Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01337700 · ClinicalTrials.gov registry record · Phase 4
Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT01337700 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT01337700, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism. This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.
Interventions
- DRUG Placebo
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01337700
The ClinicalTrials.gov registry entry for NCT01337700 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01337700 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01337700 about?
NCT01337700 is a clinical study titled "Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism". Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects ...
What is the current status of trial NCT01337700?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2011-02. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01337700?
The interventions under investigation include: Placebo (DRUG), Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01337700?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.