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Staccato Prochlorperazine in Migraine (in Clinic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00610428
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Migraine Headache, With or Without Aura
Interventions: Drug: Staccato Placebo
Drug: Staccato Prochlorperazine 5 mg
Drug: Staccato Prochlorperazine 10 mg

  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
Inhaled Placebo

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled PCZ 5 mg

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled PCZ 10 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg


Participant Flow:   Overall Study
    Inhaled Placebo   Inhaled PCZ 5 mg   Inhaled PCZ 10 mg
STARTED   24   24   27 
COMPLETED   24   23   25 
NOT COMPLETED   0   1   2 



  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.
Safety Population

Reporting Groups
  Description
Inhaled Placebo

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled PCZ 5 mg

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled PCZ 10 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg

Total Total of all reporting groups

Baseline Measures
   Inhaled Placebo   Inhaled PCZ 5 mg   Inhaled PCZ 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   27   75 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      24 100.0%      24 100.0%      27 100.0%      75 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (11.4)   43.6  (10.8)   41.9  (10.1)   43.5  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      15  62.5%      20  83.3%      23  85.2%      58  77.3% 
Male      9  37.5%      4  16.7%      4  14.8%      17  22.7% 
Region of Enrollment 
[Units: Participants]
       
United States   24   24   27   75 


  Outcome Measures

1.  Primary:   Headache Pain Relief at 2 hr Post-dose by 2-point Definition   [ Time Frame: 2 hours after treatment ]

2.  Secondary:   Survival Analysis for Time to Pain Relief   [ Time Frame: from treatment (time = 0) to 2 hours post treatment ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Executive VP, Research & Development, Regulatory & Quality
Organization: Alexza Pharmaceuticals, Inc
phone: 650.944.7071
e-mail: ClinicalTrialsInfo@alexza.com


Publications:

Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00610428     History of Changes
Other Study ID Numbers: AMDC-001-201
First Submitted: January 28, 2008
First Posted: February 8, 2008
Results First Submitted: February 7, 2017
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018