ABP-450 for Migraine

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Renstar Medical Research, Ocala, FL
Migraine+1 More
ABP-450 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a drug called ABP-450 can prevent migraines.

See full description

Eligible Conditions

  • Migraine

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Migraine

Study Objectives

This trial is evaluating whether ABP-450 will improve 2 primary outcomes, 6 secondary outcomes, and 6 other outcomes in patients with Migraine. Measurement will happen over the course of Baseline to Week 48 - End of Treatment Period.

Week 48
Change in Monthly Migraine Days
Week 52
Development of Anti-Drug Antibodies (ADA) to ABP-450
Incidence of Treatment Emergent Adverse Events
Mean Change in Migraine Disability Assessment Score (MIDAS) Total Score
Mean Change in Monthly Headache Days
Mean Change in Patient Global Impression of Change (PGI-C) Score
Mean Change in Patient Global Impression of Severity (PGI-S) Score
Mean change in Headache Hours
Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches
Percentage of Patients with Reduction in Mean Migraine Days (MMD)
Percentage of Patients with Reduction in Migraine Physical Function Impact Diary (MPFID)
Percentage of Patients with Reduction in the Physical Impairment Domaine Score of the Migraine Physical Function Impact Diary (MPFID)
Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
Month 12
Mean change of Migraine-Specific-Quality of Life (MSQ) Domains

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Migraine

Trial Design

2 Treatment Groups

ABP-450 - Low Dose
1 of 2
ABP-450 - High Dose
1 of 2
Experimental Treatment

This trial requires 690 total participants across 2 different treatment groups

This trial involves 2 different treatments. ABP-450 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

ABP-450 - Low Dose
Drug
ABP-450 Low Dose - intramuscular injections into specified muscles.
ABP-450 - High Dose
Drug
ABP-450 High Dose - intramuscular injections into specified muscles

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 12 months for reporting.

Closest Location

Renstar Medical Research - Ocala, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient can understand the ICF, provides signed ICF and patient privacy information (eg, Authorization for Use and Release of Health and Research Study Information) before initiating any study-specific procedure, and agrees to comply with protocol requirements.
Patient was enrolled in Study ABP-20001 and successfully completed that study's treatment and procedures.
A WOCBP must be willing and able to use a medically acceptable and effective method of birth control, as determined by the investigator, during the entire study (Appendix 13.3).
A WOCBP (Appendix 13.3) must have a negative urine pregnancy test at Visit 1.
Patient can read, understand, and complete the eDiary.
Patient is willing and able to adhere to the study assessments, visit schedules, and prohibitions, as described in this protocol.

Patient Q&A Section

What is sick headache?

"Sick headache is a neurological disorder commonly experienced by the pediatric population. Children with sick headache might be more likely to have an underlying neurological or systemic condition. As a neurologist, this condition must be thoroughly and appropriately evaluated." - Anonymous Online Contributor

Unverified Answer

Can sick headache be cured?

"A number of potential patients will not experience satisfactory outcomes (the ‘sick headache clinic’). Despite these limitations, the treatment has a long record of success, with over 80% experiencing at least substantial improvement, and a low rate of recurrence. There is also an important and growing group of patients who fail to make gains, and who continue to experience significant symptoms. These can be targeted for more sophisticated treatment regimes and, in their absence, the treatment program will continue to offer benefit." - Anonymous Online Contributor

Unverified Answer

What are the signs of sick headache?

"The headache is a common symptom of migraine and is one of two main reasons for visit to the hospital, and accordingly is a main reason for the hospitalisation. An additional reason for hospitalisation is a persistent headache that persists for at least 1 week and that consists of moderate to severe pain associated with nausea or visual disturbance. The headache is a main reason for disability." - Anonymous Online Contributor

Unverified Answer

What causes sick headache?

"Acute sick headache is the most common headache, especially in students while studying for exams. Many factors influence its occurrence. A significant prevalence of familial or hereditary factors has been reported." - Anonymous Online Contributor

Unverified Answer

How many people get sick headache a year in the United States?

"Around 90% of American adults have at least one episode of head or neck symptom in any given year. On an annual basis, around 16 million American citizens have a head or neck complaint. As for those with headache complaints, approximately 2 million are diagnosed with migraine." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sick headache?

"There is no convincing evidence that medications improve the symptoms of sick headache in children. The most common treatments are analgesics, with less than 2% of children receiving medications for children with recurrent headache. These treatments do not impact the frequency or severity of pain." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets sick headache?

"It is important to find answers to the questions above. If you have sick headache but the answer to the question is “not sure,” talk with a health care professional." - Anonymous Online Contributor

Unverified Answer

Does abp-450 improve quality of life for those with sick headache?

"Abp-450 reduces pain and fatigue but does not improve functioning or QOL in patients with chronic sick headache over 3 months. The abdutrant is well tolerated, with most adverse reactions and discontinuations unrelated to the abdutrant and resulting in temporary withdrawal. This is the largest cohort study to assess the effects of abp-450 on pain and QOL in sick headache." - Anonymous Online Contributor

Unverified Answer

What does abp-450 usually treat?

"Abp-450 is a common drug prescribed for sick headaches. Many people have no idea what any form of over-the-counter medications are and why they are used; abp-450 is just one of the many. Since abp-450 is commonly used as a prescription medication and is generally prescribed to people with headaches, it is important to know all of the questions you have when you must take an abp-450 to get relief." - Anonymous Online Contributor

Unverified Answer

Has abp-450 proven to be more effective than a placebo?

"A phellodon is more effective than a placebo in the treatment of [migraine](https://www.withpower.com/clinical-trials/migraine). However, no statistically significant difference in response rate was found between ABP-450 and placebo." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating sick headache?

"There have not been any new discoveries for treating sick headache and only the introduction of analgesic medications with anti-inflammatory (such as ibuprofen) and anti-depressor (such as diazepam) actions." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sick headache?

"Despite many years of research and the discovery of several putative causes, the exact cause of sick headache remains unidentified. In this retrospective series, the most commonly described causes of sick headache were chronic headache, migraine, vascular headache, and systemic headache (i.e., headache with no identifiable origin)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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