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NCT01537471: PPI
A Pilot Study of the Effects of Meclizine on Pre-Pulse Inhibition
Phase 1 trial testing Placebo in Healthy in 117 participants. Completed in 1 September 2012.
1 September 2012
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 1 January 2012 |
| Primary completion | 1 September 2012 |
| Estimated completion | 1 September 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Duke University
Who can join
Adults 18 to 40, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in PPI
Time frame: Screening Day 1, Days 2-4
The primary outcome will measure change in subjects' PPI depending on whether they were given meclizine during the study. Prepulse inhibition (PPI) of the startle reflex by a weak pre-pulse will be assessed during each laboratory session. It is measured using electromyographic (EMG; i.e., for assessing eye blink magnitude) responses.
Sponsor's own description
The purpose of the investigators research is to test whether problems people have with processing their senses (feeling overwhelmed, distracted or upset by sounds and other stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines, which are medicines used for things like allergies, sleep problems, or the common cold.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01537471
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Duke University trials
Trials by the same sponsor.
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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 NCT01537471 (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 Duke University
- Last refreshed: 15 January 2013
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/NCT01537471.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing