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COMPLETED Phase 2

Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

NCT02635035 · View on ClinicalTrials.gov ↗

Study Summary

The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT). Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout period.

Interventions

  • DRUG Placebo
  • DRUG Lisdexamfetamine

Study Locations (2)

New York

  • Mount Sinai School of Medicine — New York
  • New York University School of Medicine — New York

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2015-11
Est. Completion 2019-01-09
Phase Phase 2

Sponsor

NYU Langone Health

1,204 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02635035

The ClinicalTrials.gov registry entry for NCT02635035 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02635035 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02635035 about?

NCT02635035 is a clinical study titled "Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT". The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with atte...

What is the current status of trial NCT02635035?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2015-11. Estimated completion is 2019-01-09.

What conditions does trial NCT02635035 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02635035?

The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02635035?

This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02635035 being conducted?

This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial