Trial · NCT00931164
Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)
NCT00931164, Phase 1, Phase 2, Completed, University of Utah; results first posted 2014-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO). Trials, record NCT00931164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00931164
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)
- NCT number
- NCT00931164
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Alternating Hemiplegia of Childhood
- Interventions
- Sodium Oxybate
- First posted
- 2009-07-02
- Last updated
- 2014-03-31
- Results first posted
- 2014-03-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Duration of AHC Episodes | Week 7 | |
| Primary | Observed Safety Data During 5-day Hospitalization for Drug Dose Identification | Week 7 | |
| Primary | Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase | 1 year | |
| Secondary | Mean Daily Percentage of Time That Functional Status is Affected Due to Episodes | Week 14 | |
| Secondary | Quality of Life Questionnaires | Week 14 | |
| Secondary | Mood and Behavior Questionnaires | Week 14 | |
| Secondary | Functional Skills Questionnaires | Week 14 | |
| Secondary | Neuropsychological Tests | Week 14 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Duration of AHC Episodes | Week 7 | |||
| PRIMARY | Observed Safety Data During 5-day Hospitalization for Drug Dose Identification | Week 7 | |||
| PRIMARY | Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase | 1 year | participants | NUMBER | |
| SECONDARY | Mean Daily Percentage of Time That Functional Status is Affected Due to Episodes | Week 14 | |||
| SECONDARY | Quality of Life Questionnaires | Week 14 | |||
| SECONDARY | Mood and Behavior Questionnaires | Week 14 | |||
| SECONDARY | Functional Skills Questionnaires | Week 14 | |||
| SECONDARY | Neuropsychological Tests | Week 14 |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase | Sodium Oxybate | 4 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Oxybate | 6 | |
| Overall Study | COMPLETED | Sodium Oxybate | 6 | |
| Overall Study | NOT COMPLETED | Sodium Oxybate | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Desaturation | Respiratory, thoracic and mediastinal disorders | Sodium Oxybate | 1 | 6 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Sodium Oxybate | 2 | 6 | 2 |
| other | Otitis Media | Infections and infestations | Sodium Oxybate | 1 | 6 | 1 |
| other | Vomiting | Gastrointestinal disorders | Sodium Oxybate | 2 | 6 | 2 |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Sodium Oxybate | 3 | 6 | 4 |
| other | Heat Rash | General disorders | Sodium Oxybate | 2 | 6 | 2 |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Sodium Oxybate | 1 | 6 | 1 |
| other | Fever | General disorders | Sodium Oxybate | 1 | 6 | 2 |
| serious | Loss of consciousness/vomit event | Gastrointestinal disorders | Sodium Oxybate | 1 | 6 | 2 |
| serious | Respiratory Distress Event | Respiratory, thoracic and mediastinal disorders | Sodium Oxybate | 1 | 6 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Oxybate | ||
| Total, other adverse events | Sodium Oxybate | 6 | 6 |
| Total, serious adverse events | Sodium Oxybate | 1 | 6 |
Source ClinicalTrials.gov
Papers39
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00931164
GET https://conductscience.org/api/trials/v1/NCT00931164/papers?page=2