Trial · NCT01281969
Intravenous Immunoglobulin for PANDAS
NCT01281969, Phase 3, Completed, National Institute of Mental Health (NIMH); results first posted 2020-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intravenous Immunoglobulin for PANDAS. Trials, record NCT01281969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01281969
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravenous Immunoglobulin for PANDAS
- NCT number
- NCT01281969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 48 participants, actual
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Conditions
- Obsessive-Compulsive Disorder, Children, Anxiety Disorder, Autoimmune Disease, PANDAS
- Interventions
- Gamunex Intravenous Immunoglobulin, Placebo
- First posted
- 2011-01-24
- Last updated
- 2020-03-17
- Results first posted
- 2020-03-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Children's Yale-Brown Obsessive Compulsive Scale Total Score | 6 weeks | Active IVIG will be significantly superior to sham IVIG in reducing OC symptoms and providing global relief of neuropsychiatric symptomatology. Total score is reported as the sum of all items and has a range of 0-40. Higher scores indicate more severe symptoms. |
| Secondary | Clinical Global Impressions Improvement | 6 weeks | 1=very much improved, 2=much improved, 3=slightly improved, 4=no change, 5=slightly worse, 6=much worse, 7=very much worse |
| Secondary | Clinical Responder to Treatment | 6 weeks | Defined as a CGI-I score of 1 or 2 ("much" or "very much" improved) and a decrease in CY-BOCS of at least 30% |
| Secondary | The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration. | Baseline | Non-zero values of antinuclear antibodies are considered "positive" and reflective of an ongoing immune response in the individual. First, the number of participants who were classified at baseline as having "positive" antinuclear antibodies was calculated (see outcome measure data table, which states the number (AKA "count") of participants who had "positive" antinuclear antibodies at baseline). We hypothesized that improvement in the ongoing immune response, and therefore a reduction in antinuclear antibody titers, would mediate the effect of IVIG on OCD symptom improvement. However, because very few participants were classified as "positive" at baseline, it was not appropriate to pursue the original question of whether a decline in antinuclear antibodies (i.e., from "positive" to "negative") was related to symptom improvement. |
| Secondary | The Degree of Treatment Response is Also Expected to Correlate With Decreased Inflammation in Specific Regions of the Brain, as Demonstrated by Changes on MRI | 3 Months |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Children's Yale-Brown Obsessive Compulsive Scale Total Score | 6 weeks | units on a scale | MEAN | |
| SECONDARY | Clinical Global Impressions Improvement | 6 weeks | units on a scale | MEAN | |
| SECONDARY | Clinical Responder to Treatment | 6 weeks | participants | NUMBER | |
| SECONDARY | The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration. | Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Degree of Treatment Response is Also Expected to Correlate With Decreased Inflammation in Specific Regions of the Brain, as Demonstrated by Changes on MRI | 3 Months |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Children's Yale-Brown Obsessive Compulsive Scale Total Score | Group A | 20.59 | Standard Deviation 10.12 | units on a scale | |
| Children's Yale-Brown Obsessive Compulsive Scale Total Score | Group B | 25.67 | Standard Deviation 8.65 | units on a scale | |
| Clinical Global Impressions Improvement | Group A | 2.88 | Standard Deviation 1.20 | units on a scale | |
| Clinical Global Impressions Improvement | Group B | 3.53 | Standard Deviation 1.62 | units on a scale | |
| Clinical Responder to Treatment | Group A | 6 | participants | ||
| Clinical Responder to Treatment | Group B | 4 | participants | ||
| The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration. | IVIG | 8 | Participants | ||
| The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration. | Placebo | 5 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IVIG | 18 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | STARTED | Screened But Not Randomized | 12 | |
| Overall Study | COMPLETED | IVIG | 17 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | Screened But Not Randomized | 0 | |
| Overall Study | NOT COMPLETED | IVIG | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Screened But Not Randomized | 12 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Group A | 8 | 17 | |
| other | Headache | General disorders | Group B | 3 | 18 | |
| other | Sore throat | General disorders | Group A | 1 | 17 | |
| other | Sore throat | General disorders | Group B | 2 | 18 | |
| other | Stomach or abdominal discomfort | General disorders | Group A | 3 | 17 | |
| other | Stomach or abdominal discomfort | General disorders | Group B | 1 | 18 | |
| other | Nausea (vomiting) | General disorders | Group A | 4 | 17 | |
| other | Nausea (vomiting) | General disorders | Group B | 1 | 18 | |
| other | Muscle/bone/joint pain | General disorders | Group A | 3 | 17 | |
| other | Muscle/bone/joint pain | General disorders | Group B | 2 | 18 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | ||
| Total, all-cause mortality | Group B | ||
| Total, other adverse events | Group A | 17 | 17 |
| Total, other adverse events | Group B | 5 | 18 |
| Total, serious adverse events | Group A | 0 | 17 |
| Total, serious adverse events | Group B | 0 | 18 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IVIG vs Placebo: The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration. | Trial comparisons |
| Group A vs Group B: Clinical Responder to Treatment | Trial comparisons |
| Group A vs Group B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01281969
GET https://conductscience.org/api/trials/v1/NCT01281969/registered