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Trial record 21 of 67 for:    "narcolepsy"

A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy

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ClinicalTrials.gov Identifier: NCT01006122
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Excessive Daytime Sleepiness
Narcolepsy
Interventions: Drug: Placebo
Drug: PF-03654746

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PF-03654746 First, Then Placebo PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
Placebo First Then, PF-03654746 Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.

Participant Flow for 3 periods

Period 1:   First Double-blind Intervention Period
    PF-03654746 First, Then Placebo   Placebo First Then, PF-03654746
STARTED   47   48 
COMPLETED   31   31 
NOT COMPLETED   16   17 
Lost to Follow-up                0                2 
Protocol Violation                1                1 
Pregnancy                0                1 
Withdrawal by Subject                9                8 
Does not meet entrance criteria                1                0 
Lack of Efficacy                2                1 
Other                3                0 
Adverse Event                0                4 

Period 2:   Wash-out Period (at Least 7 Days)
    PF-03654746 First, Then Placebo   Placebo First Then, PF-03654746
STARTED   31   31 
COMPLETED   31   31 
NOT COMPLETED   0   0 

Period 3:   Second Double-blind Intervention Period
    PF-03654746 First, Then Placebo   Placebo First Then, PF-03654746
STARTED   31   31 
COMPLETED   29   24 
NOT COMPLETED   2   7 
Adverse Event                1                1 
Protocol Violation                1                0 
Lost to Follow-up                0                3 
Withdrawal by Subject                0                2 
Death                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug.

Reporting Groups
  Description
Entire Study Included all participants randomized to receive PF-03654746 first and placebo first.

Baseline Measures
   Entire Study 
Overall Participants Analyzed 
[Units: Participants]
 95 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.1  (10.3) 
Gender 
[Units: Participants]
 
Female   58 
Male   37 


  Outcome Measures

1.  Primary:   Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase   [ Time Frame: Baseline, Day 21 of stable dosing phase ]

2.  Secondary:   Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase ]

3.  Secondary:   Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase ]

4.  Secondary:   Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase   [ Time Frame: Baseline, Day 7, 14, 21 of stable dosing phase ]

5.  Secondary:   Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase   [ Time Frame: Baseline, Day 21 of stable dosing phase ]

6.  Secondary:   Clinical Global Impression of Improvement (CGI-I) Scale Score   [ Time Frame: Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase ]

7.  Secondary:   Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase ]

8.  Secondary:   Computer Based Objective Cognition Testing (CogState) Detection Speed   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase ]

9.  Secondary:   Computer Based Objective Cognition Testing (CogState) Identification Speed   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase ]

10.  Secondary:   Computer Based Objective Cognition Testing (CogState) One Card Learning   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase ]

11.  Secondary:   Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase ]

12.  Secondary:   Computer Based Objective Cognition Testing (CogState ) Composite Score   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase ]

13.  Other Pre-specified:   Number of Participants With Vital Signs Data   [ Time Frame: Baseline up to 7-10 days after Day 21 (stable dosing phase) ]

14.  Other Pre-specified:   Number of Participants With Laboratory Abnormalities   [ Time Frame: Baseline up to Day 21 of stable dosing phase ]

15.  Other Pre-specified:   Number of Participants With Electrocardiogram (ECG) Findings   [ Time Frame: Baseline up to Day 21 of stable dosing phase ]

16.  Other Pre-specified:   Medical Outcomes Study (MOS) Sleep Scale Score   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase ]

17.  Other Pre-specified:   Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)   [ Time Frame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01006122     History of Changes
Other Study ID Numbers: A8801015
First Submitted: October 29, 2009
First Posted: November 2, 2009
Results First Submitted: April 8, 2014
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014