Trial · NCT02197130
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
NCT02197130, Phase 2, Completed, Pfizer; results first posted 2017-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease. Trials, record NCT02197130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02197130
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
- NCT number
- NCT02197130
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 272 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Huntington's Disease
- Interventions
- PF-02545920, PF-02545920, Placebo
- First posted
- 2014-07-22
- Last updated
- 2017-11-17
- Other registries' IDs
- eudract:2014-001291-56
- Results first posted
- 2017-11-17
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment. | Baseline, Week 26 | The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) 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. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. 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 | Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | The criteria for temporary study suspension was as follow: Criterion A: WBC count \<=3000 cells/mm3 but \>= 2000 cells/mm3 or ANC \<= 1500 cells/mm3 but \>= 1000 cells/mm3; Criterion B: WBC \<= 2000 cells/mm3 or ANC \<= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC \<= 500 cells/mm3 |
| Secondary | Number of Participants With Adverse Events | Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Number of Participants With Serious Adverse Events | Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. |
| Secondary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities) | Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], urine specific gravity, glucose, protein, blood, ketones, nitrite). |
| Secondary | Number of Participants With Laboratory Test Abnormalities (With Normal Baseline) | Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], urine specific gravity, glucose, protein, blood, ketones, nitrite). |
| Secondary | Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values) | Screening, Day 1, 28, 91, and 182 | Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (\<) 90 millimeter of mercury(mmHg); Criterion B: standing SBP \< 90 mmHg; Criterion C: supine DBP \<50 mmHg; Criterion D: standing DBP \<50 mmHg; Criterion E: supine pulse rate \< 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (\>)120 BPM; Criterion G: standing pulse rate \< 40 beats per minute(BPM); Criterion H: standing pulse rate \>120 BPM; |
| Secondary | Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline) | Screening, Day 1, 28, 91, and 182 | The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (\>=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP \>= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP \>=20 mmHg; Criterion D: maximum increase from baseline in standing DBP \>=20 mmHg |
| Secondary | Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline) | Screening, Day 1, 28, 91, and 182 | The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP \>= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP \>= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP \>=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP \>=20 mmHg |
| Secondary | Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values) | Screening, Day 1, 28, 91, and 182 | The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) \>=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) \>=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-\<480 msec; Criterion D: maximum QTcF interval 480-\<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) \>=500 msec |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment. | Baseline, Week 26 | All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values. | units on a scale | MEAN |
| SECONDARY | Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events | Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities) | Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities (With Normal Baseline) | Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192) | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values) | Screening, Day 1, 28, 91, and 182 | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline) | Screening, Day 1, 28, 91, and 182 | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline) | Screening, Day 1, 28, 91, and 182 | All participants with at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values) | Screening, Day 1, 28, 91, and 182 | All participants with at least one dose of study medication. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group147
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment. | PF-02545920 20 mg BID | 0.4 | Standard Deviation 8.63 | units on a scale | |
| Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment. | PF-02545920 5 mg BID | -0.8 | Standard Deviation 7.30 | units on a scale | |
| Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment. | Placebo | -1.4 | Standard Deviation 6.67 | units on a scale | |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | PF-02545920 20 mg BID | Criterion A | 0 | 8.63 | participants |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | PF-02545920 5 mg BID | Criterion A | 1 | 7.30 | participants |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | Placebo | Criterion A | 0 | 6.67 | participants |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | PF-02545920 20 mg BID | Criterion B | 0 | participants | |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | PF-02545920 5 mg BID | Criterion B | 0 | participants | |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | Placebo | Criterion B | 0 | participants | |
| Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria | PF-02545920 20 mg BID | Criterion C | 0 | participants |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-02545920 5 mg BID | 95 | |
| Overall Study | STARTED | Placebo | 89 | |
| Overall Study | STARTED | PF-02545920 20 mg BID | 88 | |
| Overall Study | Received Treatment | PF-02545920 5 mg BID | 95 | |
| Overall Study | Received Treatment | Placebo | 88 | |
| Overall Study | Received Treatment | PF-02545920 20 mg BID | 87 | |
| Overall Study | COMPLETED | PF-02545920 5 mg BID | 79 | |
| Overall Study | COMPLETED | Placebo | 81 | |
| Overall Study | COMPLETED | PF-02545920 20 mg BID | 56 | |
| Overall Study | NOT COMPLETED | PF-02545920 5 mg BID | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events126
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 | PF-02545920 5 mg BID | 7 | 95 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 88 | |
| other | Diarrhoea | Gastrointestinal disorders | PF-02545920 20 mg BID | 7 | 87 | |
| other | Dry mouth | Gastrointestinal disorders | PF-02545920 5 mg BID | 1 | 95 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 88 | |
| other | Dry mouth | Gastrointestinal disorders | PF-02545920 20 mg BID | 6 | 87 | |
| other | Nausea | Gastrointestinal disorders | PF-02545920 5 mg BID | 12 | 95 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 88 | |
| other | Nausea | Gastrointestinal disorders | PF-02545920 20 mg BID | 11 | 87 | |
| other | Vomiting | Gastrointestinal disorders | PF-02545920 5 mg BID | 10 | 95 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-02545920 5 mg BID | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PF-02545920 20 mg BID | ||
| Total, other adverse events | PF-02545920 5 mg BID | 71 | 95 |
| Total, other adverse events | Placebo | 42 | 88 |
| Total, other adverse events | PF-02545920 20 mg BID | 65 | 87 |
| Total, serious adverse events | PF-02545920 5 mg BID | 2 | 95 |
| Total, serious adverse events | Placebo | 7 | 88 |
| Total, serious adverse events | PF-02545920 20 mg BID | 8 | 87 |
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/NCT02197130
GET https://conductscience.org/api/trials/v1/NCT02197130/results?page=2