Prader-Willi SyndromePhase 2/3PRADOTIMNCT02804373
Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
A Phase 2/3 study testing Oxytocin (OXT) continuous and Oxytocin in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Oxytocin (OXT) continuous and Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to 18 Jun 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prader-Willi syndrome genetically confirmed
- Absence of extension of the QT interval in the electrocardiogram
- Absence of hypokalemia
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Oxytocin (OXT) continuous, Placebo, Placebo continuous, Oxytocin
- Keywords
- oxytocin, adults
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin (OXT) continuousDrug
Also called Syntocinon
Administration of 24 IU of oxytocin daily during 28 days
PlaceboDrug
Placebo daily during 28 days
Placebo continuousDrug
Placebo administration the following 2 days after each OXT administration, during 28 days.
OxytocinDrug
Also called Syntocinon
Administration of 24 IU of oxytocin every 3 days during 28 days.
| Study group | Role | What they receive |
|---|---|---|
| placebo daily | Placebo comparator | daily administration of placebo during 28 days : placebo continuous Receives: Drug: Placebo continuous |
| 24 IU of oxytocin daily | Active comparator | 24 IU of daily oxytocin administration during 28 days : oxytocin continuous Receives: Drug: Oxytocin (OXT) continuous |
| 24 IU of oxytocin every 3 days | Active comparator | 24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days Receives: Drug: Placebo; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behaviour as assessed by score variations in specific questionaries
Measured: Every day before and after administration of treatment during 28 days
Change in eating Behaviour as assessed by score variations in specific questionaries
Measured: Every day before and after administration of treatment during 28 days
Secondary outcomes (9)
Change in eating behaviour as assessed by score variations in hunger visual analogic scale
Measured: Every day before and after administration of treatment during 28 days
Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)
Brain imaging
Measured: Day 1, day 2 and day 30
Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)
Brain imaging
Measured: Day 1, day 2 and day 29
Evaluation of social skills assessed by specific questionnaires
Measured: Day 1, day 2 and day 30
Evaluation of executive function assessed by specific questionnaires
Measured: Day 1, day 2 and day 30
Evaluation of theory of mind assessed by specific questionnaires
Measured: Day 1, day 2 and day 30
Social processing assessed by oculomotor exploration
Measured: Day 1, day 2 and day 30
Multisensory processing assessed by Neurovisual task
Measured: Day 1, day 2 and day 30
Hormon blood concentration levels as assessed by bioassays
Measured: Day 2 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionJan 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maithé TAUBER, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804373
- Sponsor's protocol ID
- 13 6872 03
- Acronym
- PRADOTIM
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2015
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Salles J, Strelnikov K, Carine M, Denise T, Laurier V, Molinas C, Tauber M, Barone P. Deficits in voice and multisensory processing in patients with Prader-Willi syndrome. Neuropsychologia. 2016 May;85:137-47. doi: 10.1016/j.neuropsychologia.2016.03.015. Epub 2016 Mar 16.
PubMed 26994593
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT02804373
- Acronym / sponsor ID
- PRADOTIM / 13 6872 03
- Conditions
- Prader-Willi Syndrome
- Keywords
- oxytocin, adults
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo daily | Placebo comparator | Drug: Placebo continuousdaily administration of placebo during 28 days : placebo continuous |
| 24 IU of oxytocin daily | Active comparator | Drug: Oxytocin (OXT) continuous24 IU of daily oxytocin administration during 28 days : oxytocin continuous |
| 24 IU of oxytocin every 3 days | Active comparator | Drug: Placebo, Drug: Oxytocin24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Prader-Willi syndrome genetically confirmed
- Absence of extension of the QT interval in the electrocardiogram
- Absence of hypokalemia
Key exclusion criteria (9 listed)
- Psychiatric troubles
- Anomalies of the heart rhythm in significant ECG
- Hepatic insufficiency
- Renal insufficiency
- Patients presenting a pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin (OXT) continuousAlso: SyntocinonAdministration of 24 IU of oxytocin daily during 28 days | Drug | 24 IU of oxytocin daily |
| PlaceboPlacebo daily during 28 days | Drug | 24 IU of oxytocin every 3 days |
| Placebo continuousPlacebo administration the following 2 days after each OXT administration, during 28 days. | Drug | placebo daily |
| OxytocinAlso: SyntocinonAdministration of 24 IU of oxytocin every 3 days during 28 days. | Drug | 24 IU of oxytocin every 3 days |
Primary outcome
Change in Behaviour as assessed by score variations in specific questionaries
Time frame: Every day before and after administration of treatment during 28 days
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
9 secondary outcomes
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
Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)
Time frame: Day 1, day 2 and day 30
Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)
Time frame: Day 1, day 2 and day 29
Evaluation of social skills assessed by specific questionnaires
Time frame: Day 1, day 2 and day 30
Evaluation of executive function assessed by specific questionnaires
Time frame: Day 1, day 2 and day 30
Evaluation of theory of mind assessed by specific questionnaires
Time frame: Day 1, day 2 and day 30
Social processing assessed by oculomotor exploration
Time frame: Day 1, day 2 and day 30
Multisensory processing assessed by Neurovisual task
Time frame: Day 1, day 2 and day 30
Hormon blood concentration levels as assessed by bioassays
Time frame: Day 2 and day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 26994593Salles J, Strelnikov K, Carine M, Denise T, Laurier V, Molinas C, Tauber M, Barone P. Deficits in voice and multisensory processing in patients with Prader-Willi syndrome. Neuropsychologia. 2016 May;85:137-47. doi: 10.1016/j.neuropsychologia.2016.03.015. Epub 2016 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maithé TAUBER, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxytocin (OXT) continuous and Oxytocin in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behaviour as assessed by score variations in specific questionaries (time frame: Every day before and after administration of treatment during 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.