An interventional study of Sham Light and Bright Light Therapy in Prader-Willi Syndrome, Excessive Daytime Sleepiness and Hyperphagia, sponsored by Maimonides Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 6 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Maimonides Medical Center · Not applicable, Interventional, and Treatment
Among 69 studies in Prader-Willi Syndrome with a site in United States — 9 open to participants now, 14 under way, 3 of them phase 3. Prader-Willi Syndrome · United States.
Among the 69 studies in Prader-Willi Syndrome with a site in United States, this one is the 18th largest by planned enrollment of the 58 interventional ones that give a count, is one of 7 that started in 2023, is one of 15 with no phase, reaches primary completion later than 2 of the 13 other live ones, and was the 50th registered.
144 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.
Browse Prader-Willi Syndrome studies →9 of the 69 studies in Prader-Willi Syndrome with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
ConSynance Therapeutics · Sites in United States
Grace Kim · Sites in United States
University of North Carolina, Chapel Hill · Sites in United States
Harmony Biosciences Management, Inc. · Sites in United States, Australia, Belgium and 10 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Prader-Willi Syndrome studies recruiting now, 7 (44%) set no upper age limit and 9 (56%) stop at 75 or younger; 11 take children under 18; 1 take healthy volunteers.
This study: 6 Years to 88 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
69 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 23 · Phase 3 16 · Phase 4 3
First in 1999; this study’s year is marked. 7 started in 2023.
This study's planned enrollment of 50 is above the median of 30 across 100 interventional studies indexed under Prader-Willi Syndrome.
Median enrollment 23 across the 58 interventional studies, 200 across the 11 observational. Of the 51 that completed or were terminated, 21 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
32 of 69 have an industry lead sponsor. The 10 most frequent:
Maimonides Medical Center is the lead sponsor of 50 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Maimonides Medical Center has 2 studies filed under Prader-Willi Syndrome — fewer than ten, so there is no comparison to draw.
7 of the studies in Prader-Willi Syndrome with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06366464Phase 3Harmony Biosciences Management, Inc.A Study of Pitolisant in Patients With Prader-Willi Syndrome | 2027-04 |
| NCT06144645Phase 3Foundation for Prader-Willi ResearchA Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS | 2027-04-01 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
| NCT06239116Rhythm Pharmaceuticals, Inc.A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment | 2027-05-07 |
| NCT07348601ConSynance TherapeuticsA Study of CSTI-500 in Patients With Prader-Willi Syndrome | 2027-06 |
Among the 69 studies in Prader-Willi Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis.
Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Sham Light
Other: Bright Light Therapy
Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
Bright Light Therapy will be provided using light box with an artificial full spectrum lamp at a distance of at least 70cm but no greater than 90cm.
Clinical Global Impression- Improvement (CGI-I)
A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.
Time frame: 8 Weeks
Aberrant Behavior Checklist
Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).
Time frame: 8 Weeks
Self-Injury Trauma scale
Scores of 5 or greater were found to be indicative of borderline personality disorder. Part 1 is ranking based on the number of wounds 1=one would (common in a mild self-injurious behavior but rare in a severe case) 2=two or four wounds (common) and 3=five or more wounds (rare). Injury severity is scored on a subjective basis with labels such as "mild" "moderate" and "severe" accompanied by descriptions of the observed state of the anatomy. Part 3 is the Estimate of Current Risk.
Time frame: 8 Weeks
Modified Overt Aggression Scale
Four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes.\[1\] The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others
Time frame: 8 Weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2023 to primary completion in Sep 2026, 35 months.
Of 19 interventional studies with no phase under Prader-Willi Syndrome, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's 35 months is above that.
Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2026 → Sep 2026, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Maimonides Medical Center