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Trial record 1 of 1 for:    NCT02332798
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Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia (MAD)

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ClinicalTrials.gov Identifier: NCT02332798
Recruitment Status : Completed
First Posted : January 7, 2015
Results First Posted : June 14, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: PF-04958242
Drug: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14. All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14. All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Period Title: Overall Study
Started 13 14 12
Completed 12 12 11
Not Completed 1 2 1
Reason Not Completed
Unwilling to Participate in Study             0             1             1
Positive Urine Drug Test             0             1             0
Abnormal Laboratory Findings             1             0             0
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo Total
Hide Arm/Group Description All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14. All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14. All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14. Total of all reporting groups
Overall Number of Baseline Participants 13 14 12 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 12 participants 39 participants
45.6  (5.9) 41.6  (7.5) 45.8  (10.5) 44.3  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 12 participants 39 participants
Female
0
   0.0%
3
  21.4%
2
  16.7%
5
  12.8%
Male
13
 100.0%
11
  78.6%
10
  83.3%
34
  87.2%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) (Single Dose)
Hide Description [Not Specified]
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
1.920
(23%)
3.830
(21%)
2.Primary Outcome
Title Cmax (Steady State)
Hide Description Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
3.174
(18%)
7.139
(37%)
3.Primary Outcome
Title Time for Cmax (Tmax) (Single Dose)
Hide Description [Not Specified]
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14
Median (Full Range)
Unit of Measure: hours
1.65
(1.00 to 2.00)
1.33
(0.167 to 3.00)
4.Primary Outcome
Title Tmax (Steady State)
Hide Description Tmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: hours
1.65
(1.00 to 2.00)
1.33
(0.50 to 4.00)
5.Primary Outcome
Title Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)
Hide Description [Not Specified]
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hours per milliliter (ng*h/mL)
9.570
(19%)
17.72
(18%)
6.Primary Outcome
Title AUCτ (Steady State)
Hide Description AUCτ steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
24.57
(19%)
50.09
(34%)
7.Primary Outcome
Title Apparent Oral Clearance (CL/F) (Steady State)
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter per minute (mL/min)
169.5
(18%)
157.9
(34%)
8.Primary Outcome
Title Apparent Volume of Distribution (Vz/F) (Steady State)
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter (L)
545.7
(31%)
530.2
(26%)
9.Primary Outcome
Title Terminal Half-Life (t1/2) (Steady State)
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half. t1/2 steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: hours
39.64  (14.878) 42.18  (14.421)
10.Primary Outcome
Title Observed Accumulation Ratio (Rac) (Steady State)
Hide Description Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1). Rac steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 (ie. X = 14) were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
2.524
(20%)
2.815
(31%)
11.Primary Outcome
Title Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State)
Hide Description Accumulation ratio based on Cmax was calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose. Rac, Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.645
(23%)
1.797
(51%)
12.Primary Outcome
Title Peak-to-Trough Ratio at Steady State (PTR)
Hide Description PTR was calculated as Cmax divided by Cmin (that is defined as lowest concentration observed during the dosing interval). PTR steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Time Frame Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
2.323
(19%)
2.531
(28%)
13.Primary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Measurements
Hide Description The following laboratory parameters were reported: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, phosphorus, cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), bicarbonate, uric acid, albumin, and total protein); urinalysis (color, appearance, specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], and urine drug screening).
Time Frame Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
4 4 7
14.Primary Outcome
Title Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Hide Description Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<) 40 or greater than (>) 120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.
Time Frame Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
Supine SBP <90 mmHg 0 2 0
Standing SBP <90 mmHg 0 1 0
Supine SBP >=30 mmHg IFB 0 0 1
Standing SBP >=30 mmHg IFB 2 1 1
Supine DBP >=20 mmHg IFB 0 2 1
Standing DBP >=20 mmHg IFB 2 2 0
Supine SBP >=30 mmHg DFB 2 1 0
Standing SBP >=30 mmHg DFB 2 1 1
Supine DBP >=20 mmHg DFB 2 0 3
Standing DBP >=20 mmHg DFB 5 2 4
15.Primary Outcome
Title Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern
Hide Description Electrocardiogram (ECG) parameters included beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, and QTc using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and and QTcF >=450 to <480, 480 to <500 and >=500 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Time Frame Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
0 0 0
16.Primary Outcome
Title Number of Participants With Abnormalities in Neurological Examination
Hide Description The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).
Time Frame Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
0 0 0
17.Primary Outcome
Title Number of Participants With Abnormalities in Physical Examination
Hide Description A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Time Frame Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
0 0 0
18.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time Frame Baseline up to 28 days after last study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
AEs 10 9 4
SAEs 0 0 0
19.Primary Outcome
Title Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Time Frame Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of the study medication.
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description:
All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Overall Number of Participants Analyzed 13 14 12
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame Baseline up to 28 days after last study drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Hide Arm/Group Description All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14. All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14. All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
All-Cause Mortality
PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-04958242 0.25 mg PF-04958242 0.475 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/13 (76.92%)   9/14 (64.29%)   4/12 (33.33%) 
Ear and labyrinth disorders       
Tinnitus * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
Eye disorders       
Eye pain * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/13 (0.00%)  2/14 (14.29%)  0/12 (0.00%) 
Constipation * 1  1/13 (7.69%)  2/14 (14.29%)  0/12 (0.00%) 
Diarrhoea * 1  0/13 (0.00%)  1/14 (7.14%)  1/12 (8.33%) 
Dry mouth * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
Dyspepsia * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Flatulence * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
Gastrooesophageal reflux disease * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Nausea * 1  1/13 (7.69%)  4/14 (28.57%)  1/12 (8.33%) 
Vomiting * 1  0/13 (0.00%)  3/14 (21.43%)  0/12 (0.00%) 
General disorders       
Nodule * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Oedema peripheral * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
Pain * 1  1/13 (7.69%)  0/14 (0.00%)  0/12 (0.00%) 
Infections and infestations       
Folliculitis * 1  1/13 (7.69%)  0/14 (0.00%)  0/12 (0.00%) 
Upper respiratory tract infection * 1  3/13 (23.08%)  0/14 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications       
Fall * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Muscle strain * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms * 1  1/13 (7.69%)  0/14 (0.00%)  0/12 (0.00%) 
Muscle tightness * 1  1/13 (7.69%)  0/14 (0.00%)  0/12 (0.00%) 
Musculoskeletal chest pain * 1  1/13 (7.69%)  0/14 (0.00%)  0/12 (0.00%) 
Musculoskeletal stiffness * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Pain in extremity * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
Nervous system disorders       
Dizziness * 1  0/13 (0.00%)  1/14 (7.14%)  2/12 (16.67%) 
Headache * 1  4/13 (30.77%)  4/14 (28.57%)  2/12 (16.67%) 
Somnolence * 1  3/13 (23.08%)  2/14 (14.29%)  2/12 (16.67%) 
Tremor * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Psychiatric disorders       
Abnormal dreams * 1  1/13 (7.69%)  1/14 (7.14%)  0/12 (0.00%) 
Anxiety * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Insomnia * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Nightmare * 1  0/13 (0.00%)  1/14 (7.14%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders       
Eczema * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
Rash papular * 1  0/13 (0.00%)  0/14 (0.00%)  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Biogen Study Medical Director
Organization: Biogen
Phone: 866-633-4636
EMail: clinicaltrials@biogen.com
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02332798    
Other Study ID Numbers: B1701017
MAD ( Other Identifier: Alias Study Number )
First Submitted: December 5, 2014
First Posted: January 7, 2015
Results First Submitted: March 2, 2016
Results First Posted: June 14, 2016
Last Update Posted: January 9, 2020