Spinal Cord InjuriesPhase 2NCT04799782

Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

A Phase 2 study testing Mirtazapine in people with Spinal Cord Injuries and Sleep Disordered Breathing, run by Wayne State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Spinal Cord Injuries, Sleep Disordered Breathing
What is being tested?: Mirtazapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: No sites listed yet
Study dates: Jan 2017to 18 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults with SCI (>6months after spinal cord injury) at the T6 level/above
Non-injured adults

Who cannot join

Pregnant and lactating females
Heart failure, vascular disease, or stroke
Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
BMI >38 kg/m2
Mechanical ventilation dependence

About this study

The purpose of this study is to look at the effect of using Mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the Mirtazapine/placebo pill has on the way the body responds during sleep.

Read the detailed description

Randomized placebo controlled cross-over study. Each subject will be studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; the participants will be blinded to whether they are taking Mirtazapine or placebo. After the one week treatment a sleep study will be repeated. Mirtazapine will be given at 15 mg dose before bed-time. (2) Cross over medication for one week will be followed by a second sleep study.

Conditions: Spinal Cord Injuries, Sleep Disordered Breathing
Being tested: Mirtazapine, Placebo
Medical subject headings: Spinal Cord Injuries, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MirtazapineDrug
15 mg dose before bed-time
PlaceboDrug
One placebo pill before bed-time

Study groups in NCT04799782
Study group	Role	What they receive
Mirtazapine	Active comparator	The drug will be taken for a one week peroid. Receives: Drug: Mirtazapine
Placebo	Placebo comparator	The drug will be taken for a one week peroid. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

CO2 Reserve (Delta-PETCO2-AT)
Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.
Measured: One Week

Secondary outcomes (1)

AHI (Apnea/Hypopnea Index)
AHI is an index that measures the severity of sleep apnea and is calculated by dividing the total number of apneas and hypopneas by the number of hours of sleep. Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a polysomnogram (PSG) study was performed to determine the AHI. (2) Cross over medication for one week was followed by a second PSG to determine the AHI.
Measured: One Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201718 May 2019

First posted16 Mar 2021
Study startJan 2017
Primary completion18 May 2019
Study completion18 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04799782
Sponsor's protocol ID: 100712M1F(V)
Status last verified: May 2021
First submitted: 11 Mar 2021
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
ClinicalTrials.gov ID: NCT04799782
Acronym / sponsor ID: 100712M1F(V)
Conditions: Spinal Cord Injuries, Sleep Disordered Breathing
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Wayne State UniversityUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: 18 May 2019 (actual)
Study completion: 18 May 2019 (actual)
First posted: 16 Mar 2021 (actual)
Results: Posted 20 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Mirtazapine	Active comparator	Drug: MirtazapineThe drug will be taken for a one week peroid.
Placebo	Placebo comparator	Drug: PlaceboThe drug will be taken for a one week peroid.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults with SCI (>6months after spinal cord injury) at the T6 level/above
Non-injured adults

Key exclusion criteria (5 listed)

Pregnant and lactating females
Heart failure, vascular disease, or stroke
Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
BMI >38 kg/m2
Mechanical ventilation dependence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mirtazapine15 mg dose before bed-time	Drug	Mirtazapine
PlaceboOne placebo pill before bed-time	Drug	Placebo

Primary outcome

CO2 Reserve (Delta-PETCO2-AT)
Time frame: One Week
Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.

1 secondary outcome

AHI (Apnea/Hypopnea Index)
Time frame: One Week

Results and safety

Results posted to the registry on 20 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo->Mirtazapine	8	8
Mirtazapine->Placebo	7	7

Primary outcome: CO2 Reserve (Delta-PETCO2-AT)

Time frame: One Week. Mean (Standard Deviation). Unit: mmHg

Measure	Mirtazapine n = 10	Placebo n = 10
Value	-3.8 (1.2)	-2.0 (1.5)

Mirtazapine vs Placebo: p = 0.015, t-test, 2 sided

Population analysed: Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirtazapine	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Placebo	1 of 12 (8.3%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): * The sample size is small and the majority are males, therefore findings from this study may not be applicable to the general population * The study required heavy instrumentation which may have affected natural sleep

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirtazapine in people with Spinal Cord Injuries and Sleep Disordered Breathing, run by Wayne State University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CO2 Reserve (Delta-PETCO2-AT) (time frame: One Week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.