Johns Hopkins University clinical trial failures

Phase II Opioid Use Disorder trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

This study was de-prioritized in favor of the similar BIPOD-Out protocol due to a combination of practical considerations and expense. There are currently no plans to initiate this protocol.

Phase II Prostate Cancer trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

The sponsor was unable to produce and provide the study material (stravix)

Phase II COVID-19 trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The study was terminated due to insufficient participant enrollment resulting from a lower-than-expected number of COVID-19 cases

Early Phase I Healthy trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

The investigators are revisiting in vitro and in vivo studies to ensure the ability to replicate the results of the original paper before proceeding to the pilot clinical study.

Early Phase I Healthy Volunteers trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

The lead investigator moved institutions and the study will not continue upon his departure.

Unknown Chronic Low Back Pain trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Change in protocol per FDA that required funding and logistics that could not be accommodated.

Phase II COVID-19 trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

IRB00247544 is lapsed. Separate application submitted for reactivation under IRB00521868. Awaiting review \& approval

Phase II PTSD - Post Traumatic Stress Disorder trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study is being conducted externally.

Phase IV Opioid Overdose trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Currently does not have active IRB status

Phase I Amyotrophic Lateral Sclerosis trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

study stopped to enhance protocol and resume under different sponsor

Phase IV CLABSI - Central Line Associated Bloodstream Infection trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Subject recruitment was challenging

Phase I Healthy trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Unable to recruit participants.

Phase I Peritoneal Carcinomatosis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left institution

Unknown ROHHAD Syndrome trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Inadequate accrual

Phase IV ADHD trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study withdrawn in IRB by PI

Phase IV Dry Eye trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.

Phase I Amblyopia trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Hopkins failed to review contract with company providing complimentary dha, support was withdrawn necessitating me to get more grant money to fund study which was unsucccessful.

Phase II Opioid Use Disorder trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Lack of funding

Phase I Post-Traumatic Stress Disorder trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

The principal investigator will be at a new institution.

Phase IV Neuritis trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study has been halted prematurely

Phase III Urologic Diseases trial by Johns Hopkins University. Stop reason: EFFICACY/FUTILITY.

Met futility threshold at interim analysis

Early Phase I Tobacco Use Cessation trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

No Enrollees

Phase II Aging trial by Johns Hopkins University. Stop reason: OPERATIONAL.

For administrative reasons, we started a new study

Phase IV Type 2 Diabetes Mellitus trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

No sufficient numbers of eligible participants

Early Phase I Tourette Syndrome trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Low enrollment

Phase II COVID-19 trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Lack of recruitment

Phase II Multiple Sclerosis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The funding source decided to stop funding the study.

Phase I Myocardial Stunning trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Withdrawn in IRB.

Phase II Sars-CoV-2 Infection trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Single center study with low enrollment

Phase I Breast Cancer trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Drugs/devices discontinued

Phase I Pregnancy trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Study was not funded

Phase II Peanut Allergy trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Withdrawn in IRB

Phase I Bacterial Vaginosis trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Replaced with different study at another site.

Early Phase I Microtia trial by Johns Hopkins University. Stop reason: OPERATIONAL.

funding , recruitment issues

Phase III Cesarean Section Complications trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Withdrawn by IRB

Phase II Atrial Fibrillation trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Lack of faculty staffing

Early Phase I Chronic Pancreatitis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The FDA requirements for the IND are not feasible to complete.

Phase I HIV Dementia trial by Johns Hopkins University. Stop reason: SAFETY.

On 3/15/2020 study visits were suspended due to COVID-19 pandemic. With safety concerns surrounding COVID-19 and difficulty recruiting, the investigators decided to close enrollment 10/16/2020 after interim data were reviewed by the DSMB and NIH.

Phase III Fetal Growth Restriction trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

We are modifying this trial's protocol and will resubmit a new application at a later date.

Phase II Degeneration Disc Intervertebral trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Inability to obtain drugs from supplier.

Unknown Cirrhosis, Coagulopathy trial by Johns Hopkins University. Stop reason: OPERATIONAL.

No funding source available which was required for IRB approval

Phase I Extracorporeal Membrane Oxygenation Complication trial by Johns Hopkins University. Stop reason: OPERATIONAL.

unable to secure funding

Phase IV Cystic Fibrosis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Administrative delay

Phase I Schizophrenia trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Lack of funding

Unknown Low Bone Density trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Inability to analyze collected samples due to no funds.

Phase IV Prostate Cancer trial by Johns Hopkins University. Stop reason: EFFICACY/FUTILITY.

Early stopping point based on 2nd interim analysis (planned per protocol)

Early Phase I Uterine Atony trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Collaborators left the institution.

Phase II Thyroid Eye Disease trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Poor enrollment

Phase I Nasopharyngeal Carcinoma trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU and is not able to be reached for updates

Phase II Nasopharyngeal Carcinoma trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU and is not able to be reached for updates

Phase III Postoperative Pain trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Poor accrual due to change in standard of care procedure.

Phase IV Anxiety Disorders trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Funding cycle completed

Phase I Bladder Exstrophy trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Due to participants withdrawal prior to anticipated end of study.

Phase I Muscle Weakness trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Slow recruitment of eligible patients

Early Phase I Myasthenia Gravis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Mutual decision of sponsor and investigator due to logistical challenges

Unknown Dysphagia trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase IV Reversible Cerebral Vasoconstriction Syndrome trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Failure to recruit patients meeting inclusion criteria.

Unknown IDA in the Post-bariatric Surgical Patient trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study wasn't started.

Unknown Cataract trial by Johns Hopkins University. Stop reason: OPERATIONAL.

insufficient patient recruitment

Phase I Parkinson Disease trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Unable to recruit required participants

Phase I Healthy Volunteers trial by Johns Hopkins University. Stop reason: OPERATIONAL.

cancellation of funding contract

Unknown Interstitial Cystitis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Preliminary results were promising when interim analysis performed but terminated due to primary investigators left recruitment site.

Phase IV Adrenal Insufficiency trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Change in personnel leading to inability to conduct study.

Phase IV Acute Pain trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Funding withdrawn - slow enrollment

Early Phase I Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot) trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Sponsor decision - sponsor will be initiating a phase 3 mid-2019

Phase I Cardiac Surgery-CABG trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Loss of funding

Phase I Burn Any Degree Involving 20-29 Percent of Body Surface trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Intervention appeared to be associated with increased nausea in some patients.

Phase II Relapsing Remitting Multiple Sclerosis trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study revised to retrospective chart review

Phase I Anorexia Nervosa trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The study was withdrawn after 18 months due to lack of recruitment.

Phase I Crohn's Disease trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Too difficult to recruit given new Crohn's medications approved

Phase II Cigarette Smoking trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Inability to adequately recruit participants during pre-post operative period.

Phase I Peanut Allergy trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study product manufacturing suspended due to manufacturing problems, before initiation of study intervention.

Phase IV Drug Interaction trial by Johns Hopkins University. Stop reason: OPERATIONAL.

loss of funding

Phase IV Acute Coronary Syndrome trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Lack of funds for specimen management and data analysis

Phase IV Bariatric Surgery Candidate trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Recruitment trouble

Phase I Cirrhosis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI transferred from Georgetown to Johns Hopkins University. No participants enrolled at either site. Funding lapsed.

Phase IV Neonatal Post-Hemorrhagic Hydrocephalus trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

PI is leaving the institution

Unknown Intraoperative Cystoscopy trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Limited interest from colleagues/time constraints

Phase I Second Trimester Labor Induction trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Mycobacterium Tuberculosis trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Intracerebral Hemorrhage trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Poor recruitment, trial terminated

Unknown Diabetes trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

All investigators/co-investigators relocating to other institutions.

Phase IV Asthma trial by Johns Hopkins University. Stop reason: OPERATIONAL.

by sponsor due to failure to recruit patients who had mild persistent asthma who were not already on Advair 250/50 or 500/50.

Phase II Neonatal Abstinence Syndrome trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

The study was treminated because of low accural

Unknown Diabetes trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Delayed recruitment, funding exhausted

Phase IV Patients With Nasal Polyps trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline)

Phase II Diabetic Macular Edema trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Patient's disease progressed and Vision Dropped which led to exit from the study

Phase II Asthma trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left institution

Phase IV Diabetic Macular Edema trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The study was withdrawn due to difficult recruitment of patients for the study; No participants were enrolled in the study.

Phase II Isolated Systolic Hypertension trial by Johns Hopkins University. Stop reason: OPERATIONAL.

We were unable to recruit any subjects into this study so no subjects completed the protocol. Therefore, we are unable to provide any conclusions.

Phase IV Hypertension trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Slow enrollment

Phase IV Dementia trial by Johns Hopkins University. Stop reason: OPERATIONAL.

No funding and exclusion criteria were to stringent.

Unknown Autism trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Sponsor withdrew funds

Phase II CABG trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU

Phase II Diabetes Mellitus, Type 1 trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU

Phase II Glucose Homeostasis trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU

Phase II Bariatric Surgery trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU

Phase II Critically Ill trial by Johns Hopkins University. Stop reason: OPERATIONAL.

PI left JHU

Unknown Type 1 Diabetes trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

PI deceased

Phase II Headaches Associated With Subarachnoid Hemorrhage (SAH) trial by Johns Hopkins University. Stop reason: OPERATIONAL.

Inclusion criteria were too strict and therefore we were not able to recruit more patients.