Phase 3 Sleep Disorders Trial, Recruiting (NCT04652882)

Phase 3 Sleep Disorders Trial, Recruiting NCT04652882 Sponsor: Vanda Pharmaceuticals Condition: Sleep Disorders

Printed from Voxsanity (voxsanity.com.au) — NCT04652882 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Sleep Disorders

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People who are willing and able to give written consent to participate.
People who have been clinically diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD), a condition where a person's sleep timing is significantly shifted later than normal.
People between the ages of 18 and 75 years old (inclusive).
People whose Body Mass Index (BMI) falls between 18 and 35 kg/m² (a standard measure of body weight relative to height).

Who may not be able to join:

People whose existing mental health condition has recently gotten worse and required a change in treatment or care within the past 3 months.
People who have had major surgery, a serious injury or illness, general anaesthesia, or have been unable to move around for 3 or more days within the last 30 days.
People who are currently pregnant, have given birth within the last 6 weeks, or are currently breastfeeding.
People who test positive for substances of abuse at screening.
People who currently use tobacco products.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 26 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 202-734-3400

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT04652882

Sponsor: Vanda Pharmaceuticals

Phase: Phase 3

Status: Recruiting

Condition: Sleep Disorders

Trial contact: 202-734-3400

More information: https://clinicaltrials.gov/study/NCT04652882

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

People who are willing and able to give written consent to participate.
People who have been clinically diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD), a condition where a person's sleep timing is significantly shifted later than normal.
People between the ages of 18 and 75 years old (inclusive).
People whose Body Mass Index (BMI) falls between 18 and 35 kg/m² (a standard measure of body weight relative to height).

Who may not be able to join:

People whose existing mental health condition has recently gotten worse and required a change in treatment or care within the past 3 months.
People who have had major surgery, a serious injury or illness, general anaesthesia, or have been unable to move around for 3 or more days within the last 30 days.
People who are currently pregnant, have given birth within the last 6 weeks, or are currently breastfeeding.
People who test positive for substances of abuse at screening.
People who currently use tobacco products.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 26 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Vanda Pharmaceuticals

Registry

ClinicalTrials.gov

Start date

9 December 2020

Est. completion

1 June 2026

Where this trial is recruiting

🇦🇹 Austria 🇩🇪 Germany 🇺🇸 United States

Primary endpoints

Change in Sleep Onset over the treatment period, as measured by sleep diary.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov