A Phase 2 interventional study of Oxytocin and Saline in Phelan-McDermid Syndrome, sponsored by Alexander Kolevzon. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by Alexander Kolevzon · Phase 2, Interventional, and Treatment
This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized, placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12 weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments in attention, social memory, socialization, language, and repetitive behaviors.
Alexander Kolevzon is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first phase of the study will follow a double-blind, placebo-controlled design. Participants randomized to the experimental group will receive intranasal oxytocin in doses of 24 IU, two times daily, for a total of 48 IU. Doses may be reduced by 8 IU/day if safety concerns emerge. During the second phase of the study, all participants will receive oxytocin, in identical doses.
Drug: Oxytocin
During the first phase, patients randomized to the placebo group will receive intranasal saline solution in doses of 24 IU two times daily, for a total of 48 IU. During the second phase of the study, all participants will receive oxytocin, in identical doses.
Drug: Saline
Intranasal oxytocin
Also known as: Syntocinon
Placebo
Change in Aberrant Behavior Checklist
Change in scale at week 12 as compared to baseline. Aberrant Behavior Checklist - behavior rating subscales for the assessment of treatment effects.16 items, Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). Total score range from 0 to 48, with higher score indicating poorer health outcomes.
Time frame: Baseline and Week 12
Change in Visual Paired Comparison (VPC) Task
Change in VPC Task has 2 subscores at week 12 as compared to baseline. The subject is initially presented with a target for familiarization and the familiar target is then paired with a novel target. Recognition is indexed by a novelty score derived from the percentage of time looking at the novel stimulus vs. the familiar stimulus. The Social-Novel Preference score refers to the proportion of time spent looking at novel stimuli out of all the time spent looking at both novel and familiar stimuli in the social test. The Nonsocial-Novel Preference score refers to the proportion of time spent looking at novel stimuli out of all the time spent looking at both novel and familiar stimuli in the nonsocial test.The scores are given in proportions with a range from -1 to 1. A score of -1 would mean the participant shows a preference for familiar stimuli and a score of 1 demonstrates a preference for novel stimuli.
Time frame: Baseline and Week 12
Change in Gap-Overlap Task
One of three computerized eye tracking tasks to measure attention. three computer screens are set up side by side. A stimulus initially appears on the central screen, and once the participant orients to that stimulus, another stimulus will appear on one of the lateral screens. In the "gap" condition, the central stimulus will disappear before the peripheral stimulus appears. In the "overlap" condition, the central stimulus will remain on the screen while the peripheral stimulus appears. In both conditions, reaction times of the participant's eye movements (saccadic reaction time) from the central stimulus to the peripheral stimulus will be measured. Gap Effect measures the difference between average Gap and Overlap saccade latencies.
Time frame: Baseline and Week 12
Change in Flicker Tasks
One of three computerized eye tracking tasks to measure attention. The "flicker task," or the four-alternative forced-choice preferential looking paradigm - the time interval over which the visual system is able to parse information. Scores range from -1 to 1 with higher scores indicating better (more typical) performance.
Time frame: Baseline and Week 12
Change in Vineland Adaptive Behavior Scales
Mean change in scale at week 12 as compared to baseline. Vineland Adaptive Behavior Communication Domain measures adaptive functioning. Vineland-II subdomains (Communication, Daily Living Skills, Socialization, Motor, Adaptive Behavior Composite, Internalizing, Externalizing and maladaptive) are V-scale scores (M=15, SD=3). Higher scores indicate better developed adaptive social behavior. Vineland-II domain and composite values are standard scores (M=100, SD=15). Higher scores indicate better developed adaptive social behavior.
Time frame: Baseline and Week 12
Change in Repetitive Behavior Scale-Revised (RBS-R)
Change in Repetitive Behavior Scale at week 12 as compared to baseline. the RBS-R is a 44-item self-report questionnaire consisting of subscales and one additional global rating score from 1-100. Score range for Stereotypic Behavior subscale is 0-27, Self-Injurious Behavior subscale is 0-24, Compulsive Behavior subscale is 0-18, Ritualistic/Sameness Behavior subscale is 0-36, and Restricted Interests subscale 0-9. Total scale for RBS-R is 0-214, with higher score indicating more severe problem.
Time frame: Baseline and Week 12
Change in Clinical Global Impression - Severity Scales
Mean Change in Clinical Global Impression-Severity Scales at week 12 as compared to baseline. Clinical Global Impressions (CGI) Rating Scales are commonly used to measure symptom severity and global improvement in treatment studies of patients with developmental disorders. There Severity Scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment. Full scale from 1 - 7. Higher scores indicate greater symptom severity.
Time frame: Baseline and Week 12
Change in Short Sensory Profile (SSP)
Mean Change in Short Sensory Profile Scale at week 12 as compared to baseline, measuring sensory sensitivity and sensory seeking behavior. The SSP is a 38-item caregiver questionnaire. Items are based on a 5-point Liker scale ranging from 1=always to 5=never. Tactile Sensitivity ranges from 7-35. Taste/Smell Sensitivity ranges from 4-20. Movement Sensitivity ranges from 3-15. Underresponsive/Seeks Sensation ranges from 7-35. Auditory Filtering ranges from 6-30. Low Energy/Weak ranges from 6-30. Visual/Auditory Sensitivity ranges from 5-25. Total scale range from 38-190. Lower scores indicate a higher probability of sensory processing abnormalities.
Time frame: Baseline and Week 12
Change in Macarthur-Bates Communicative Development Inventory (MCDI)
Macarthur-Bates Communicative Development Inventory at week 12 as compared to baseline, measuring language. Words and Gestures Forms are for children ages 8-18 months. In the form, the first part prompts parents to document the child's understanding of hundreds of early vocabulary items separated into semantic categories such as animal names, household items, and action words. Parents mark the words understood or used, and the forms yield separate indexes of words understood and words produced. The second part of each form asks parents to record the communicative and symbolic gestures the child has tried or completed. Ranges for each subscale score are as follows: Phrases understood (0-28), Words understood (0-396), Words produced (0-396), Early gestures (0-18), Later gestures (0-45), Total gestures (0-63). Higher scores indicate a great number of words, phrases, or gestures understood or produced.
Time frame: Baseline and Week 12
Change in EEG Tasks: Auditory Habituation
In the Auditory Habituation EEG task, participants listen to a series of 4 tones and the neural responses to each of these tones (event related potentials, ERPs ) are averaged. The N1 and P2 components are typical responses to auditory stimuli. The N1 response is the initial, quick response to hearing a stimulus, and P2 reflects the later processing of the stimulus. Both of these should be greater in response to the first tone, and then reduce in response to each subsequent tone. This is known as habituation, and is calculated as the change in Tone 1 minus Tone 2 response for both N1 and P2 components.
Time frame: Baseline and Week 12
Number of Adverse Events
Number of Adverse Events through week 12
Time frame: week 12
Change in Caregiver Strain Index
Mean Change Caregiver Strain Index at week 12 as compared to baseline. The Caregiver Strain Questionnaire is a 21-item measure of self-reported strain experienced by caregivers and families of youth with emotional problems, with responses on a 5-point Likert scale (0 = Not at all, 4 = very much). Full scale from 0 to 84, higher score indicates higher caregiver burden
Time frame: Baseline and Week 12
Change in Mullen Scales of Early Learning (MSEL)
Change in Mullen Scales of Early Learning (MSEL) at week 12 as compared to baseline. The Mullen Scales results are reported using Age Equivalents, which provides an estimate of the chronological age (CA) in years and months at which a typically developing child demonstrates the skills displayed by the child being assessed. The Mullen Scales results are reported using T scores. (M = 100, SD = 15). Each subscale is standardized to calculate an age-equivalent score. Higher scores represent a higher CA, and therefore better outcome.
Time frame: baseline and 12 weeks.
| Milestone | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Started | 10 | 8 |
| Completed | 7 | 7 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Milestone | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
Change in scale at week 12 as compared to baseline. Aberrant Behavior Checklist - behavior rating subscales for the assessment of treatment effects.16 items, Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). Total score range from 0 to 48, with higher score indicating poorer health outcomes.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Social Withdrawal | -7.44 ± 4.58 | -2.42 ± 3.15 |
| Irritability | -5 ± 6.63 | -1.71 ± 7.13 |
| Stereotypy | -2.22 ± 4.66 | 0.57 ± 2.99 |
| Hyperactivity | -8.11 ± 11.85 | -2.71 ± 7.34 |
| Inappropriate speech | -1.67 ± 3.04 | -7.14 ± 2.21 |
Change in VPC Task has 2 subscores at week 12 as compared to baseline. The subject is initially presented with a target for familiarization and the familiar target is then paired with a novel target. Recognition is indexed by a novelty score derived from the percentage of time looking at the novel stimulus vs. the familiar stimulus. The Social-Novel Preference score refers to the proportion of time spent looking at novel stimuli out of all the time spent looking at both novel and familiar stimuli in the social test. The Nonsocial-Novel Preference score refers to the proportion of time spent looking at novel stimuli out of all the time spent looking at both novel and familiar stimuli in the nonsocial test.The scores are given in proportions with a range from -1 to 1. A score of -1 would mean the participant shows a preference for familiar stimuli and a score of 1 demonstrates a preference for novel stimuli.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Social-Novel Preference | 0.01 ± NA | 0.02 ± 0.12 |
| Nonsocial-Novel Preference | -0.38 ± NA | 0.22 ± 0.12 |
One of three computerized eye tracking tasks to measure attention. three computer screens are set up side by side. A stimulus initially appears on the central screen, and once the participant orients to that stimulus, another stimulus will appear on one of the lateral screens. In the "gap" condition, the central stimulus will disappear before the peripheral stimulus appears. In the "overlap" condition, the central stimulus will remain on the screen while the peripheral stimulus appears. In both conditions, reaction times of the participant's eye movements (saccadic reaction time) from the central stimulus to the peripheral stimulus will be measured. Gap Effect measures the difference between average Gap and Overlap saccade latencies.
| milliseconds (ms) | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Change in Gap-Overlap Task | 63.81 ± 34.19 | — |
One of three computerized eye tracking tasks to measure attention. The "flicker task," or the four-alternative forced-choice preferential looking paradigm - the time interval over which the visual system is able to parse information. Scores range from -1 to 1 with higher scores indicating better (more typical) performance.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Preference for the Target Box at 0.2 Hz | — | 0.10 ± NA |
| Preference for the Target Box at 0.5 Hz | — | 0.30 ± NA |
| Preference for the Target Box at 1 Hz | — | -0.12 ± NA |
| Preference for the Target Box at 2 Hz | — | 0.03 ± NA |
Mean change in scale at week 12 as compared to baseline. Vineland Adaptive Behavior Communication Domain measures adaptive functioning. Vineland-II subdomains (Communication, Daily Living Skills, Socialization, Motor, Adaptive Behavior Composite, Internalizing, Externalizing and maladaptive) are V-scale scores (M=15, SD=3). Higher scores indicate better developed adaptive social behavior. Vineland-II domain and composite values are standard scores (M=100, SD=15). Higher scores indicate better developed adaptive social behavior.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Communication | 4 ± 7.72 | 2.83 ± 4.83 |
| Daily Living Skills | 3.29 ± 8.39 | 1.17 ± 5.13 |
| Socialization | 3 ± 4.86 | -0.5 ± 4.46 |
| Motor | 1 ± 3.46 | 3.17 ± 6.18 |
| Adaptive Behavior Composite | 3.14 ± 3.80 | 2 ± 3.22 |
| Internalizing | -1.14 ± 1.07 | 6 ± 0.84 |
| Externalizing | -1.14 ± 2.73 | 6 ± 1.33 |
| Maladaptive | -1.33 ± 2.42 | 6 ± 0.55 |
Change in Repetitive Behavior Scale at week 12 as compared to baseline. the RBS-R is a 44-item self-report questionnaire consisting of subscales and one additional global rating score from 1-100. Score range for Stereotypic Behavior subscale is 0-27, Self-Injurious Behavior subscale is 0-24, Compulsive Behavior subscale is 0-18, Ritualistic/Sameness Behavior subscale is 0-36, and Restricted Interests subscale 0-9. Total scale for RBS-R is 0-214, with higher score indicating more severe problem.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Stereotypic behaviors | -1.67 ± 2.78 | 0.29 ± 2.87 |
| Self-injury | -1.22 ± 3.11 | 1 ± 2.31 |
| Compulsive behaviors | -1.56 ± 3.09 | -0.14 ± 0.69 |
| Ritualistic behaviors | -1.33 ± 2.40 | -0.43 ± 1.62 |
| Sameness behaviors | -2 ± 2.65 | -0.29 ± 1.60 |
| Restrictive behaviors | -1.43 ± 2.39 | 0.14 ± 0.90 |
| Overall Score | -8.56 ± 13.29 | 0 ± 5.56 |
Mean Change in Clinical Global Impression-Severity Scales at week 12 as compared to baseline. Clinical Global Impressions (CGI) Rating Scales are commonly used to measure symptom severity and global improvement in treatment studies of patients with developmental disorders. There Severity Scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment. Full scale from 1 - 7. Higher scores indicate greater symptom severity.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Change in Clinical Global Impression - Severity Scales | -0.11 ± 0.17 | -0.1 ± 0.24 |
Mean Change in Short Sensory Profile Scale at week 12 as compared to baseline, measuring sensory sensitivity and sensory seeking behavior. The SSP is a 38-item caregiver questionnaire. Items are based on a 5-point Liker scale ranging from 1=always to 5=never. Tactile Sensitivity ranges from 7-35. Taste/Smell Sensitivity ranges from 4-20. Movement Sensitivity ranges from 3-15. Underresponsive/Seeks Sensation ranges from 7-35. Auditory Filtering ranges from 6-30. Low Energy/Weak ranges from 6-30. Visual/Auditory Sensitivity ranges from 5-25. Total scale range from 38-190. Lower scores indicate a higher probability of sensory processing abnormalities.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Tactile | 2.56 ± 5.17 | 1.57 ± 3.78 |
| Taste/Smell | 1.67 ± 2.88 | 0.71 ± 1.89 |
| Movement | -0.67 ± 2.0 | 0.29 ± 0.76 |
| Under-responsive/seeks attention | 4.44 ± 5.50 | 0.71 ± 4.68 |
| Auditory filtering | 4 ± 5.68 | 0.29 ± 5.21 |
| Low energy/weak | 1.67 ± 6.18 | -0.71 ± 4.19 |
| Visual/auditory sensitivity | 1.89 ± 2.57 | -0.86 ± 2.67 |
| Summary total | 14.33 ± 21.31 | 1 ± 17.95 |
Macarthur-Bates Communicative Development Inventory at week 12 as compared to baseline, measuring language. Words and Gestures Forms are for children ages 8-18 months. In the form, the first part prompts parents to document the child's understanding of hundreds of early vocabulary items separated into semantic categories such as animal names, household items, and action words. Parents mark the words understood or used, and the forms yield separate indexes of words understood and words produced. The second part of each form asks parents to record the communicative and symbolic gestures the child has tried or completed. Ranges for each subscale score are as follows: Phrases understood (0-28), Words understood (0-396), Words produced (0-396), Early gestures (0-18), Later gestures (0-45), Total gestures (0-63). Higher scores indicate a great number of words, phrases, or gestures understood or produced.
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Phrases understood | 0.83 ± 6.62 | 1.43 ± 3.55 |
| Words understood | -9.17 ± 52.59 | 7 ± 13.41 |
| Words produced | 11.67 ± 41.90 | 2.57 ± 10.23 |
| Early gestures | 1.83 ± 2.64 | 0.29 ± 1.38 |
| Later gestures | 3 ± 7.48 | 0.86 ± 1.95 |
| Total gestures | 4.83 ± 9.97 | 0.57 ± 2.07 |
In the Auditory Habituation EEG task, participants listen to a series of 4 tones and the neural responses to each of these tones (event related potentials, ERPs ) are averaged. The N1 and P2 components are typical responses to auditory stimuli. The N1 response is the initial, quick response to hearing a stimulus, and P2 reflects the later processing of the stimulus. Both of these should be greater in response to the first tone, and then reduce in response to each subsequent tone. This is known as habituation, and is calculated as the change in Tone 1 minus Tone 2 response for both N1 and P2 components.
| microvolts (µV) | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Auditory Habituation: N1 Habituation Change | 0.05 ± 0.37 | 0.12 ± NA |
| Auditory Habituation: P2 Habituation Change | 1.15 ± 0.91 | -3.48 ± NA |
Number of Adverse Events through week 12
| events | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Number of Adverse Events | 41 | 35 |
Mean Change Caregiver Strain Index at week 12 as compared to baseline. The Caregiver Strain Questionnaire is a 21-item measure of self-reported strain experienced by caregivers and families of youth with emotional problems, with responses on a 5-point Likert scale (0 = Not at all, 4 = very much). Full scale from 0 to 84, higher score indicates higher caregiver burden
| score on a scale | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Change in Caregiver Strain Index | -1.83 ± 1.47 | -0.86 ± 1.07 |
Change in Mullen Scales of Early Learning (MSEL) at week 12 as compared to baseline. The Mullen Scales results are reported using Age Equivalents, which provides an estimate of the chronological age (CA) in years and months at which a typically developing child demonstrates the skills displayed by the child being assessed. The Mullen Scales results are reported using T scores. (M = 100, SD = 15). Each subscale is standardized to calculate an age-equivalent score. Higher scores represent a higher CA, and therefore better outcome.
| T-score | Saline Then Oxytocin | Intranasal Oxytocin |
|---|---|---|
| Gross motor | -1.57 ± 4.69 | -0.86 ± 1.46 |
| Visual Reception | 0.29 ± 7.0 | 2.86 ± 3.30 |
| Fine Motor | -0.29 ± 1.11 | 0.71 ± 1.80 |
| Receptive Language | -1.86 ± 4.86 | 1.71 ± 2.70 |
| Expressive Language | 0.43 ± 2.61 | 0.43 ± 1.80 |
Collected over through week 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saline | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Intranasal Oxytocin | 15/15 (100%) | 0/15 (0%) | 15/15 (100%) |
| Event | Saline | Intranasal Oxytocin |
|---|---|---|
| FeverGeneral disorders | 4/10 | 9/15 |
| Restlessness/hyperactivityPsychiatric disorders | 1/10 | 8/15 |
| Sleep disturbanceGeneral disorders | 2/10 | 7/15 |
| InfectionInfections and infestations | 3/10 | 6/15 |
| Elated mood/SillinessPsychiatric disorders | 1/10 | 5/15 |
| Irritability/agitationPsychiatric disorders | 3/10 | 3/15 |
| Oppositional behaviorPsychiatric disorders | 3/10 | 2/15 |
| StereotypiesPsychiatric disorders | 2/10 | 4/15 |
| SedationGeneral disorders | 2/10 | 1/15 |
| Decreased appetiteMetabolism and nutrition disorders | 2/10 | 0/15 |
| Age, Continuous(years) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Mean | 9.8 ± 3.6 | 6.8 ± 1.4 | 8.4 ± 3.2 |
| Sex: Female, Male(Participants) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 5 | 4 | 9 |
| Race and Ethnicity Not Collected(Participants) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Aberrant Behavior Checklist Social Withdrawal (ABC-SW) subscale(units on a scale) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Mean | 20.1 ± 6.1 | 14. ± 3.4 | 17.4 ± 5.9 |
| Verbal DQ - developmental quotient(T-score) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Mean | 14.9 ± 12.8 | 26.4 ± 21.3 | 20 ± 17.6 |
| Nonverbal DQ(T-score) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Mean | 20.1 ± 11.7 | 26.1 ± 13.1 | 22.7 ± 12.3 |
| Full Scale DQ(T-score) | Saline Then Oxytocin | Intranasal Oxytocin | Total |
|---|---|---|---|
| Mean | 17.4 ± 11.8 | 26.3 ± 16.7 | 21.4 ± 14.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Apr 2016, a primary completion of Jul 2020 and a completion of Jul 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2021, 1 year 4 months after primary completion.
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Studies of the drug tested here: Oxytocin
Telomeric 22q13 Monosomy Syndrome
Alexander Kolevzon