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Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome (PRADOTIM)

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ClinicalTrials.gov Identifier: NCT02804373
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: Oxytocin (OXT) continuous Drug: Placebo Drug: Placebo continuous Drug: Oxytocin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
Study Start Date : June 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: placebo daily
daily administration of placebo during 28 days : placebo continuous
Drug: Placebo continuous
Placebo administration the following 2 days after each OXT administration, during 28 days.

Active Comparator: 24 IU of oxytocin daily
24 IU of daily oxytocin administration during 28 days : oxytocin continuous
Drug: Oxytocin (OXT) continuous
Administration of 24 IU of oxytocin daily during 28 days
Other Name: Syntocinon

Active Comparator: 24 IU of oxytocin every 3 days
24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
Drug: Placebo
Placebo daily during 28 days

Drug: Oxytocin
Administration of 24 IU of oxytocin every 3 days during 28 days.
Other Name: Syntocinon




Primary Outcome Measures :
  1. Change in Behaviour as assessed by score variations in specific questionaries [ Time Frame: Every day before and after administration of treatment during 28 days ]
  2. Change in eating Behaviour as assessed by score variations in specific questionaries [ Time Frame: Every day before and after administration of treatment during 28 days ]

Secondary Outcome Measures :
  1. Change in eating behaviour as assessed by score variations in hunger visual analogic scale [ Time Frame: Every day before and after administration of treatment during 28 days ]
  2. Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan) [ Time Frame: Day 1, day 2 and day 30 ]
    Brain imaging

  3. Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI) [ Time Frame: Day 1, day 2 and day 29 ]
    Brain imaging

  4. Evaluation of social skills assessed by specific questionnaires [ Time Frame: Day 1, day 2 and day 30 ]
  5. Evaluation of executive function assessed by specific questionnaires [ Time Frame: Day 1, day 2 and day 30 ]
  6. Evaluation of theory of mind assessed by specific questionnaires [ Time Frame: Day 1, day 2 and day 30 ]
  7. Social processing assessed by oculomotor exploration [ Time Frame: Day 1, day 2 and day 30 ]
  8. Multisensory processing assessed by Neurovisual task [ Time Frame: Day 1, day 2 and day 30 ]
  9. Hormon blood concentration levels as assessed by bioassays [ Time Frame: Day 2 and day 30 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prader-Willi syndrome genetically confirmed
  • Absence of extension of the QT interval in the electrocardiogram
  • Absence of hypokalemia

Exclusion Criteria:

  • Psychiatric troubles
  • Anomalies of the heart rhythm in significant ECG
  • Hepatic insufficiency
  • Renal insufficiency
  • Patients presenting a pregnancy or breast-feeding
  • High sensibility to OT
  • High sensibility to the excipients of the product
  • Patients having family history of genetic pathology causing an extension of the interval QT
  • Patients having risk factors of advanced twist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804373


Contacts
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Contact: Maïthé TAUBER tauber.m@chu-toulouse.fr

Locations
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France
Centre de référence Prader-Willi - Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Maïthé Tauber       tauber.m@chu-toulouse.fr   
Contact: Marion Valette       valette.m@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Maithé TAUBER, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02804373     History of Changes
Other Study ID Numbers: 13 6872 03
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
oxytocin
adults
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs