Dallas-based Cedar Health Research is enrolling local patients in two pediatric studies to expand the safe and effective treatment options for children with migraines. Cedar Health Research partners with physicians, like me, in the Dallas/Fort Worth Metroplex and across Texas to expand patient opportunities in clinical trial participation.

Migraine headache is a common childhood problem affecting up to 10% of children age 5-15 and up to 28% of teenagers. When simple measures do not ease the pain, some children require migraine relief medication such as acetaminophen or ibuprofen. Despite these treatments, many children still suffer excruciating pain and require prescription medication. The good news is approximately 25% of children will outgrow migraines by the age of 25. Until then, parents are searching for options to help.

Many drugs approved for adults have not been tested in children resulting in “off-label” use. The Food and Drug Administration initiated a pediatric program to allow well-controlled clinical trials to test the safety and efficacy of adult-approved medication in children.

Parents may find more effective migraine therapy options by enrolling a child in one of these clinical trials.

Headaches in Children

There are two common types of headaches that affect children. A pediatrician or pediatric neurologist will assess a child with recurrent headaches to determine the cause based on a series of diagnostic criteria.

1.Tension headaches. Tension-type headaches cause pain, pressure, or tightness on both sides of the head. The pain can be severe but usually does not interfere with daily activities.

2. Migraine headaches. Migraine headaches often start on one side and get worse over time. Children often have other accompanying symptoms like nausea, light sensitivity, dizziness, or visual changes. Other symptoms include mood changes, fatigue, anxiety, concentration problems, food cravings, neck stiffness, and hyperactivity. The pain can become progressively worse and keep the child from daily activities.

A doctor will help parents and children learn to recognize migraine signs and teach preventative and management steps.

The goal of migraine treatment is to find safe and effective pain relief to help the child return to normal functions as soon as possible. Headache calendars can help identify triggers that lead to migraines. Early interventions, such as taking a nap or resting in a dark room, may help prevent headaches. Lifestyle modifications like stress reduction, improving sleep habits, and dietary changes may help some children.

When these remedies are not effective, doctors will recommend over-the-counter medications such as acetaminophen and nonsteroidal anti-inflammatory drugs like ibuprofen and naproxen. For patients who continue to suffer from migraines, doctors may prescribe FDA-approved medications such as zolmitriptan and sumatriptan.

Rimegepant; A new option for pediatric migraines

Cedar Health Research, located in Dallas and Irving, is currently enrolling candidates in two clinical trials to evaluate the safety and tolerability of Rimegepant in children aged 6-18 with a history of migraines. Rimegepant, from Biohaven Pharmaceuticals, is an FDA-approved medication for adults for the acute treatment of Migraines.

Rimegepant helps adult patients find migraine relief by reducing calcitonin gene-related peptide (CGRP) induced symptoms. The drug’s mechanism of action blocks exaggerated pain signaling, inhibits blood vessel dilation, and reduces inflammation. Although Rimegepant is currently FDA-approved for adults, clinical trials are needed to determine children’s safety and efficacy. 

Phase 1 trial

The phase one clinical trial evaluates the pharmacokinetics of Rimegepant to determine the appropriate weight-based dosing regimen. Participants receive one dose of medication, and then blood samples are performed at four intervals after dosing. This allows scientists to track the body’s absorption of the medicine.

All qualifying candidates will receive the medication and are compensated for their participation.

Candidates must meet eligibility criteria, including:

• Age 6-12 years old
• Weight greater than 15 kg (33 lbs)
• Participants must be able to read and comprehend written instructions
• Participants must have a medically documented 6-month history of migraines
• A qualifying score on the Sheehan Suicidality Tracking Scale (S-STS)
• Must be able to be tolerate blood draws

Phase 3 trial

The phase three trial is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Rimegepant for treating migraines in children age 6-18 years old. This study aims to test how well the study drug works in children compared to a placebo. Up to 1440 participants will undergo evaluation during a 19-week timeline to treat up to two migraines of moderate to severe intensity.

All qualifying candidates will be randomly assigned to receive the medication or placebo and are compensated for their participation. 

Candidates must meet eligibility criteria including:

• Age 12 and 18 years old.
• Participants must experience at least one migraine a month.
• Participants must have a history of migraines for at least 6 months.

Learn more about the FDA Clinical trial process here in this video from theFood and Drug Administration.

Disclosure: The author serves as a principal investigator and sub-investigator in Women’s health studies through Cedar Health Research.

The post Dallas Researchers Recruiting for Pediatric Migraine Clinical Trial appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Endometriosis

Study Details

Fight Back Against Endometriosis

Endometriosis can be a pain, literally. If you are a woman between the ages of 18-49, experiencing symptoms of endometriosis, including painful periods and cramps, heavy bleeding, pain during intercourse, and infertility, clinical trials may be an option for you. Find out more today.

Participants may: 

• Have access to new investigational options
• See a physician or medical staff at no cost
• Receive compensation for time and travel

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Endometriosis Clinical Study Participants – Women’s Health appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Migraine – Pain Management

Study Details

Struggling with Migraines?

Migraine headaches are characterized by throbbing in one particular area of the head and can vary from moderate to severe intensity. If you or someone you love suffers from migration headaches, research studies could provide you with treatment options. Those who qualify have access to a licensed physician and compensation for time and travel expenses.

Learn more today!

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Migraine Clinical Study Participants – Men and Women appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Pediatric Migraine

Study Details

Migraines should be the least of their worries.

Migraines are characterized by throbbing pain in one or both areas of the head that can vary from moderate to severe intensity. Common symptoms include nausea, vomiting, sensitivity to light and sound. If your child is experiencing migraines, research studies could be an option.Children that qualify may:

• See a doctor or medical staff at no cost
• Have access to trial medication

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Pediatric Migraine Clinical Study Participants – Children appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Hot Flashes

Study Details

Hot flashes are overwhelming

Hot flashes often occur during menopause; they can leave you feeling unbearably warm and sweaty. Common symptoms associated with hot flashes include a sudden feeling of warmth that spreads throughout your face, chest, and neck leaving a flushed appearance, rapid heartbeat, and perspiration. Researchers at Cedar Health are seeking women who are experiencing hot flash symptoms to participate in upcoming research studies. Find out more!

Qualified participants include:

• Females who are experiencing symptoms of hot flashes

Additional criteria apply.

Qualified participants may see a physician or medical staff at no cost and receive reasonable compensation for study-related time and travel.

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Hot Flashes Clinical Study Participants – Women’s Health appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Birth Control

Study Details

You Body, Your Birth Control Options

Research studies evaluating potential new birth control options are enrolling now. Healthy, sexually active adult females may qualify to participate at no cost, no insurance required.

Qualified participants may receive:

• Access to potential new birth control options at no cost, no insurance required.
• Compensation for study-related time and travel.

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Birth Control Clinical Study Participants – Women’s Health appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Vaccine

Study Details

Vaccines Save Lives

Vaccines have played a huge role in eradicating many serious conditions and have reduced our risk of contracting others. Local doctors are seeking healthy participants to take part in upcoming vaccine clinical trials. Find out how you can get involved in these important trial opportunities today.

Qualified participants may:

• See  doctor or medical staff at no cost
• Have access to trial vaccines
• Receive compensation for time and travel

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Vaccine Clinical Study Participants – Men and Women appeared first on Medika Life.