Trial · NCT02342548
Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
NCT02342548, Phase 2, Terminated, Pfizer; results first posted 2018-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021. Trials, record NCT02342548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02342548
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
- NCT number
- NCT02342548
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 188 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Huntington's Disease
- Interventions
- 20 mg BID of PF-02545920
- First posted
- 2015-01-21
- Last updated
- 2018-04-23
- Other registries' IDs
- eudract:2014-004900-31
- Results first posted
- 2018-04-23
- Limitations and caveats
This study was terminated on 15 December 2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 and placebo. No safety concerns were associated with this termination.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 1 year | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. |
| Primary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 1 year | The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin \[diabetics only\], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy \[human chorionic gonadotropin, hCG\], serum beta hCG). Abnormality was determined by the investigator. |
| Primary | Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | 1 year | Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); (2) standing SBP \<90 mmHg; (3) supine diastolic blood pressure (DBP) \<50 mmHg; (4) standing DBP \<50 mmHg; (5) supine pulse rate \<40 beats per minute (bpm); (6) supine pulse rate \>120 bpm; (7) standing pulse rate \<40 bpm; (8) standing pulse rate \>140 bpm; (9) maximum increase from baseline in supine SBP \>= 30 mmHg; (10) maximum increase from baseline in standing SBP \>= 30 mmHg; (11) maximum increase from baseline in supine DBP \>= 20 mmHg; (12) maximum increase from baseline in standing DBP \>= 20 mmHg; (13) maximum decrease from baseline in supine SBP \>=30 mmHg; (14) maximum decrease from baseline in standing SBP \>=30 mmHg; (15) maximum decrease from baseline in supine DBP \>=20 mmHg; (16) maximum decrease from baseline in standing DBP \>=20 mmHg. |
| Primary | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | 1 year | Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval \>=300 msec; (2) QRS complex \>=140 msec; (3) QTcF interval: 450 to \<480 msec; (4) QTcF interval: 480 to \<500 msec; (5) QTcF interval \>=500 msec; (6) PR interval increase from baseline \>=25/50 percent; (7) QRS complex increase from baseline \>=50 percent; (8) QTcF interval increase from baseline: 30 to \<60 msec; (9) QTcF interval increase from baseline \>=60 msec. |
| Primary | Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality) | 1 year | Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count \<0.6 \*the lower limit of normal (LLN); (2) WBC count \>1.5 times the upper limit of normal (ULN); (3) ANC \<0.8\*LLN; and (4) ANC \>1.2\*ULN. |
| Primary | Number of Participants With Laboratory Test Abnormalities (Normal Baseline) | 1 year | The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin \[diabetics only\], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy \[human chorionic gonadotropin, hCG\], serum beta hCG). Abnormality was determined by the investigator. |
| Primary | Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity | 1 year | Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function. |
| Primary | Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category | Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12) | Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent). |
| Secondary | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score | Baseline (Day 1), Month 6, and Month 12 | The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington's disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Motor Score (TMS) assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural ability. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124. |
| Secondary | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score | Baseline (Day 1), Month 6, and Month 12 | The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington's disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Maximum Chorea (TMC) is a subset of the TMS assessment, and composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment is rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 1 year | Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 1 year | Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | 1 year | The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | 1 year | The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality) | 1 year | The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities (Normal Baseline) | 1 year | Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity | 1 year | Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category | Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12) | The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score | Baseline (Day 1), Month 6, and Month 12 | Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took \>=1 dose of open-label study medication. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score | Baseline (Day 1), Month 6, and Month 12 | Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took \>=1 dose of open-label study medication. | Units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group264
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 20 mg PF-02545920 | AEs | 39 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 5 mg PF-02545920 Titration up to 20 mg | AEs | 63 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | Placebo and Titration up to 20 mg PF-02545920 | AEs | 62 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 20 mg PF-02545920 | SAEs | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 5 mg PF-02545920 Titration up to 20 mg | SAEs | 9 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | Placebo and Titration up to 20 mg PF-02545920 | SAEs | 5 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 20 mg PF-02545920 | 19 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 5 mg PF-02545920 Titration up to 20 mg | 27 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Placebo and Titration up to 20 mg PF-02545920 | 28 | Participants | ||
| Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | 20 mg PF-02545920 | Supine SBP <90 mmHg | 0 | Participants |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 20 mg PF-02545920 | 51 | |
| Overall Study | STARTED | 5 mg PF-02545920 Titration up to 20 mg | 71 | |
| Overall Study | STARTED | Placebo and Titration up to 20 mg PF-02545920 | 66 | |
| Overall Study | COMPLETED | 20 mg PF-02545920 | 17 | |
| Overall Study | COMPLETED | 5 mg PF-02545920 Titration up to 20 mg | 9 | |
| Overall Study | COMPLETED | Placebo and Titration up to 20 mg PF-02545920 | 23 | |
| Overall Study | NOT COMPLETED | 20 mg PF-02545920 | 34 | |
| Overall Study | NOT COMPLETED | 5 mg PF-02545920 Titration up to 20 mg | 62 | |
| Overall Study | NOT COMPLETED | Placebo and Titration up to 20 mg PF-02545920 | 43 |
Source ClinicalTrials.gov
Adverse events141
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 | Diarrhoea | Gastrointestinal disorders | 20 mg PF-02545920 | 2 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | 5 mg PF-02545920 Titration up to 20 mg | 6 | 71 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo and Titration up to 20 mg PF-02545920 | 4 | 66 | |
| other | Dysphagia | Gastrointestinal disorders | 20 mg PF-02545920 | 2 | 51 | |
| other | Dysphagia | Gastrointestinal disorders | 5 mg PF-02545920 Titration up to 20 mg | 3 | 71 | |
| other | Dysphagia | Gastrointestinal disorders | Placebo and Titration up to 20 mg PF-02545920 | 4 | 66 | |
| other | Nausea | Gastrointestinal disorders | 20 mg PF-02545920 | 2 | 51 | |
| other | Nausea | Gastrointestinal disorders | 5 mg PF-02545920 Titration up to 20 mg | 9 | 71 | |
| other | Nausea | Gastrointestinal disorders | Placebo and Titration up to 20 mg PF-02545920 | 8 | 66 | |
| other | Vomiting | Gastrointestinal disorders | 20 mg PF-02545920 | 1 | 51 |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20 mg PF-02545920 | 0 | 51 |
| Total, all-cause mortality | 5 mg PF-02545920 Titration up to 20 mg | 0 | 71 |
| Total, all-cause mortality | Placebo and Titration up to 20 mg PF-02545920 | 0 | 66 |
| Total, other adverse events | 20 mg PF-02545920 | 32 | 51 |
| Total, other adverse events | 5 mg PF-02545920 Titration up to 20 mg | 53 | 71 |
| Total, other adverse events | Placebo and Titration up to 20 mg PF-02545920 | 54 | 66 |
| Total, serious adverse events | 20 mg PF-02545920 | 7 | 51 |
| Total, serious adverse events | 5 mg PF-02545920 Titration up to 20 mg | 9 | 71 |
| Total, serious adverse events | Placebo and Titration up to 20 mg PF-02545920 | 5 | 66 |
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.
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/NCT02342548
GET https://conductscience.org/api/trials/v1/NCT02342548/results?page=2