Systematically Testing the Evidence on Marijuana

The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

First Posted: December 14, 2006

Condition(s): Emergency Contraception

Intervention(s): CDB-2914

Status: Completed

Enrollment (expected or actual): 1623

Allocation: N/A

Sponsor: HRA Pharma

Principal Investigator:

Completion Date (primary or actual): April 8, 2008

CT.gov Identifier: NCT00411684

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741. ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

First Posted: May 7, 2020

Condition(s): Parkinson's Disease (PD)

Intervention(s): ABBV-951

Status: Active, not recruiting

Enrollment (expected or actual): 130

Allocation: N/A

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): June 27, 2025

CT.gov Identifier: NCT04379050

This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.

First Posted: July 27, 2012

Condition(s): SCID, Omenn's Syndrome, Reticular Dysgenesis, Wiskott-Aldrich Syndrome, Bare Lymphocyte Syndrome, Common Variable Immunodeficiency, Chronic Granulomatous Disease, CD40 Ligand Deficiency, Hyper IgM Syndrome, X-linked Lymphoproliferative Disease, Hemophagocytic Lymphohistiocytosis, Griscelli Syndrome, Chediak-Higashi Syndrome, Langerhan's Cell Histiocytosis

Intervention(s): Alemtuzumab 0.3 mg, Cyclophosphamide, Busulfan, Stem Cell Transplantation, Fludarabine phosphate 40 mg, Melphalan, Alemtuzumab 0.2 mg, Busulfan, Fludarabine phosphate 30 mg, MESNA

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: Non-Randomized

Sponsor: Masonic Cancer Center, University of Minnesota

Principal Investigator:

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT01652092

GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.

First Posted: May 10, 2021

Condition(s): Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases

Intervention(s): GFB-024, Placebo

Status: Completed

Enrollment (expected or actual): 39

Allocation: Randomized

Sponsor: Goldfinch Bio, Inc.

Principal Investigator:

Completion Date (primary or actual): February 8, 2022

CT.gov Identifier: NCT04880291

This research is being done to evaluate whether combining medications that are FDA approved but have not yet been approved for combination treatment, can be an effective way to reduce pain. This is study 2 is a series of studies.

First Posted: July 30, 2019

Condition(s): Pain

Intervention(s): Within-subject test of blinded study medications

Status: Completed

Enrollment (expected or actual): 33

Allocation: N/A

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): November 1, 2022

CT.gov Identifier: NCT04036968

To identify factors and triggers influencing physical activity (PA) participation after structured cardiac rehabilitation (CR) among older adults who have enrolled in a center-based CR program, and compare the effects of a targeted health coaching intervention versus standard care immediately following structured CR on PA maintenance and functional fitness.

First Posted: March 17, 2023

Condition(s): Cardiac Rehabilitation, Health Coaching, Physical Activity

Intervention(s): Targeted Health Coaching Group, Standard Care Group

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Duke University

Principal Investigator:

Completion Date (primary or actual): June 1, 2024

CT.gov Identifier: NCT05773287

The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects. The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing. The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(*) and healthy controls (N = 60). (*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by NIDA to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.

First Posted: September 21, 2018

Condition(s): Low Back Pain, Recurrent, Healthy

Intervention(s): Within-Subject test of blinded study medication

Status: Recruiting

Enrollment (expected or actual): 250

Allocation: Non-Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): February 29, 2024

CT.gov Identifier: NCT03680287

Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because these diseases involve distinct pathophysiological processes, they require different specific care and treatment. In consequence, it is very important to improve our knowledge about HS in order to identify its mechanism and improve the diagnosis.

First Posted: October 15, 2015

Condition(s): Patients With Cognitive Disturbances

Intervention(s): Neurological examinations, Neuropsychological examinations, Clinical examinations, MRI 3T, MRI 7T

Status: Recruiting

Enrollment (expected or actual): 140

Allocation: Non-Randomized

Sponsor: Centre Hospitalier St Anne

Principal Investigator:

Completion Date (primary or actual): January 2020

CT.gov Identifier: NCT02576821

The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.

First Posted: April 8, 2021

Condition(s): Cirrhotic Ascites

Intervention(s): OrsHSA, HSA

Status: Recruiting

Enrollment (expected or actual): 220

Allocation: Randomized

Sponsor: Healthgen Biotechnology Corp.

Principal Investigator:

Completion Date (primary or actual): June 30, 2022

CT.gov Identifier: NCT04835480

A first-in-human study using TT-816 as a single agent and in combination with a PD-1 inhibitor in advanced cancers.

First Posted: September 1, 2022

Condition(s): Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology

Intervention(s): TT-816, A PD-1 inhibitor

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Non-Randomized

Sponsor: Teon Therapeutics, Inc.

Principal Investigator:

Completion Date (primary or actual): August 19, 2023

CT.gov Identifier: NCT05525455

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (> 10 years) with Irritable bowel syndrome (IBS)

First Posted: May 22, 2023

Condition(s): Irritable Bowel Syndrome

Intervention(s): palmithoylethanolamide/polydatin, placebo

Status: Recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: University of Roma La Sapienza

Principal Investigator: Prof. Giovanni Di Nardo, Professor

Completion Date (primary or actual): October 19, 2023

CT.gov Identifier: NCT05867693

This research is an experimental study with a randomized pre-test-post-test control group to evaluate the effect of the cognitive behavioral approach-based stress coping skills training program carried out by tele-nursing on the palliative care nurses' perception of stress, resilience and compassion fatigue. The main questions it aims to answer are: Question 1. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the increase in the stress coping score of the palliative care nurses in the intervention group? Question 2. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of stress perception among palliative care nurses in the intervention group? Question 3. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an impact on the increase in resilience of palliative care nurses in the intervention group? Question 4. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of compassion fatigue in palliative care nurses in the intervention group? The research was planned as a randomized controlled experimental design with the required ethics committee and institution permissions, a three-month announcement and initiation period, and an eight-week intervention period. Data will be collected twice at baseline and after intervention (Week 9). Personal information form, Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees will be used in the pre-test phase of data collection. Participants meeting the inclusion criteria will be assigned to the intervention and control groups by randomization. In order to support nurses in the intervention group to gain awareness of stress and anxiety and develop positive coping skills with stress, a total of 8 sessions of 40 minutes are planned, including interaction steps based on education and cognitive approach. Individuals will be given homework from the second week and they will be asked to deliver these homeworks to the researcher 2 days before the next interview, and it is planned to send reminder messages from the WastApp group created. Participants who do not deliver the assignments given in this study to the researcher on time will be excluded from the research even if they participate in online training. No intervention will be applied to individuals assigned to the control group. Participants will be informed about the Mobile Mental Health Support System created by the Turkish Ministry of Health and will be directed to this application. It is planned to apply Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees at the 9th week for the application of post-tests.

First Posted: April 26, 2023

Condition(s): Palliative Care Nurses

Intervention(s): Cognitive Behavioral Therapy, T.R. Mobile Mental Health Support System produced by the Ministry of Health

Status: Recruiting

Enrollment (expected or actual): 42

Allocation: Randomized

Sponsor: Eskisehir Osmangazi University

Principal Investigator: Ozge AYDOGAN ASIR, Principal İnvestigator

Completion Date (primary or actual): January 15, 2023

CT.gov Identifier: NCT05830448

Accurate patient information disclosure is critical to provide optimal treatment. Methods that can detect and then increase the truthfulness of information are relatively unknown. To investigate the impact of communication about privacy, benefits, and risk on patient truthfulness, the investigators test two new methods to detect patient truthfulness and demonstrate the effects of privacy notices (e.g. HIPPA statements). Participants include a national online sample randomly assigned to one of six treatment statements that might be typically given before health information was requested. The assigned treatments include one or mix of the following: privacy notice, statement of the benefits of accurate disclosure, and statement of the risks of inaccurate disclosure and control of no statement before being asked typical health questions. The investigators propose that based on elaboration likelihood model, statements reminding participants of their privacy will increase lying. The investigators hypothesis the use of a new biometric mouse movement lie detection method and answer adjustment can measure patient lies. The investigators hypothesis that reminders of the risk of not telling the truth will reduce lying due to risk aversion. Lastly the investigators hypothesis that statements of benefits of answering truthfully will increase truthfulness.

First Posted: March 17, 2021

Condition(s): Patient Lying, Privacy Statements, Risk Statements, Benefit Statements, Patient Lie Detection

Intervention(s): Benefit statement, Risk Statement, Privacy Statement, Benefit + Privacy, Risk + Privacy

Status: Completed

Enrollment (expected or actual): 619

Allocation: Randomized

Sponsor: University of Utah

Principal Investigator: Tamara Masters, PhD, Assistant Professor

Completion Date (primary or actual): April 19, 2020

CT.gov Identifier: NCT04803448

Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a study comparing the two catheter types in patients with periampullary diverticulum has not been performed, and there is no strong basis on which to recommend the balloon catheter as a first-line stone removal device. The investigators therefore conducted a multicenter prospective randomized trial to compare catheter performance in patients with periampullary diverticulum.

First Posted: September 21, 2016

Condition(s): Biliary Calculi

Intervention(s): Balloon catheter, Basket catheter

Status: Completed

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Anhui Provincial Hospital

Principal Investigator:

Completion Date (primary or actual): November 2016

CT.gov Identifier: NCT02909595

Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.

First Posted: December 30, 2013

Condition(s): Selective Cannulation Rate of Trainees Receiving ERCP Training

Intervention(s): Hands-on EMS training, Standard training

Status: Suspended

Enrollment (expected or actual): 400

Allocation: Randomized

Sponsor: Air Force Military Medical University, China

Principal Investigator: Yanglin Pan, Associated professor

Completion Date (primary or actual): December 2016

CT.gov Identifier: NCT02022605

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

First Posted: March 31, 2010

Condition(s): Parkinson's Disease

Intervention(s): IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, IPX066 245 mg

Status: Completed

Enrollment (expected or actual): 617

Allocation: N/A

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): October 2011

CT.gov Identifier: NCT01096186

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

First Posted: April 14, 2009

Condition(s): Parkinson's Disease

Intervention(s): Placebo, IPX066 95 mg LD, IPX066 145 mg LD, IPX066 195 mg LD, IPX066 245 mg LD

Status: Completed

Enrollment (expected or actual): 381

Allocation: Randomized

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): October 2010

CT.gov Identifier: NCT00880620

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

First Posted: April 2, 2012

Condition(s): Parkinson's Disease

Intervention(s): BIA 9-1067, Entacapone, Placebo, Levodopa, Carbidopa, Benserazide

Status: Completed

Enrollment (expected or actual): 600

Allocation: Randomized

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): November 2013

CT.gov Identifier: NCT01568073

A significant number of patients with Parkinson's disease (PD) face motor fluctuations even after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an evolving therapeutic option in different neurodegenerative diseases. In this study, the investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS) in the OFF state in PD patients. The investigators will give stimulation via tPCS (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.

First Posted: August 13, 2019

Condition(s): Parkinson Disease

Intervention(s): Active tPCS, Sham tPCS, Levodopa tablet

Status: Not yet recruiting

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: Western University, Canada

Principal Investigator: Mandar Jog, Professor

Completion Date (primary or actual): September 2021

CT.gov Identifier: NCT04054960

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

First Posted: March 16, 2021

Condition(s): Pancreatitis, Cholangitis, Cholecystitis; Gallstone, Jaundice, Obstructive

Intervention(s): LCBDE + LC, ERC + LC

Status: Not yet recruiting

Enrollment (expected or actual): 150

Allocation: Randomized

Sponsor: Lars Tue Sorensen

Principal Investigator: Lars Tue Sorensen, Dr. med. et pharm.

Completion Date (primary or actual): October 1, 2022

CT.gov Identifier: NCT04801238

The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

First Posted: December 22, 2020

Condition(s): PSP, CBD, PCA, LPA, Semantic Dementia, Semantic Aphasia, Behavioral Variant of Frontotemporal Dementia, FTD, PPA, Apraxia of Speech, MSA - Multiple System Atrophy, Parkinson Disease

Intervention(s): C-11 PiB, AV1451 Tau, C-11 ER176

Status: Enrolling by invitation

Enrollment (expected or actual): 500

Allocation:

Sponsor: Mayo Clinic

Principal Investigator: Keith A. Josephs, Professor of Neurology

Completion Date (primary or actual): November 2050

CT.gov Identifier: NCT04680130

To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.

First Posted: July 20, 2016

Condition(s): Hands-on Training

Intervention(s): ERCP Mechanical Simulator (EMS)

Status: Completed

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Principal Investigator:

Completion Date (primary or actual): December 26, 2018

CT.gov Identifier: NCT02838498

The aim of the planned research is to assess the dynamics of changes in the elements of the gut-brain axis (GBA), the cytokine profile and the endocannabinoid system markers, after dietary supplementation with probiotics Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 by professional dancers. Although in recent years there has been growing interest in the influence of the gut microbiota on the body's adaptation to stress stimuli and on overall health, there is a lack of information on the influence of probiotics on systems involved in maintaining neuropsychiatric balance, such as the endocannabinoid system. In order to determine the validity of the applied therapy with selective probiotics, the following will be assessed: intestinal bacteria and bacterial metabolites in the stool, cannabinoids and cannabinoid receptors and enzymes in the blood, indicators of mental distress in the blood, cytokines responsible for the modulation of the gut-brain axis in the blood, as well as questionnaires regarding the functioning of the digestive tract, fatigue, stress and sleep quality. The study will involve active dancers of the Polish Theater in Poznan, the Polish Dance Theater, the Private School of Dance Art in Poznan and students of the Academy of Physical Education in the field of Dance. Dancers are a group of athletes that is exposed to particular injuries and work-overload. Professional dancers spend multiple hours a week on intensive physical training. The largest percentage of injuries occurring in the group of professional dancers are chronic injuries, including: inflammation of soft tissues, muscle strains and tears. Professional dance is one of the most physically demanding forms of physical activity, and at the same time it is associated with a high burden on the nervous system problems caused by performances in front of an audience or subjective jury, frequent traveling and disturbances in the circadian rhythm.

First Posted: October 5, 2022

Condition(s): Fatigue, Stress, Job

Intervention(s): Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress), Starch (placebo)

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Poznan University of Physical Education

Principal Investigator: Jakub Wiącek, Principal Investigator

Completion Date (primary or actual): October 2022

CT.gov Identifier: NCT05567653

As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also be sought.

First Posted: December 2, 2011

Condition(s): Spinal Cord Injury

Intervention(s): SPINALON (buspirone + levodopa + cardidopa)

Status: Completed

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Nordic Life Science Pipeline Inc.

Principal Investigator:

Completion Date (primary or actual): August 2015

CT.gov Identifier: NCT01484184

The aim of this study is to increase norepinephrine levels in a population of young adults where NE levels are very low or undetectable. In order to achieve this, the optimal dose will be determined in a titration step. In the titration step, different doses of L-DOPS will be tested in order to find the optimal and safest dose suitable for each individual enrolled in the study. Because L-DOPS has never been used in the US in children or young adults, with this titration step investigators will also determine the safest dose for this population. Currently, L-DOPS is being used in our center to treat othostatic hypotension in autonomic failure. The titration step for this study starts with the dose of 100 mg and increases in an escalating manner up to a maximum of 600 mg a day (see investigational brochure attached). L-DOPS has been developed in capsules for oral used and all the previous safety data has been performed using this route. Oral route is the one that will used during study. Carbidopa is well tolerated, safe in children and it has been used in this population in the US without severe adverse effects.

First Posted: December 8, 2015

Condition(s): HSAN Type IV

Intervention(s): Droxidopa (L-DOPS), Placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): January 2019

CT.gov Identifier: NCT02624310