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

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ClinicalTrials.gov Identifier: NCT01709708
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : October 20, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Clinvest
Information provided by (Responsible Party):
Tian Medical Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chronic Migraine
Interventions: Drug: Marcaine
Drug: Saline

  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

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 
Overall Participants Analyzed 
[Units: Participants]
 27   14   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.96  (11.63)   41.97  (14.71)   41.30  (12.59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  74.1%      11  78.6%      31  75.6% 
Male      7  25.9%      3  21.4%      10  24.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4  14.8%      0   0.0%      4   9.8% 
White      20  74.1%      14 100.0%      34  82.9% 
More than one race      3  11.1%      0   0.0%      3   7.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

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

2.  Secondary:   Change in Numeric Rating Scale (NRS)   [ Time Frame: 15 Minutes Post Treatment, 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks ]

3.  Secondary:   Patient's Global Impression of Change (PGIC)   [ Time Frame: 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks ]

4.  Secondary:   Modified Pain Characteristic Questionnaire   [ Time Frame: Before Treatment, 24 Hours After Treatment, 1 Month Post Treatment, and 6 Months Post Treatment ]

5.  Secondary:   Migraine Headache Days   [ Time Frame: 12 Weeks ]

6.  Secondary:   Acute Medications Usage   [ Time Frame: 10 Weeks ]

7.  Secondary:   Adverse Events   [ Time Frame: 34 weeks ]

8.  Secondary:   Headache Impact Test (HIT-6)   [ Time Frame: 10 Weeks ]

9.  Secondary:   Overall Satisfaction   [ Time Frame: 10 Weeks ]


  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 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: Jim Sly
Organization: Clinvest Research
phone: 4178413673
e-mail: jsly@clinvest.com


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tian Medical Inc.
ClinicalTrials.gov Identifier: NCT01709708     History of Changes
Other Study ID Numbers: 12-004TI
First Submitted: October 16, 2012
First Posted: October 18, 2012
Results First Submitted: July 24, 2014
Results First Posted: October 20, 2014
Last Update Posted: January 26, 2018