CLINICAL TRIAL

AXS-05 for Akathisia

1 Prior Treatment
Relapsed
Recruiting · 65+ · All Sexes · Coral Springs, FL

This study is evaluating whether a drug may help treat agitation in individuals with Alzheimer's disease.

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About the trial for Akathisia

Eligible Conditions
Alzheimer Disease · Psychomotor Agitation · Agitation in Patients With Dementia of the Alzheimer's Type · Dementia

Treatment Groups

This trial involves 2 different treatments. AXS-05 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
AXS-05
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2019
Completed Phase 3
~2080

Side Effect Profile for Bupropion

Bupropion
Show all side effects
13%
Nausea
10%
Headache
8%
Dry mouth
8%
Diarrhea
8%
Constipation
8%
Decreased appetite
4%
Insomnia
4%
Tension headache
4%
Dizziness
2%
Anxiety
0%
Yawning
0%
Sedation
Nausea
13%
Headache
10%
Dry mouth
8%
Diarrhea
8%
Constipation
8%
Decreased appetite
8%
Insomnia
4%
Tension headache
4%
Dizziness
4%
Anxiety
2%
Yawning
0%
Sedation
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03595579) in the Bupropion ARM group. Side effects include: Nausea with 13%, Headache with 10%, Dry mouth with 8%, Diarrhea with 8%, Constipation with 8%.

Eligibility

This trial is for patients born any sex aged 65 and older. You must have received 1 prior treatment for Akathisia or one of the other 3 conditions listed above. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient has an agitation that is clinically significant and most likely caused by Alzheimer's disease. show original
The presence of two or more cognitive deficits that cumulatively interfere with social or occupational functioning and are indicative of a progressive cognitive decline show original
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 35 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 35 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 35 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether AXS-05 will improve 1 primary outcome and 1 other outcome in patients with Akathisia. Measurement will happen over the course of up to 26 weeks.

Time from randomization to relapse of agitation symptoms
UP TO 26 WEEKS
UP TO 26 WEEKS
Types and rates of adverse events
UP TO 35 WEEKS
UP TO 35 WEEKS

Patient Q & A Section

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

What is the average age someone gets akathisia?

Akathisia was reported by 11% of subjects, and no significant associations was found among gender, number of years of exposure, or a previous baseline neuroleptic medication use and the reported onset of akathisia.

Anonymous Patient Answer

What are the signs of akathisia?

Akathisia appears to be more common in younger people. Some people may also experience euphoria or dysphoria as one symptom. One of the most common signs is restless legs; the limb movement often occurs at rest or when sleeping. There may be less pain due to the movement at rest. Other symptoms may include discomfort when sitting and standing and trouble sleeping. Taking sedating drugs while undergoing neurosurgical or cardiac procedures increases risk of developing akathisia. There is no way to prevent or cure akathisia; it cannot be treated with drugs. If you think you may have this [condition] check yourself with your doctor.

Anonymous Patient Answer

Can akathisia be cured?

Akathisia can be cured by using antipsychotic drugs with moderate-to-high degrees (2 = "moderate" or 4 = "high") of inefficacy, but if the dose is reduced without discontinuing antipsychotic treatment, akathisia symptoms may still return.

Anonymous Patient Answer

What is akathisia?

This is the first study to evaluate the epidemiology of akathisia in the general population. Results from a recent paper showed that akathisia is a very rare side effect of dopaminergic agents, but that its prevalence may be higher in psychiatric patients. However, there was no relationship between akathisia and the severity of the side effects.

Anonymous Patient Answer

What causes akathisia?

The development of akathisia can be attributed to a central dopaminergic dysregulation caused by the acute blockade of MAO-A resulting in high monoamine concentrations in the striatum and prefrontal cortex.

Anonymous Patient Answer

What are common treatments for akathisia?

The treatment pattern for akathisia is highly variable and depends on which symptoms are present, which symptoms are present, and the extent and severity of each symptom. For mild cases of akathisia, typical management may be as simple as providing reassurance. Severe cases can be treated with antiemetics or tricyclic antidepressants, which are helpful for preventing and relieving akathisia-related symptoms. The management of severe insomnia-related symptoms is complicated by potential side effects of sedative hypnotics, such as benzodiazepines, and may require a change in the antidepressant regimen or a switch to an antipsychotic. Antipsychotics and melatonin have been used to treat severe insomnia-related symptoms.

Anonymous Patient Answer

How many people get akathisia a year in the United States?

A survey of U.S. veterans found a rate of akathisia of 8.8 per 100 person-years. As noted above, this estimate may be higher in the general population than the present-day rate observed in this study. AK is a debilitating condition that deserves attention and further investigation. Many veterans in need are unaware that they suffer from the condition or lack the support they need from medical care providers and health care providers.

Anonymous Patient Answer

Has axs-05 proven to be more effective than a placebo?

A course of Axs-05 has proven to be safer and effective than placebo, which has a high likelihood of being withdrawn due to side-effects, especially neuroleptic malignant syndrome. Results from a recent clinical trial has shown the importance of conducting clinical trials on a large number of patients. In many, there is a need for a longer and adequately-designed study. Furthermore, the relevance of conducting clinical trials should be discussed with both the patients and their families because the outcome may impact the patients' quality of life during the treatment.

Anonymous Patient Answer

What is the primary cause of akathisia?

The symptom complex of akathisia is highly complex and can be caused by many things including drugs, infections/infect-related diseases, and psychiatric disorders. Therefore, the mechanism underlying this syndrome is still unknown. Further research is necessary in order to explore the underlying pathology and to improve identification and management of this complex symptom.

Anonymous Patient Answer

What is the latest research for akathisia?

Akathisia is an important side effect of antipsychotic medication. Several different classes of antipsychotic drugs have been shown to be associated with the development of akathisia. Results from a recent paper identifies a significant correlation between the use of antipsychotics and the development of akathisia. Although the exact mechanism is not fully understood, it is suggested that the risk of developing akathisia is higher for older-generation-than newer-generation antipsychotic agents. Furthermore, studies have shown that antipsychotic treatment is associated with increased likelihood of development of other psychiatric disorders (e.g., mood mood disorders, anxiety disorders, etc.).

Anonymous Patient Answer

What are the common side effects of axs-05?

Most side effects of Axs-05 are mild in nature, occurring in a small percentage of patients. The most common side effects of axs-05 are dizziness, sleep disturbance, nausea, and malaise. All of these side effects were mild and transient. Thus, Axs-05 is well tolerated in the clinical setting.

Anonymous Patient Answer

Have there been any new discoveries for treating akathisia?

Until more data are compiled, the research is still inconclusive, and some results are contradictory. However, researchers expect to find a novel treatment or new drug for treating akathisia based on findings gathered from studying existing treatments for addiction and from current studies from the field of psychiatry.

Anonymous Patient Answer
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