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Trial record 22 of 326 for:    clonidine

Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies (a2a Agonist)

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ClinicalTrials.gov Identifier: NCT04030572
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This will be a Phase 1, open label study of the pharmacokinetics (PK) and pharmacodynamics (PD) of clonidine, an alpha-2 adrenergic (a2a) agonist, in healthy volunteers. The primary aim is to show that the drug regimen is safe and reasonably well tolerated. The secondary aim is to demonstrate that safety can be monitored with home health devices.

Condition or disease Intervention/treatment Phase
Neuro-Degenerative Disease Cancer Drug: Clonidine Pill Early Phase 1

Detailed Description:

Subjects who screen in will participate in a drug-free lead-in period of one week duration. Then, the drug test article, clonidine HCl, 0.1 mg tabs, will be administered once daily by mouth at bedtime for one week. Steady-state PK will be measured on Day 8 post-drug with a single blood draw of 10 mL. This will be followed by a one week wash out period. During each of these three different one-week periods, sleep quality will be monitored nightly with a blue tooth and wireless enabled, wearable sleep tracker. Vital signs (VSs) will be monitored daily at home with a blue tooth and wireless enabled blood pressure machine. VSs and electrocardiograms (ECGs) will be measured before drug on Day (-7) and Day 1. Repeat measurements will be made during clinic visits on Day 2, Day 8, and Day 16.

The findings should show that there is, or is not, a PD effect produced by this rather low dose of drug administered for a relatively short period of time. Showing a PD effect at a safe and reasonably well tolerated dose would qualify this drug dosing regimen as a pharmacological challenge in future studies.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study to Assess the Safety, Tolerability, and Feasibility of Administering Clonidine as a Pharmacological Challenge in Future Imaging Studies of Cerebrospinal Fluid Kinetics
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clonidine Pill
One week period of clonidine, 0.1 mg tabs, one by mouth daily at bedtime
Drug: Clonidine Pill
0.1 mg tabs, one by mouth daily at bedtime for one week
Other Name: On-Drug




Primary Outcome Measures :
  1. Number of subjects experiencing adverse events related to drug-induced changes in hemodynamic function. [ Time Frame: Day 2 or Day 8 compared to Day (-7) through Day 1 during drug-free lead-in ]
    clinically significant drop in blood pressure or pulse


Secondary Outcome Measures :
  1. Change in Total Sleep Duration [ Time Frame: Day 2 and Day 8 on drug and Day 16 washout compared to Day (-7) through Day 1 during drug-free lead-in ]
    Time interval between falling asleep and waking up as estimated by a wearable sleep tracking device

  2. Change in Deep Sleep Time [ Time Frame: Day 2 and Day 8 on drug and Day 16 washout compared to Day (-7) through Day 1 during drug-free lead-in ]
    amount of time estimated to be in deep sleep versus light sleep by a wearable sleep tracking device



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • able to give informed consent.
  • age 18-89
  • Subjectively healthy and, in the opinion of the investigators, likely to be compliant with the drug regimen and the schedule of follow up visits.
  • Normal hemodynamic function. Systolic blood pressure and pulse must be higher than 120 mmHg and 60 beats per minute while sitting. At the discretion of the investigators, athletic people who are in exceptionally robust condition may be enrolled if their systolic blood pressure and pulse are higher than 100 mmHg and 50 beats per minute while sitting.
  • Unremarkable electrocardiograms with PR intervals of less than 200 mSec and QT intervals corrected with Fridericia's method (QTcF) of less than 440 mSec.
  • No concurrent medications with the exception of p.r.n. NSAIDS, which must be discontinued one week prior to the lead-in period, and avoided for the next three weeks while on study (the one week lead-in period, one week on drug period, and one week washout period).
  • Willing and able to refrain from abusing any recreational drugs, including marijuana because of its sleep effects, and drink less than one unit of alcoholic beverages per day starting one week prior to the lead-in period, and avoided for the next three weeks while on study (the one week lead-in period, one week on drug period, and one week washout period).
  • Willing to refrain from donating blood while during the month of study.
  • Willing to refrain from participating in any other research study that requires taking medication during the month of study.
  • Willing to refrain from being vaccinated during the month of study.

Exclusion Criteria:

  • History of allergy to clonidine.
  • History of multiple hypersensitivity reactions, as indicated by allergies to multiple medications, foods, and seasonal pollen.
  • History or physical examination suggestive of a condition, disorder, or disease that could represent a contra-indication to taking an antihypertensive. The relative contraindications to clonidine listed in the package insert under the section on precautions will be exclusionary in this study. They include subjects with coronary artery insufficiency syndromes, histories of myocardial infarction, cardiac conduction abnormalities, cerebrovascular disease, and chronic renal failure.
  • Women who are pregnant or breast feeding will not be eligible to participate in the study, as clonidine is classified as a Class C risk to a fetus. (In fact, there is a safety signal in pregnant animal models that justifies exclusion, even if the signal is weak.)
  • History or physical examination suggestive of a condition, disorder, or disease that could affect the adsorption, distribution, metabolism or excretion of the study drug.
  • Positive urine toxicology screen for recreational drugs, other than cannabis.
  • History of attention deficit hyperactivity disorder (ADHD) as a child or a residual disorder as an adult, because safety, tolerability, and patient acceptability have already been shown in these populations.
  • Subjects may not be a member of a vulnerable population.
  • May not have taken any controlled medications, including other study drugs, in the last 30 days or for 10 half-lives, whichever is longer.
  • May not have donated blood in the 30 days prior to the start of the lead-in period.
  • May not have participated in research administering drugs in the last 30 days.
  • May not have been vaccinated in the 30 days prior to the start of the lead-in period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030572


Contacts
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Contact: P. David Mozley, MD 212 746 5805 dvm9029@med.cornell.edu
Contact: Weill Medical College of Cornell University 646 962 8200 jcto@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Not yet recruiting
New York, New York, United States, 10065
Contact: P. David Mozley, MD    212-746-5805    dvm9029@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: P. David Mozley, MD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04030572     History of Changes
Other Study ID Numbers: 19-04020242
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All de-identified on-study data will be shared.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will be made available within six months of last study visit or acceptance for publication, whichever comes first.
Access Criteria: Any reasonable request sent to dvm9029@med.cornell.edu

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Clonidine
Neurodegenerative Diseases
Nervous System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action