CLINICAL TRIAL

Sildenafil Citrate for Brain Injuries

Recruiting · 18+ · Male · Philadelphia, PA

This study is evaluating whether a drug may help improve blood flow in the brain for individuals with a history of repetitive mild traumatic brain injury.

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About the trial for Brain Injuries

Eligible Conditions
Post-Concussion Syndrome · Mild Traumatic Brain Injury (MTBI) · Brain Injuries, Traumatic · Brain Injuries · Brain Concussion · Wounds and Injuries · Traumatic Brain Injury (TBI)

Treatment Groups

This trial involves 2 different treatments. Sildenafil Citrate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

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

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
FDA approved

Side Effect Profile for Sildenafil

Sildenafil
Show all side effects
Headache
14%
Oedema peripheral
14%
Diarrhoea
14%
Nasopharyngitis
10%
Flushing
10%
Bronchitis
10%
Vertigo
10%
Palpitations
10%
Respiratory tract infection
8%
Pulmonary hypertension
6%
Depression
6%
Vision blurred
6%
Presyncope
6%
Right ventricular failure
6%
Dyspnoea
6%
Upper respiratory tract infection
4%
Pulmonary arterial hypertension
4%
Bronchopneumonia
4%
Anaemia
4%
Cardiac failure
2%
Hypertension
2%
Hypoxia
2%
Walking distance test abnormal
2%
Nausea
2%
Gangrene
2%
Breast cancer
2%
Cardiovascular disorder
2%
Haemoptysis
2%
Sinusitis
2%
Haemoglobin decreased
2%
Acute coronary syndrome
2%
Chest discomfort
2%
General physical health deterioration
2%
Circulatory collapse
2%
Respiratory syncytial virus infection
2%
Uterine haemorrhage
2%
Back pain
2%
Skin ulcer
2%
Cough
2%
Urinary tract infection
2%
Pancreatic neoplasm
2%
Inguinal hernia
2%
Coronary artery disease
2%
Asthenia
2%
Death
2%
Mitral valve incompetence
2%
Adenocarcinoma of colon
0%
Post procedural haematoma
0%
Syncope
0%
Fluid retention
0%
Skin graft
0%
Gastritis viral
0%
Pain in extremity
0%
Chest pain
0%
Sciatica
0%
Musculoskeletal chest pain
0%
Contrast media allergy
0%
Abscess
0%
Erysipelas
0%
Osteomyelitis
0%
Paresis
0%
Pericardial effusion
0%
Fluid overload
0%
Abdominal pain
0%
Sepsis
0%
Pleural effusion
0%
Pneumonia
0%
Gastric cancer
0%
Weight increased
0%
Gout
0%
Arthralgia
0%
Mania
0%
Osteoporosis
0%
Rotator cuff syndrome
0%
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT00323297) in the Sildenafil ARM group. Side effects include: Headache with 14%, Oedema peripheral with 14%, Diarrhoea with 14%, Nasopharyngitis with 10%, Flushing with 10%.

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 40-65 years
Former National Football League (NFL) players or former varsity college football players
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 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 Sildenafil Citrate will improve 1 primary outcome, 2 secondary outcomes, and 10 other outcomes in patients with Brain Injuries. Measurement will happen over the course of 5 weeks.

Effect of 5 weeks of sildenafil treatment on language and memory using the Animal Fluency test.
5 WEEKS
To evaluate the effects of 5 weeks of treatment with sildenafil citrate on language and memory, measured using the Animal Fluency test.
Effect of 5 weeks of sildenafil treatment on executive function using the Controlled Oral Word Association Test (COWAT).
5 WEEKS
To evaluate the effects of 5 weeks of treatment with sildenafil citrate on executive function, measured using the Controlled Oral Word Association Test (COWAT).
Effect of 5 weeks of sildenafil treatment on attention using Trail Making Test Part A.
5 WEEKS
To evaluate the effects of 5 weeks of treatment with sildenafil citrate on attention, measured using the Trail Making Test Part A.
Effect of 5 weeks sildenafil treatment on CVR as measured by BOLD response to hypercapnia.
5 WEEKS
To evaluate the effects of 5 weeks of treatment on CVR by measuring BOLD signal in response to hypercapnia after 5 week treatment with sildenafil, compared to within-subject CVR response before sildenafil treatment.
Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.
IMMEDIATE
Determine if single dose treatment with sildenafil (60 mg orally) is effective in increasing the global BOLD response to hypercapnia (5% CO2).
Effect of single dose sildenafil citrate treatment on functional near-infrared spectroscopy (fNIRS) response to hypercapnia.
IMMEDIATE
Determine if single dose treatment with sildenafil (60 mg orally) is effective in increasing the functional near-infrared spectroscopy (fNIRS) response to hypercapnia (5% CO2).
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Who is running the study

Principal Investigator
R. D.
Prof. Ramon Diaz-Arrastia, Presidential Professor
University of Pennsylvania

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 causes brain injuries?

Brain injuries are common but hard to predict because they are often multifactorial and involve various mechanisms. Understanding the process of injury in a model system such as the rat will help in the search for therapeutic targets.

Anonymous Patient Answer

What are common treatments for brain injuries?

The most common treatments for brain injury (brain injuries resulting from trauma to the head or brain or from disease processes) were surgery, medical and/or procedural care, brain implants and/or medications, and rehabilitation. There were some unique types of therapy, such as speech and language therapy with the use of communication aids and other devices specifically designed to promote communication in individuals with brain deficits.

Anonymous Patient Answer

What are the signs of brain injuries?

A careful examination and a history can often help to decide what to do about an injured brain. Common signs of brain damage include loss of consciousness, an inability to move the eyes or to make the same movements repeatedly, and loss of memory and a loss of sense of personality.

Anonymous Patient Answer

Can brain injuries be cured?

Traumatic brain injury is a progressive, often fatal, disease process. Brain injuries cannot be cured. If injuries are sufficiently severe as to prevent normal mental ability, there is almost never any possibility of recovery. With appropriate immediate intervention, however, some head injury victims and their families can experience and often thrive on a life of normality with minimal or no noticeable symptoms or disabilities. With proper care, an injured person can return to normal function and, if the injury was mild, be able to return to normal life. For example, return to normal cognitive functioning is much more likely in those with mild traumatic brain injury than those with severe head trauma.

Anonymous Patient Answer

What is brain injuries?

In a recent study, findings, the prevalence of brain injuries among female victims of violence was 0.27%, while in male victims it was 0.20%. It was concluded that the high rate of brain injuries among male victims of violence could be attributed to the fact that males tend to get into armed and violent conflicts. Nevertheless, the prevalence of brain injuries among female victims of violence was relatively more than those of males.

Anonymous Patient Answer

How many people get brain injuries a year in the United States?

The findings indicate that [brain injury](https://www.withpower.com/clinical-trials/brain-injury) rates are higher than previously reported in the United States, when adjusted for the age of the patient. This may be due to increased attention of health care providers to the potential impact of brain injury.

Anonymous Patient Answer

Is sildenafil citrate typically used in combination with any other treatments?

Because no published data exist regarding the use of sildenafil with the use of anesthetic techniques in patients with brain damage after an anesthetic, this study is the only one in which it is reported to date.

Anonymous Patient Answer

Has sildenafil citrate proven to be more effective than a placebo?

Treatment of [traumatic brain injury](https://www.withpower.com/clinical-trials/traumatic-brain-injury) patients with sildenafil citrate was associated with a significant reduction in mortality, hospital stay, and ICU admissions without a negative effect on long-term outcomes.

Anonymous Patient Answer

How does sildenafil citrate work?

It is important to consider the mechanism of action of sildenafil citrate on the brain to help formulate new guidelines for its use with patients with brain injuries.

Anonymous Patient Answer

Does sildenafil citrate improve quality of life for those with brain injuries?

Men with TBI report a higher level of HRQOL compared with healthy controls, although sildenafil citrate did not significantly improve HRQOL when compared with placebo.

Anonymous Patient Answer

Who should consider clinical trials for brain injuries?

Most patients with brain injury would benefit from participation in a clinical trial. The most relevant subset of patients who would benefit from clinical trial participation include those with severe or disabling neurological deficits, who have not responded to medical therapy, or who are at risk for developing severe neurological deficits.

Anonymous Patient Answer

What are the common side effects of sildenafil citrate?

A common side effect of therapy with sildenafil citrate, when used appropriately, is dysgeusia"

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Anonymous Patient Answer
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