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NCT01207050
Pilot Study: The Effect of Rozerem on Sleep Disturbance After Traumatic Brain Injury
Phase 4 trial testing Ramelteon in Insomnia in 20 participants. Status unknown.
1 December 2014
Quick facts
| Lead sponsor | Kessler Foundation |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 September 2010 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ramelteon (RAMELTEON) — full drug profile →
- Placebo
Conditions studied
- Insomnia — all drugs for Insomnia →
- Brain Injury — all drugs for Brain Injury →
Sponsor
Kessler Foundation
Who can join
18 and older, any sex, with Insomnia or Brain Injury. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Sleep Quality
Time frame: At third week of treatment
Sleep Latency (the number of minutes it takes for the participant to fall asleep after getting into bed), and Total Sleep Time (number of minutes asleep between getting into bed for the night and getting out of bed in the morning).
Sponsor's own description
This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01207050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ramelteon
Trials testing the same drug.
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- 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- NCT03265951 — Ramelteon for Complex Insomnia in Veterans With PTSD · Phase 4 · withdrawn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 Insomnia
Currently open trials in the same condition.
- NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
- NCT07071324 — CF Wellness Program · NA · recruiting
- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Kessler Foundation trials
Trials by the same sponsor.
- NCT07168941 — Evaluation and Refinement of KF-STRIDE Into the Interview! · NA · not yet recruiting
- NCT07159100 — tDCS for Cancer-Related Fatigue and Weakness · EARLY_PHASE1 · not yet recruiting
- NCT06886152 — Spinal Stimulation and Gait Training to Improve Mobility in TBI · NA · not yet recruiting
- NCT07073313 — Using Muscle Functional MRI to Study Spatial Muscle Activation Patterns in People With SCI · not yet recruiting
- NCT06923293 — Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01207050 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kessler Foundation
- Last refreshed: 8 September 2014
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/NCT01207050.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing