Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine

This study has been completed.
Sponsor:
Collaborator:
Clinvest
Information provided by (Responsible Party):
Tian Medical Inc.
ClinicalTrials.gov Identifier:
NCT01709708
First received: October 16, 2012
Last updated: November 12, 2014
Last verified: November 2014
Results First Received: July 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Migraine
Interventions: Drug: Marcaine
Drug: Saline

  Participant Flow
  Hide 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
Marcaine

Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)

Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.

Saline Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.

Participant Flow:   Overall Study
    Marcaine     Saline  
STARTED     27     14  
COMPLETED     26     12  
NOT COMPLETED     1     2  
Protocol Violation                 1                 2  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Marcaine

Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)

Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.

Saline Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
Total Total of all reporting groups

Baseline Measures
    Marcaine     Saline     Total  
Number of Participants  
[units: participants]
  27     14     41  
Age  
[units: years]
Mean ± Standard Deviation
  40.96  ± 11.63     41.97  ± 14.71     41.30  ± 12.59  
Gender  
[units: participants]
     
Female     20     11     31  
Male     7     3     10  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     0     4  
White     20     14     34  
More than one race     3     0     3  
Unknown or Not Reported     0     0     0  



  Outcome Measures

1.  Primary:   Numeric Rating Scale (NRS)   [ Time Frame: Estimated 6 Weeks ]

2.  Secondary:   Change in Numeric Rating Scale (NRS)   [ Time Frame: Estimated 6 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Patient's Global Impression of Change (PGIC)   [ Time Frame: Estimated 6 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Modified Pain Characteristic Questionnaire   [ Time Frame: 6 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Migraine Headache Days   [ Time Frame: Estimated 14 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Acute Medications Usage   [ Time Frame: Estimated 10 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Adverse Events   [ Time Frame: Estimated 14 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Headache Impact Test (HIT-6)   [ Time Frame: Estimated 10 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Overall Satisfaction   [ Time Frame: Estimated 10 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Roger Cady
Organization: Clinvest/A Division of Banyan Group Inc.
phone: 417-883-7889
e-mail: rcady@banyangroupinc.com


Publications of Results:
Other Publications:


Responsible Party: Tian Medical Inc.
ClinicalTrials.gov Identifier: NCT01709708     History of Changes
Other Study ID Numbers: 12-004TI
Study First Received: October 16, 2012
Results First Received: July 24, 2014
Last Updated: November 12, 2014
Health Authority: United States: Institutional Review Board