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tasimelteon for Smith-Magenis Syndrome

Phase 2 & 3

Waitlist Available

Research Sponsored by Vanda Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 137 weeks

Awards & highlights

Study Summary

This trial looks at whether tasimelteon improves sleep for people with Smith-Magenis Syndrome.

Eligible Conditions

Smith-Magenis Syndrome
Circadian Rhythm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 137 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 137 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 137 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters

Secondary outcome measures

Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).

Side effects data

From 2012 Phase 3 trial • 20 Patients • NCT01430754

Nasopharyngitis

Blood creatine phosphokinase

Alanine aminotransferase

Crystal urine present

Protein urine present

Headache

Constipation

Diarrhoea

Urine abnormality

Arthralgia

Serotonin Syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Total Run-In

Run-In - Not Randomized

Tasimelteon

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TasimelteonExperimental Treatment1 Intervention

Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage

Group II: PlaceboPlacebo Group2 Interventions

Placebo comparator

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tasimelteon

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor

61 Previous Clinical Trials

19,355 Total Patients Enrolled

3 Trials studying Smith-Magenis Syndrome

1,032 Patients Enrolled for Smith-Magenis Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do theParameters of this study allow for subjects who are elderly?

"Enrolment for this study is restricted to patients aged 16-65. There are 6 similar trials available for minors and 4 for adults over the age of 65."

Answered by AI

Does this study represent novel research?

"Tasimelteon has been under clinical investigation since 2015. The first trial, which was sponsored by Vanda Pharmaceuticals and had 48 participants, occurred that year. After the initial study's success, tasimelteon received Phase 2 & 3 drug approval in ____. At present, there are 3 open trials involving tasimelteon being conducted across 21 cities in 1 nation."

Answered by AI

Who meets the eligibility criteria for participating in this research project?

"The ideal candidates for this clinical trial are 16 to 65 years old, have 17p11.2 monosomy, and meet the other requirements listed on the website. Currently, they are recruiting 48 patients in total."

Answered by AI

Is there availability in this study for new participants?

"This research is not currently looking for new participants. The study was created on September 1st, 2015 and updated on May 12th, 2016. There are 4 other clinical trials related to 17p11.2 monosomy that are actively recruiting patients and 3 studies concerning tasimelteon also have open enrollment."

Answered by AI

Can you provide more information on tasimelteon's research history?

"Tasimelteon was first studied five years ago at Santa Monica Clinical Trials. Since then, a total of 16 clinical trials have been completed with 3 more presently underway. These ongoing studies are located in the city of Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

2015. "Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02231008.