Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
|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: NCT02423408|
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : February 17, 2017
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tension-Type Headache||Drug: TNX-201 Drug: Placebo||Phase 2|
The study will be conducted in 4 periods (the Screening Period, the Run-In Period, the Double-Blind Treatment Period and the Follow-up Period) and 4 visits (the Screening Visit, Enrollment Visit, Randomization Visit and End-of-Study Visit).
Screening Period- Eligible subjects who provide written informed consent to participate will have study assessments performed at the Screening.
Run-In Period- The Run-In Period will last for at least 28 days. During the Run-In period, subjects will be assessed for frequency of headache, study compliance and to ensure they meet all required study criteria for randomization.
Double-Blind Treatment Period- The Double-Blind Treatment Period (Treatment Period) will last up to 4 weeks or until a qualifying headache episode has occurred and been treated using the study drug, whichever occurs first.
Follow-up Period- All subjects will return to the investigational site for this visit, regardless of whether they have treated a qualifying TTH with study medication. Subjects who have not treated a qualifying TTH with study drug during the Treatment Period will be asked to return study materials and undergo safety evaluations at the End-of-Study Visit and will be discharged from the study. Subjects who have treated a qualifying TTH with study drug during the Treatment Period will ingest a 140 mg dose of open-label TNX-201 at this visit and undergo urine and blood sample collection for 3 hours post-dose to characterize each subject's genetic metabolism and PK profile.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Proof-of-Concept Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-201 for the Treatment of A Single Tension-Type Headache|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
4 X 35 mg capsules to be taken when qualifying tension-type headache occurs
Other Name: (R)-isometheptene mucate
Placebo Comparator: Placebo
4 X placebo capsules to be taken when qualifying tension-type headache occurs
Other Name: TNX-201 Placebo
- Number of Subjects Pain Free [ Time Frame: 2 hours ]
Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question).
4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; "pain-free" defined as score = 0.
VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). "Pain-free" was defined as a score <= 5
- Number of Subjects Pain Free at 15, 30, 60, 90 Minutes and 4 Hours Post-dose (Pain Will be Assessed by 4-point NRS, VAS, and Binary Yes/no Question) [ Time Frame: 15, 30, 60, 90 minutes and 4 hours post-dose ]
4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe.
VAS: 0-100 scale, No Pain vs. Worst Imaginable Headache Pain
- Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period [ Time Frame: 24-hour post-dose period ]
- Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders) [ Time Frame: 2 hours ]The Carvalho Responder analysis refers to subjects with at least 2 categories of improvement in their VAS severity category (0-100 scale). VAS severity categories were defined as "severe" if between 52-100 inclusive, "moderate" between 31-51 inclusive, "mild" between 6-30 inclusive, and pain-free if less than 6. Therefore, a Carvalho responder was either a subject who had a VAS response classified as 'severe' at baseline and 'mild' or pain-free at the post-dose assessment time point, or a subject who had a VAS response classified as 'moderate' at baseline and pain-free at the post-dose assessment time point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423408
|United States, California|
|James D. Wolfe, MD|
|San Jose, California, United States, 95117|
|United States, Florida|
|Avail Clinical Research LLC.|
|DeLand, Florida, United States, 32720|
|United States, Georgia|
|Nathan Segall, MD, CPI|
|Stockbridge, Georgia, United States, 30281|
|United States, Michigan|
|Michigan Head-Pain Neurological Institute|
|Ann Arbor, Michigan, United States, 48104|
|United States, Minnesota|
|Gary D. Berman, MD|
|Minneapolis, Minnesota, United States, 55402|
|United States, North Carolina|
|John Rubino, MD|
|Raleigh, North Carolina, United States, 27609|
|PMG Research of Winston-Salem, LLC.|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|Rapid Medical Research, Inc.|
|Cleveland, Ohio, United States, 44122|
|United States, Tennessee|
|Stephan C. Sharp, MD|
|Nashville, Tennessee, United States, 37203|
|United States, Virginia|
|Duane G. Wombolt, MD|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Tracie Ruther, M.S||1 513 579 9911 ext 2214|