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Intranasal Oxytocin for Frontotemporal Dementia (FOXY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03260920
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : February 26, 2020
Weston Brain Institute
Canadian Institutes of Health Research (CIHR)
Berry Consultants
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE July 19, 2017
First Posted Date  ICMJE August 24, 2017
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE January 31, 2018
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score [ Time Frame: Up to 20 weeks ]
Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Change in emotional facial expression recognition performance [ Time Frame: Up to 20 weeks ]
  • Change in the Revised Self-Monitoring Scale score [ Time Frame: Up to 20 weeks ]
  • Change in modified Clinicians Global Impression of Change (apathy) scores [ Time Frame: Up to 20 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Intranasal Oxytocin for Frontotemporal Dementia
Official Title  ICMJE A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia
Brief Summary The purpose of this study is to assess the safety, tolerability and effects on behaviour of Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive saline substance that contains no medication) in participants with frontotemporal dementia/Pick's disease. This study will take place in approximately 15 centres across Canada and the United States. Approximately 112 patients in total will be enrolled in this study. In the first phase we will examine which of three different dosing schedules of oxytocin may be more effective. In the second phase of the study, patients entering the study will be randomized to the oxytocin dosing schedule that appeared most effective in the first phase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Frontotemporal Dementia
Intervention  ICMJE Drug: Syntocinon
Intranasal Oxytocin
Other Name: Intranasal Oxytocin
Study Arms  ICMJE
  • Experimental: Low Dose
    Intervention: Drug: Syntocinon
  • Experimental: Medium Dose
    Intervention: Drug: Syntocinon
  • Experimental: High Dose
    Intervention: Drug: Syntocinon
Publications * Finger E, Berry S, Cummings J, Coleman K, Hsiung R, Feldman HH, Boxer A. Adaptive crossover designs for assessment of symptomatic treatments targeting behaviour in neurodegenerative disease: a phase 2 clinical trial of intranasal oxytocin for frontotemporal dementia (FOXY). Alzheimers Res Ther. 2018 Sep 27;10(1):102. doi: 10.1186/s13195-018-0427-2.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable FTD (behavioural variant FTD, FTD-semantic subtype or FTD-Progressive Nonfluent Aphasia) with supportive brain imaging (centrally rated frontotemporal atrophy score of 2 or greater on brain MRI or CT) or known FTD causing genetic mutation.68
  • Current symptoms of social apathy/indifference as measured by NPI apathy/indifference severity subscale score >= 2 indicating the presence of moderate to marked levels of apathy/indifference.
  • Study partner who consents to study participation and who cares for/visits the patient daily for at least 3 hours/day and who can administer all trial medications.
  • FTLD-CDR score 0-2.
  • MMSE >10.
  • Stable baseline medications related to cognition or behaviour for >=30 days such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines.
  • Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from their substitute decision maker).

Exclusion Criteria:

  • History of stroke, other neurologic or psychiatric disorder other than FTD that is considered to better account for behavioural symptoms.
  • 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 (Na <135 mEq/L)
  • Current use of topical prostaglandin medications applied to the cervix.
  • Females who are pregnant or breastfeeding, or planning to conceive within the study period.
  • 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.
  • Participant has speech difficulties that in the opinion of the investigator would be incompatible with neuropsychology and safety assessments
  • History of cancer except:

    • If considered to be cured
    • If not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the investigator, not likely to require treatment in the ensuing 5 years
    • For prostate cancer or basal cell carcinoma, no significant progression over the previous 2 years
  • Any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
  • For the CSF sub-study, current use of anticoagulant medications (warfarin, rivaroxaban, etc.).
  • Plan for FTD patient to be placed into long-term care or plan for hospital admission for any kind of treatment within study period or if caregiver plans for holidays/respite care > 3 days during study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03260920
Other Study ID Numbers  ICMJE FTDOXY17EF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE
  • Weston Brain Institute
  • Canadian Institutes of Health Research (CIHR)
  • Berry Consultants
Investigators  ICMJE Not Provided
PRS Account Lawson Health Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP