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A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05059600
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The primary purpose of this study is to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: ZULRESSO® Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting
Actual Study Start Date : November 5, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Brexanolone

Arm Intervention/treatment
Experimental: ZULRESSO®
Participants will administer ZULRESSO® in a home setting as a single, continuous, intravenous (IV) infusion for 60-hours (hrs) starting on Day 1.
Drug: ZULRESSO®
Intravenous infusion of ZULRESSO®.
Other Names:
  • Allopregnanolone
  • Brexanolone
  • SAGE-547




Primary Outcome Measures :
  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Dose Interruption/Discontinuation [ Time Frame: Up to 3 days ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with onset after the start of investigational product, or any worsening of a preexisting medical condition/adverse event with onset after the start of investigational product and throughout the study.


Secondary Outcome Measures :
  1. Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® [ Time Frame: Up to 3 days ]

    Nonadherence is defined by failure of any of the following:

    • Home infusion provider to train all pharmacy and healthcare providers (HPs) involved in dispensing/administration of ZULRESSO® on risk of excessive sedation/loss of consciousness
    • Home HPs to counsel participants on risk of excessive sedation and loss of consciousness
    • Deliver ZULRESSO® per protocol
    • Provide preprogrammed peristaltic pump
    • Home HP: assess for excessive sedation every 2 hrs in planned nonsleep periods, change infusion bag per protocol, available in participants home during infusion
    • Fall protocol in place
    • Monitor participants with pulse oximeter
    • Stop infusion when i) participant is primary caregiver of dependents, ii) identification of excessive sedation/loss of consciousness/hypoxic episode
    • Caution participants postinfusion against engaging in potentially hazardous activities requiring mental alertness
    • Complete AE special interest/Serious AE form
    • Infusion resumed after episode of hypoxia

  2. Percentage of Participants With Use-Related Issues Related to the Home Administration of ZULRESSO® [ Time Frame: Up to 3 days ]
    Throughout the duration of the infusion, home healthcare provider staff will complete checklists and/or journals at the end of each day and/or shift to document any use-related issues, including how the issues were addressed and followed-up. Any use-related issues determined to be critical in nature will be followed up immediately by a remote human factors team member so that the information is recent and can be reported adequately and analyzed for root causes.

  3. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 3 days ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE is defined as an adverse event with onset after the start of investigational product, or any worsening of a preexisting medical condition/adverse event with onset after the start of investigational product and throughout the study.

  4. Percentage of Participants With Medication Error [ Time Frame: Up to 3 days ]
    Medication error is any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication is in the control of the healthcare professional, participant, or consumer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ambulatory female ≥18 years of age.
  2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
  3. Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
  4. Participant has no history of sleep apnea or any clinically significant respiratory conditions.
  5. Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
  6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.
  7. Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:

    • safe environment for the home infusion provider staff.
    • access to a working telephone.
    • electricity and grounded electrical outlets.
    • running water.
    • access to back-up emergency services (911 service or ambulance availability).
    • sanitary environment.
  8. Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
  9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.

Exclusion Criteria:

  1. Participant has end stage renal failure.
  2. Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
  3. Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.

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): NCT05059600


Contacts
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Contact: Brent Allan, MD, DO, MPH, FAAFP 480-469-4640 brent.allan@sagerx.com

Locations
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United States, California
Virtual Site (recruiting nationwide) Recruiting
Culver City, California, United States, 90230
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT05059600    
Other Study ID Numbers: 547-PPD-404
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Pregnanolone
Brexanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Neurosteroids
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents