NCT00325728 is a Phase 2 clinical trial of Ramelteon in Chronic Insomnia, sponsored by Takeda.

Who is sponsoring NCT00325728?

NCT00325728 is sponsored by Takeda.

What drugs are being tested in NCT00325728?

Interventions in NCT00325728: Ramelteon, Placebo.

What condition does NCT00325728 study?

NCT00325728 studies Chronic Insomnia.

Is NCT00325728 still recruiting?

NCT00325728 is currently completed. Last updated 14 August 2017.

Last reviewed 2017-08-14 · How we verify

NCT00325728

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

Completed Phase 2 Last updated 14 August 2017

What this trial tests

Phase 2 trial testing Ramelteon in Chronic Insomnia in 74 participants. Completed in 20 August 2007.

Timeline

21 March 2006

Primary endpoint
1 August 2007

20 August 2007

Quick facts

Lead sponsor	Takeda
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	74
Start date	21 March 2006
Primary completion	1 August 2007
Estimated completion	20 August 2007
Sites	72 locations across United States

Drugs / interventions tested

Ramelteon (RAMELTEON) — full drug profile →
Placebo

Conditions studied

Chronic Insomnia — all drugs for Chronic Insomnia →

Sponsor

Takeda — full company profile →

Who can join

55 and older, any sex, with Chronic Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacotherapies for sleep disturbances in dementia.
McCleery J, Cohen DA, Sharpley AL. · · 2016 · cited 63× · PMID 27851868 · DOI 10.1002/14651858.cd009178.pub3
Pharmacotherapies for sleep disturbances in dementia.
McCleery J, Sharpley AL. · · 2020 · cited 62× · PMID 33189083 · DOI 10.1002/14651858.cd009178.pub4
Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
Drug Discovery and Development Targeting Dementia.
Zagórska A, Czopek A, Fryc M, Jaromin A, et al · · 2023 · cited 18× · PMID 37259302 · DOI 10.3390/ph16020151

Verify or expand the search:

Other trials of Ramelteon

Trials testing the same drug.

NCT07382843 — Melatonin Agonist for Shift-time Workers. · Phase 4 · completed
NCT03165695 — Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults · Phase 4 · withdrawn
NCT03931070 — The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU · Phase 4 · completed
NCT03265951 — Ramelteon for Complex Insomnia in Veterans With PTSD · Phase 4 · withdrawn
NCT02669082 — The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Usi · Phase 4 · completed

Other recruiting trials for Chronic Insomnia

Currently open trials in the same condition.

NCT06251258 — Facial Emotion Recognition in Insomnia and Emotional Regulation · NA · recruiting
NCT06898099 — Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR) · NA · recruiting
NCT06983275 — Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms · NA · recruiting
NCT07429578 — Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study · NA · recruiting
NCT06658158 — Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients · NA · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00325728 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 14 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00325728.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing