Trial Outcomes & Findings for Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache (NCT NCT02423408)

Last Updated: 2017-04-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

165 participants

Primary outcome timeframe

2 hours

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	TNX-201 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule
Overall Study STARTED	83	82
Overall Study COMPLETED	82	80
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TNX-201 n=83 Participants 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo n=82 Participants 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule	Total n=165 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	83 Participants n=5 Participants	82 Participants n=7 Participants	165 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: LOCF Analysis 8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses.

Outcome measures

Outcome measures
Measure	TNX-201 n=75 Participants 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo n=72 Participants 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule
Number of Subjects Pain Free Binary Response	21 Participants	20 Participants
Number of Subjects Pain Free 4-Point NRS	21 Participants	19 Participants
Number of Subjects Pain Free VAS	20 Participants	21 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	TNX-201 n=75 Participants 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo n=72 Participants 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule
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) Binary Response : 15 Minutes	1 Participants	0 Participants
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) Binary Response : 30 Minutes	4 Participants	2 Participants
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) Binary Response : 60 Minutes	9 Participants	8 Participants
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) Binary Response : 90 Minutes	13 Participants	17 Participants
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) Binary Response : 4 Hours	37 Participants	37 Participants
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) 4-Point NRS : 15 Minutes	1 Participants	0 Participants
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) 4-Point NRS : 30 Minutes	3 Participants	1 Participants
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) 4-Point NRS : 60 Minutes	8 Participants	7 Participants
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) 4-Point NRS : 90 Minutes	13 Participants	14 Participants
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) 4-Point NRS : 4 Hours	37 Participants	35 Participants
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) VAS : 15 Minutes	2 Participants	0 Participants
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) VAS : 30 Minutes	4 Participants	2 Participants
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) VAS : 60 Minutes	8 Participants	5 Participants
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) VAS : 90 Minutes	13 Participants	13 Participants
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) VAS : 4 Hours	39 Participants	34 Participants

SECONDARY outcome

Timeframe: 24-hour post-dose period

Population: 8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses.

Outcome measures

Outcome measures
Measure	TNX-201 n=75 Participants 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo n=72 Participants 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule
Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period	16 Participants	15 Participants

SECONDARY outcome

Timeframe: 2 hours

Population: Only subjects who were categorized as "severe" or "moderate" at baseline and have data reported at 2 hours were included in this analysis. All subjects who took rescue medication at or before 2 hours were considered non-responders.

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.

Outcome measures

Outcome measures
Measure	TNX-201 n=56 Participants 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo n=60 Participants 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule
Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders)	24 Participants	24 Participants

Adverse Events

TNX-201

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TNX-201 n=78 participants at risk 4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs TNX-201: TNX-201 capsule	Placebo n=73 participants at risk 4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs Placebo: Placebo capsule
Nervous system disorders Dizziness	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Gastrointestinal disorders Abdominal discomfort	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
General disorders Chills	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Gastrointestinal disorders Dry Mouth	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
General disorders Malaise	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
General disorders Pyrexia	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Nervous system disorders Somnolence	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Infections and infestations Upper Respiratory Tract Infection	1.3% 1/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	0.00% 0/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
General disorders Feeling Hot	0.00% 0/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Vascular disorders Flushing	0.00% 0/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Infections and infestations Nasopharyngitis	0.00% 0/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Cardiac disorders Palpitations	0.00% 0/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.
Infections and infestations Sinusitis	0.00% 0/78 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.	1.4% 1/73 5 subjects in the TNX-201 group and 9 subjects in the placebo group did not take a dose of study drug during the double-blind treatment period; therefore, these subjects were not included in the analyses.

Additional Information

Judith Gendreau, Senior Medical Director

Tonix Pharmaceuticals

Phone: 858-433-5574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee An industry standard NDA in place with all study investigators.
Publication restrictions are in place

Restriction type: OTHER