experienced while taking this medication. Please do not take it. I went cold turkey and after a bit more than two weeks felt so much better. Also able to start managing my life again.
1Patient Review
5/12/2018
Trokendi Xr for Migraine Prevention
I have only been taking Trokendi for a short while, but it has already caused me serious problems. I started hallucinating a few hours after taking the medication, and it has made my speech slurred and walking difficult. I will be asking my neurologist to take me off this med as soon as possible. It also is not helping my migraines at all and has given me terrible acne.
1Patient Review
1/10/2020
Trokendi Xr for Migraine Prevention
I was taking topiramate 25mg twice daily and it helped reduce my migraines to about 2-3 per month. However, when my neuro prescribed Trokendi XR at 25mg and then 50mg, my migraines came back with a vengeance. I'm going back on the topiramate soon if things don't improve.
1Patient Review
5/10/2021
Trokendi Xr for Migraine Prevention
This medication was extremely dangerous and almost killed me. I lost 30 pounds as a result of taking it, and my BP plummeted to 53/30. I also developed neuropathy in both hands (which is now permanent) and suffered from fatigue, hair loss, and nail loss. This medication ruined my life and I would urge anyone considering taking it to avoid doing so at all costs.
1Patient Review
9/10/2021
Trokendi Xr for Migraine Prevention
The side effects were really intense and debilitating. I felt constantly dizzy, my speech was slurred, and I had a lot of trouble concentrating or thinking clearly. On top of all that, I also experienced extreme anxiety. Luckily, I only lost 12 pounds in the two weeks that I took this medication.
1Patient Review
4/15/2019
Trokendi Xr for Migraine Prevention
I had terrible side effects that began after only six weeks of taking the medication. I was constantly feeling low, exhausted, and anxious. If you have any history of mental illness or depression, I would not recommend this drug. It made me feel insane. Within two days of stopping the medication, most of the side effects dissipated. However, I still suffer from migraines on a daily basis.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about trokendi xr

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Trokendi XR make you sleepy?

"Trokendi may cause tiredness, sleepiness, drowsiness, dizziness, changes in vision, and slowed reactions. The use of alcohol with Trokendi may increase these side effects."

Answered by AI

What is Trokendi XR used for?

"Trokendi XR is a prescription medicine that is used to prevent migraines in adults and adolescents who are at least 12 years old. It is also used to treat certain types of seizures in people who are at least 6 years old."

Answered by AI

Is Trokendi XR the same as Topamax?

"Both drugs contain the same active ingredient called topiramate. Trokendi XR comes as an extended-release (long-acting) oral capsule and Topamax come as an immediate-release tablet or capsule. Trokendi XR is taken once a day, while Topamax is usually taken twice a day, in the morning and evening."

Answered by AI

Is Trokendi XR used for weight loss?

"While Trokendi XR is not approved as a weight loss medication, it is common for patients to lose weight while taking the drug, especially at higher doses. Your doctor may prescribe Trokendi XR off-label for binge eating disorder. If you have questions about Trokendi XR and weight loss, speak with your doctor."

Answered by AI

Clinical Trials for Trokendi Xr

Image of U Health in Miami, United States.

Cuffless PPG Monitor for High Blood Pressure

18+
All Sexes
Miami, FL
This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.
Waitlist Available
Has No Placebo
U Health (+1 Sites)Ziad Zoghby, M.D., M.B.A.Biobeat Technologies Ltd.
Image of University of California, Los Angeles in Los Angeles, United States.

Tailored DPP for Prediabetes

17 - 25
All Sexes
Los Angeles, CA
The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are: Aim 1 - Evaluate the efficacy of an AYA-tailored version of the UC DPP for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months). Aim 2 - Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will recruit 80 UCLA undergraduate students. Participants will be asked to complete a brief screening online form to assess eligibility and to collect contact information. The PI and/or Research Assistants (RAs) will reach out to eligible participants to obtain informed consent and enroll them in the pilot trial. The investigators will randomize participants to the tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the tailored DPP in the following academic year. The tailored DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete. Control group will receive each intervention materials via e-mail for participants to review on their own time and will receive acceptability surveys. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. Control group will receive access to a study habits intervention, alcohol use intervention, and financial literacy intervention. At the end of each quarter (Fall, Winter, and Spring), both control and intervention participants will receive an email with a unique link to a brief REDCap survey to ascertain acceptability of sessions/lessons. Furthermore, participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.
Recruiting
Has No Placebo
University of California, Los AngelesLauren E Wisk, PhD
Have you considered Trokendi Xr clinical trials? We made a collection of clinical trials featuring Trokendi Xr, we think they might fit your search criteria.Go to Trials
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PATAS for Type 2 Diabetes

18 - 55
All Sexes
Cincinnati, OH
The primary objective of Part 1 of this study is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of Part 1 of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 of this study are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. The secondary objectives of Part 2 of this study are to evaluate the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers; and to characterize the adverse event (AE) profiles of the various dose levels of PATAS.
Phase 1
Waitlist Available
Medpace Clinical Pharmaology UnitVincent Marion, Ph.D.AdipoPharma LLC
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Embolization for Migraine

18 - 80
All Sexes
Baltimore, MD
This study is to test the safety and feasibility of a procedure called embolization of the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a plug in the arteries. MMA embolization with Onyx is not approved for use in patients with migraines, but is currently used in patients with subdural hematomas. The FDA is allowing the use of Onyx in this study. It is thought that by using Onyx to block the middle meningeal arteries, the amount of migraine-causing substances which are released into the brain's bloodstream will be reduced. The company that manufactures Onyx, Medtronic, is providing the supplies for this study. Participants will be in the study for about 8 months after enrolling, including 6 months of follow up after the procedure. The participants will be asked to complete a daily headache diary and continue the participant's regular migraine medications. Participants will also have several clinic visits and be asked to provide blood samples for research.
Waitlist Available
Has No Placebo
Johns Hopkins MedicineRisheng Xu, MD, PhDMedtronic
Have you considered Trokendi Xr clinical trials? We made a collection of clinical trials featuring Trokendi Xr, we think they might fit your search criteria.Go to Trials
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Deep TMS for Alcoholism

18 - 86
All Sexes
Tuscaloosa, AL
The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases: 1. Pre-study Screening and Baseline Phase 2. Acute Treatment Phase and 3. Maintenance Treatment and Follow up Phase Subjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration. Eligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks. The Maintenance Treatment \& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit. At each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered. The study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2-4, based on the Time Line Follow Back (TLFB) reporting. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving. Safety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.
Recruiting
Device
Alpha Neuron LLC (+5 Sites)Brainsway
Have you considered Trokendi Xr clinical trials? We made a collection of clinical trials featuring Trokendi Xr, we think they might fit your search criteria.Go to Trials
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