Trial · Interventional

CompletedPhase 1Registry data

Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

Short name FTDOXY10EF

NCTNCT01386333Other idR-11-232Other id17783

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 23 participants (actual)
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Canada
Start: Jun 2011
Primary completion: Oct 2013
Completion: Not stated
First posted: 1 Jul 2011 (estimated)
Last update posted: 4 Nov 2013 (estimated)
Conditions: Frontotemporal Dementia

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

Ph 1
FTDOXY10EF
NCT01386333
Jun 2011 to Oct 2013 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.

Interventions

oxytocinDrug
Saline Nasal MistDrug

Arms4

Experimental
Oxytocin 24IU
Oxytocin 24 IU administered intranasally twice daily for 1 week
Experimental
Oxytocin 48 IU
48 IU of intranasal oxytocin administered twice daily for 1 week
Experimental
72 IU oxytocin
72 IU of intranasal oxytocin administered twice daily for 1 week
Placebo comparator
Saline nasal spray

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame · 2 week
Registry description
Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.

Secondary outcomes(6)

Neuropsychiatric Inventory
Time frame · 1 week
Registry description
Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
Frontal Behavioural Inventory
Time frame · 1 week
Clinicians Global Impression of Change
Time frame · 1 week
Clinical Dementia Rating- Frontotemporal Lobar Degeneration
Time frame · 1 week
Interpersonal Reactivity Index
Time frame · 1 week
Multi-faceted Empathy Test
Time frame · 1 week

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

3 results

Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability.

Finger et al. 2015Neurologycited by 75

PMID 25503617PMC4336088DOI 10.1212/wnl.0000000000001133PUB-25503617

Rights unknown3 results

Source link See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age 30-80 years * Meets "Neary criteria" for diagnosis of probable frontotemporal dementia * Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia * Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent. Exclusion Criteria: * Has a history of a myocardial infarction within the last two years or congestive heart failure. * Current uncontrolled hypertension * Current bradycardia (rate \< 50 beats per minute/bpm) or tachycardia (rate \> 100 bpm) * Current hyponatremia * Current use of prostaglandin medications * Females who are pregnant or breastfeeding * Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.

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