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TerminatedNCT04030572a2a AgonistUpdated Jun 24, 2021

Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies

An Early Phase 1 interventional study of Clonidine Pill in Neuro-Degenerative Disease and Cancer, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Weill Medical College of Cornell University · Early Phase 1, Interventional, and Basic science

Why this study was terminated
Not logistically feasible during the COVID pandemic

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 6 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neuro-Degenerative Disease
  • Cancer
03

In context

Neurodegenerative Diseases

370 studies on the registry are indexed under Neurodegenerative Diseases; 145 are open to participants now.

This study's enrollment of 3 is below the median of 53 across 204 interventional studies indexed under Neurodegenerative Diseases.

Browse Neurodegenerative Diseases studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Clonidine Pill

    One week period of clonidine, 0.1 mg tabs, one by mouth daily at bedtime

    Drug: Clonidine Pill

Interventions

  • DrugClonidine Pill

    0.1 mg tabs, one by mouth daily at bedtime for one week

    Also known as: On-Drug

06

What researchers measure

Primary outcomes

  1. Number of subjects experiencing adverse events related to drug-induced changes in hemodynamic function.

    clinically significant drop in blood pressure or pulse

    Time frame: Day 2 or Day 8 compared to Day (-7) through Day 1 during drug-free lead-in

Secondary outcomes

  1. Change in Total Sleep Duration

    Time interval between falling asleep and waking up as estimated by a wearable sleep tracking device

    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

  2. Change in Deep Sleep Time

    amount of time estimated to be in deep sleep versus light sleep by a wearable sleep tracking device

    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

07

Study locations

1 site
  • Weill Cornell Medicine
    New York, New York 10065, United States
08

References and documents

Individual participant data

Plan to share: Yes — All de-identified on-study data will be shared.

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04030572
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jul 24, 2019
Start date
Dec 10, 2019
Primary completion
Mar 17, 2020
Completion
Mar 17, 2020
Last update
Jun 24, 2021

Study contacts

P. David Mozley, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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