Trial · NCT01233609
Trial of Oral Valproic Acid for Retinitis Pigmentosa
NCT01233609, Phase 2, Completed, Foundation Fighting Blindness; results first posted 2017-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Oral Valproic Acid for Retinitis Pigmentosa. Trials, record NCT01233609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01233609
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Oral Valproic Acid for Retinitis Pigmentosa
- NCT number
- NCT01233609
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Foundation Fighting Blindness
- Conditions
- Retinitis Pigmentosa
- Interventions
- Valproic Acid, Placebo
- First posted
- 2010-11-03
- Last updated
- 2017-12-02
- Results first posted
- 2017-12-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter | baseline to week 52 | Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the III4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model |
| Secondary | Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter | baseline to week 52 | Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the I4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model |
| Secondary | Static Perimetry by Treatment Arm--Full Field Hill of Vision | baseline to week 52 | Mean change from baseline at week 52 for Full field Hill of Vision (Static perimetry) |
| Secondary | Static Perimetry Volume--30 Degree Hill of Vision | baseline to week 52 | Mean Change from baseline to week 52 for Static Perimetry Volume --30 Degree Hill of Vision. Full field static perimetry protocol was followed using the Octopus 900 (Haag-Streit) for a single session for each eye. |
| Secondary | Mean Change From Baseline in Best Corrected Visual Acuity | baseline to week 52 | Mean change in best corrected visual acuity as assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) method from baseline to week 52 |
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 | Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter | baseline to week 52 | The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed. | Visual field area (degrees squared) | MEAN |
| SECONDARY | Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter | baseline to week 52 | The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed. | Visual field area (degrees squared) | MEAN |
| SECONDARY | Static Perimetry by Treatment Arm--Full Field Hill of Vision | baseline to week 52 | The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed. | db-steridians | MEAN |
| SECONDARY | Static Perimetry Volume--30 Degree Hill of Vision | baseline to week 52 | The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed. | db-steridans | MEAN |
| SECONDARY | Mean Change From Baseline in Best Corrected Visual Acuity | baseline to week 52 | The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed. | letters read correctly | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter | Placebo--Right Eye | -122.9 | Standard Deviation 543.60 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter | Placebo--Left Eye | -112.0 | Standard Deviation 584.63 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter | Valproic Acid--Right Eye | -293.7 | Standard Deviation 736.56 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter | Valproic Acid--Left Eye | -237.1 | Standard Deviation 691.76 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter | Placebo--Right Eye | 80.9 | Standard Deviation 406.2 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter | Placebo--Left Eye | 115.7 | Standard Deviation 696.89 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter | Valproic Acid--Right Eye | 5.3 | Standard Deviation 759.46 | Visual field area (degrees squared) | |
| Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter | Valproic Acid--Left Eye | 19.5 | Standard Deviation 703.83 | Visual field area (degrees squared) | |
| Static Perimetry by Treatment Arm--Full Field Hill of Vision | Placebo--Right Eye | -0.3 | Standard Deviation 2.55 | db-steridians | |
| Static Perimetry by Treatment Arm--Full Field Hill of Vision | Placebo--Left Eye | -1.4 | Standard Deviation 3.27 | db-steridians |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valproic Acid | 46 | |
| Overall Study | STARTED | Placebo | 44 | |
| Overall Study | COMPLETED | Valproic Acid | 37 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | NOT COMPLETED | Valproic Acid | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events50
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 | Nasopharyngitis | Infections and infestations | Placebo | 9 | 44 | |
| other | Nasopharyngitis | Infections and infestations | Valproic Acid | 3 | 46 | |
| other | Sinusitis | Infections and infestations | Placebo | 3 | 44 | |
| other | Sinusitis | Infections and infestations | Valproic Acid | 7 | 46 | |
| other | Influenza | Infections and infestations | Placebo | 7 | 44 | |
| other | Influenza | Infections and infestations | Valproic Acid | 1 | 46 | |
| other | Bronchitis | Infections and infestations | Placebo | 0 | 44 | |
| other | Bronchitis | Infections and infestations | Valproic Acid | 3 | 46 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 44 | |
| other | Nausea | Gastrointestinal disorders | Valproic Acid | 8 | 46 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 44 |
| Total, all-cause mortality | Valproic Acid | 1 | 46 |
| Total, other adverse events | Placebo | 41 | 44 |
| Total, other adverse events | Valproic Acid | 45 | 46 |
| Total, serious adverse events | Placebo | 2 | 44 |
| Total, serious adverse events | Valproic Acid | 3 | 46 |
Source ClinicalTrials.gov
Papers20
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Valproic Acid vs Placebo: deaths from any cause | Trial comparisons |
| Valproic Acid vs Placebo: 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/NCT01233609
GET https://conductscience.org/api/trials/v1/NCT01233609/events?page=2