Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in

See also
Status	Clinical Trial	Phase
Completed	`NCT00004351` - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes	N/A
Completed	`NCT02776215` - Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents	Phase 1
Recruiting	`NCT05116904` - Smith Magenis Syndrome and Autism Spectrum Disorders	N/A
Recruiting	`NCT04768803` - Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity

See also

Status

Clinical Trial

Phase

Completed

NCT00004351 - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes

N/A

Completed

NCT02776215 - Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Phase 1

Recruiting

NCT05116904 - Smith Magenis Syndrome and Autism Spectrum Disorders

N/A

Recruiting

NCT04768803 - Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02231008
Study type	Interventional
Source	Vanda Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 2015
Completion date	January 2022

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms