IMIC Research


​ medical research in Miami phase 1 research studies in Miami

​Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control


Eligibility

Ages Eligible for Study: 18 Years and older  
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Criteria

Inclusion Criteria:

  • Patients with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and <60 mL/min
  • Provide written informed consent
  • Willing and able to comply with all aspects of the protocol


Exclusion Criteria:

  • Hemoglobin A1c (HbA1c) of <7.0% or >11.0%
  • Type 1 diabetes.
  • Women who could become pregnant.
  • Treatment with an SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
  • Uncontrolled high blood pressure.
  • Severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes will result in a short life expectancy.

A 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease_ (MissionAD)


Eligibility

Ages Eligible for Study: 50 to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Criteria

Inclusion Criteria:

- Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including:Mini Mental State Examination score equal to or greater than 24; Clinical Dementia Rating (CDR) global score of 0.5 with CDR Memory Box score of 0.5 or greater
- Impaired episodic memory confirmed by a list learning task
- Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography (PET) or cerebrospinal fluid assessment or both
- Study partner able to support the participant for duration of the study

Exclusion Criteria:


Call for more information.

A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis Patients Who Are Naive to TNF Inhibitors


Eligibility

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study:  
Both
Accepts Healthy Volunteers:  
No


Criteria

Inclusion Criteria:

  • 18-80 years of age, inclusive
  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
  • Naive to treatment with any anti-TNF therapy
  • An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
  • Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
  • Use of highly effective contraception as defined by the protocol


Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
  • Prior or planned surgery for UC
  • Past or present ileostomy or colostomy
  • Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
  • Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)

Tourette syndrome

Research Patients Paid Research Studies

Diabetes Type 2

Patients are invited for participation in clinical trials. Every participant is compensated for their time and travel. There are various paid medical research studies.
Please call for current studies information or to enter into our database to be considered for future studies at
786-600-7005.


​Current enrolling studies ( as listed on clinicaltrials.gov): paid research studies in Miami

Non-Alcoholic Steatohepatitis (NASH) Fibrosis

Alzheimer's Disease

A Study of the Safety and Efficacy of Etrolizumab in Patients With Moderately to Severely Active Crohn's Disease


Eligibility

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • 18-80 years of age (inclusive)
  • Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
  • Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
  • Use of effective contraception as defined by the protocol


Exclusion Criteria:

  • A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
  • Planned surgery for CD
  • Ileostomy or colostomy
  • Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efilizumab, as stated in the protocol)
  • Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)

Agitation in Dementia

Crohn's Disease

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis


Eligibility

Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

  • Ulcerative Colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide


Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
  • History of uveitis macular edema
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening

Ulcerative Colitis

The purpose of this study is to evaluate the dose-response of different doses of CHF 781 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.


Eligibility

Ages Eligible for Study: 18 Years to 75 ​
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent form prior to initiation of any study-related procedure.
    - A diagnosis of asthma as defined in the GINA Report, 2016, documented for at least 1 year prior to screening.
    Subjects with poorly controlled or uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at randomization visits).
    -Subjects with a pre-bronchodilator FEV1 ≥50% and <85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits.
    -Subjects with a positive response to a reversibility test at screening (pre - post BD), within 1 year prior to or at screening defined as ΔFEV1≥12% and ≥200mL over baseline within 30 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation.
    -Use of inhaled corticosteroids (low/medium dose according to GINA Report 2016) with or without a LABD for 3 months (stable dose in the last 4 weeks) before screening visit
    -A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers.
    -A basal morning (7-10 am) serum cortisol level between 7-28 µg/dL at screening (V1).
    -A Body Mass Index: 18.5 ≤ BMI <35 kg/m2.

Exclusion Criteria:

  • Pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method
    Subjects who suffer from COPD as defined by the GOLD Report 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016.
    Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake.
    Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of >10 pack-years or having stopped smoking one year or less prior to screening visit.
    History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
    An asthma exacerbation requiring oral corticosteroids within 3 months or hospitalization within 6 months prior to screening.
    Subjects with unresolved bacterial or viral respiratory tract, sinus or middle ear infection affecting asthma status within 2 weeks prior to screening.
    Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
    Subjects with oral candidiasis at screening or at randomization.
    Subjects with any clinically significant, uncontrolled condition
    Subjects who have clinically significant cardiovascular condition
    Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement.
    Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450ms for males or QTcF >470ms for females at screening and randomization visits.
    Subjects with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
    Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polycolonal antibodies within 12 weeks prior to screening.
    Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.
    History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
    Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
    Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order.
    Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.minute) .-A history of myocardial infarction within 1 year of screening visit.-Unstable or life-threatening cardiac arrhythmia.-Hospitalization for heart failure within the past year.​

  • ​A history of significant alcohol or drug abuse
  • ​Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.

​Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type


Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
    -The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
    -The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
    -Either out patients or residents of an assisted-living facility or a skilled nursing home
    -Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
    -Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
    -Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
    -Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
    - Participant with myasthenia gravis

​Evaluation of SPN-812 ER Low Dose in Children With ADHD


Eligibility

Ages Eligible for Study:   6 Years to 11 Years   (Child) and 12 to 17
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Criteria

Inclusion Criteria:

- Healthy male or female subjects, 6-11 years of age, inclusive.
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM V), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
-Attention Deficit/Hyperactivity Disorder Rating Scale-V, Home Version: Child, Investigator Administered and Scored (ADHD-RS-V) score of at least 28.
-CGI-S score of at least 4 at screening.
Weight of at least 20 kg.
-Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study.
-Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram.
-Written informed consent obtained from the subject's parent or legal representative and informed assent from the subject, if applicable.
- Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the acceptable birth control methods beginning 30 days prior to the first dose.


Exclusion Criteria:

- Current diagnosis of major psychological disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months.
- Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study.
- Current diagnosis of significant systemic disease.
- Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening.
- BMI greater than 95th percentile for the appropriate age and gender.
- History of an allergic reaction to viloxazine or related drugs.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
- Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM.
- Any reason, which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Positive drug screen at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening; the subject will be required to discontinue the stimulant for the study, beginning at least one week prior to the Baseline Visit.
-Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential).

Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis (ENCORE-NF)


Eligibility

Ages Eligible for Study: 18 Years and older   (Adult, Senior)​
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Criteria

Inclusion Criteria:

  • Male or female subjects 18 years or older, able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
  • Histological evidence of definite NASH based on NASH CLinical Research Network (CRN) criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1
  • NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
  • Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System
  •   Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
  • If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy)


Exclusion Criteria:

  • Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator's judgement
  • Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, or systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses
  • Uncontrolled diabetes (HbA1c ≥9%) within 60 days prior to Day 1
  • Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading)
  • Hepatitis and fibrosis more likely related to etiologies other than NASH such as:


a - alcoholic steatohepatitis
b - autoimmune hepatitis
c - hepatitis B virus (HBV) infection
d - hepatitis C virus (HCV) infection
e - primary biliary cirrhosis
f - primary sclerosing cholangitis
g - Wilson's disease
h - alpha-1-antitrypsin deficiency
i - hemochromatosis or iron overload
j - drug-induced liver disease
k - other biliary liver disease

  • ALT or AST >5 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert's as documented in the medical records)
  • Alpha-fetoprotein >200 ng/mL
  • Hemoglobin <10 g/dL
  • White blood cell count <2.0 x 10^3/mm3
  • Estimated creatinine clearance <30 mL/min
  • Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications
  • Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
  • Inability to safely obtain a liver biopsy
  • Known human immunodeficiency virus (HIV) infection
  • Weight loss ≥ 10% within 6 months of Day 1
  • Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement
  • History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
  • Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening
  • History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval >480 milliseconds (msec)
  • Prior or planned (during the time frame of the study) bariatric surgery
  • If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
  • Previous treatment with emricasan or active investigational medication in a clinical trial within 6 months prior to Day 1
  • Prior liver transplant

Diabetes Type 2

No insurance is required ! 
Participants are compensated -

from $100 to $4000
Please call for more information.
IMIC Inc.
18320 Franjo Rd
Palmetto Bay, FL 33157
(786)600-7005, (786)310-7377, 
Fax 1305-252-2199, 786-536-9016
info@aktamedika.com
www.aktamedika.com

www.imicinc.com
Learn more about research studies here.
Thank you!

           ADHD

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis


Eligibility

Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

  • Ulcerative Colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide


Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
  • History of uveitis macular edema
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening

Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Criteria

Key Inclusion Criteria:

- Have a clinical diagnosis of Tourette Syndrome (TS)
- Have at least moderate tic severity
- Have TS symptoms that impair school, occupational, and/or social function
- If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
- Be in good general health
- Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study


Exclusion Criteria:

- Have an active, clinically significant unstable medical condition within 1 month prior to screening
- Have a known history of long QT syndrome or cardiac arrhythmia
-Have a known history of neuroleptic malignant syndrome
-Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
-Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
-Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
-Have a known history of substance dependence, substance (drug) or alcohol abuse
-Have a significant risk of suicidal or violent behavior
-Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
-Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study

Asthma


Ulcerative Colitis

Diabetes Type 2

Crohn's Disease