Trial · NCT05228834
Voxelotor Neurocognitive Function Study
NCT05228834, Phase 3, Terminated, Pfizer; results first posted 2024-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Voxelotor Neurocognitive Function Study. Trials, record NCT05228834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05228834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Voxelotor Neurocognitive Function Study
- NCT number
- NCT05228834
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sickle Cell Disease
- Interventions
- Voxelotor Only Product in Oral Dose Form, Placebo
- First posted
- 2022-02-08
- Last updated
- 2024-05-02
- Results first posted
- 2024-05-02
- Limitations and caveats
- The study was terminated due to slow enrollment and resource reprioritization at L-GBT. Based on the low enrolment data was not reported due to risk of re-identification of participant.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Executive Abilities Composite Score Assessed Using NIH Toolbox Cognition Module At Week 12 | Baseline (last assessment prior to first dose of study treatment), Week 12 | The NIH toolbox cognition module is a standardized cognitive battery comprising of executive function, episodic memory, language, processing speed, working memory, and attention as subdomains. The toolbox is comprised of 7 test instruments that measure 8 abilities within 6 major cognitive domains and have been categorized as executive abilities (Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Test) and nonexecutive abilities (Picture Vocabulary Test, Oral Reading Recognition Test, and Picture Sequence Memory Test). The NIH toolbox standard score has a mean of 100 and standard deviation (SD) of 15. The higher the score, the better the performance. |
| Secondary | Change From Baseline in Pattern Comparison Processing Speed Test Scores Assessed Using NIH Toolbox Cognition Module at Week 12 | Baseline (last assessment prior to first dose of study treatment), Week 12 | The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10. |
| Secondary | Change From Baseline in Nonexecutive Cognitive Abilities Composite Score Assessed Using NIH Toolbox Cognition Module Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | The NIH toolbox cognition module is a standardized cognitive battery comprising of executive function, episodic memory, language, processing speed, working memory, and attention as subdomains. The toolbox is currently comprised of 7 test instruments that measure 8 abilities within 6 major cognitive domains and have been categorized as executive abilities (Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Test) and nonexecutive abilities (Picture Vocabulary Test, Oral Reading Recognition Test, and Picture Sequence Memory Test). Baseline was defined as the last assessment performed prior to receiving the first dose of study treatment. The NIH toolbox standard score has a mean of 100 and SD of 15. The higher the score, the better the performance. |
| Secondary | Change From Baseline in Hemoglobin Level Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | |
| Secondary | Change From Baseline in Absolute Reticulocyte Count Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | |
| Secondary | Change From Baseline in Percentage Reticulocyte Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | |
| Secondary | Change From Baseline in Lactate Dehydrogenase (LDH) Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | |
| Secondary | Change From Baseline in Unconjugated Bilirubin Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | |
| Secondary | Percent Change From Baseline in Unconjugated Bilirubin, Absolute Reticulocyte, Percentage Reticulocytes, Lactate Dehydrogenase (LDH) Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study treatment (Day 1) up to Week 12 | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in participants whether or not considered drug related. TEAEs were those events with onset dates that occurred during the treatment period. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Executive Abilities Composite Score Assessed Using NIH Toolbox Cognition Module At Week 12 | Baseline (last assessment prior to first dose of study treatment), Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Pattern Comparison Processing Speed Test Scores Assessed Using NIH Toolbox Cognition Module at Week 12 | Baseline (last assessment prior to first dose of study treatment), Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Nonexecutive Cognitive Abilities Composite Score Assessed Using NIH Toolbox Cognition Module Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Hemoglobin Level Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Percentage Reticulocyte Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Lactate Dehydrogenase (LDH) Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Change From Baseline in Unconjugated Bilirubin Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| SECONDARY | Percent Change From Baseline in Unconjugated Bilirubin, Absolute Reticulocyte, Percentage Reticulocytes, Lactate Dehydrogenase (LDH) Up to Week 12 | Baseline (last assessment prior to first dose of study treatment) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study treatment (Day 1) up to Week 12 | Study was terminated and only one participant was enrolled. Hence, data cannot be reported for this outcome measure due to risk of re-identification of participant. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voxelotor | 0 | |
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | COMPLETED | Voxelotor | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Voxelotor | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voxelotor | 0 | 0 |
| Total, all-cause mortality | Placebo | 0 | 0 |
| Total, other adverse events | Voxelotor | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Voxelotor | 0 | 0 |
| Total, serious adverse events | Placebo | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Dimensional Change Card Sort | Primary outcome | ConductCognition |
| Picture Order Memory Test | Primary outcome | ConductCognition |
| Size Order Memory Test | Primary outcome | ConductCognition |
| Vocabulary Test | Primary outcome | ConductCognition |
| Pattern and Letter Comparison | Secondary outcome | ConductCognition |
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/NCT05228834
GET https://conductscience.org/api/trials/v1/NCT05228834/registered