Trial Outcomes & Findings for A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine (NCT NCT06848075)

Results Overview

Assessed using the number of evaluable participants that reported no pain at 2 hours post-dose. Pain was measured on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

431 participants

Primary outcome timeframe

2 hours post-dose

Results posted on

2026-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Elismetrep (K-304) 2 mg Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg Participants received a single dose of elismetrep 20 mg	Placebo Participants received a single dose of elismetrep-matched placebo
Overall Study STARTED	54	107	108	54	108
Overall Study COMPLETED	54	106	106	54	106
Overall Study NOT COMPLETED	0	1	2	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Elismetrep (K-304) 2 mg Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg Participants received a single dose of elismetrep 20 mg	Placebo Participants received a single dose of elismetrep-matched placebo
Overall Study Lost to Follow-up	0	1	2	0	2

Baseline Characteristics

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo	Total n=398 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	0 Participants n=106 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	9 Participants n=31 Participants	24 Participants n=49 Participants	10 Participants n=80 Participants	7 Participants n=29 Participants	17 Participants n=106 Participants	67 Participants n=6 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 10.13 • n=31 Participants	44.5 years STANDARD_DEVIATION 13.12 • n=49 Participants	46.1 years STANDARD_DEVIATION 12.68 • n=80 Participants	47.4 years STANDARD_DEVIATION 13.96 • n=29 Participants	46.5 years STANDARD_DEVIATION 11.44 • n=106 Participants	45.8 years STANDARD_DEVIATION 12.36 • n=6 Participants
Sex: Female, Male Female	43 Participants n=31 Participants	89 Participants n=49 Participants	86 Participants n=80 Participants	44 Participants n=29 Participants	84 Participants n=106 Participants	346 Participants n=6 Participants
Sex: Female, Male Male	8 Participants n=31 Participants	12 Participants n=49 Participants	10 Participants n=80 Participants	7 Participants n=29 Participants	15 Participants n=106 Participants	52 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants	0 Participants n=49 Participants	1 Participants n=80 Participants	0 Participants n=29 Participants	1 Participants n=106 Participants	2 Participants n=6 Participants
Race (NIH/OMB) Asian	2 Participants n=31 Participants	2 Participants n=49 Participants	2 Participants n=80 Participants	1 Participants n=29 Participants	4 Participants n=106 Participants	11 Participants n=6 Participants
Race (NIH/OMB) White	40 Participants n=31 Participants	71 Participants n=49 Participants	81 Participants n=80 Participants	43 Participants n=29 Participants	74 Participants n=106 Participants	309 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants	2 Participants n=49 Participants	2 Participants n=80 Participants	0 Participants n=29 Participants	1 Participants n=106 Participants	5 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	2 Participants n=49 Participants	0 Participants n=80 Participants	0 Participants n=29 Participants	2 Participants n=106 Participants	4 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=31 Participants	11 Participants n=49 Participants	11 Participants n=80 Participants	6 Participants n=29 Participants	12 Participants n=106 Participants	45 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=31 Participants	89 Participants n=49 Participants	84 Participants n=80 Participants	44 Participants n=29 Participants	87 Participants n=106 Participants	350 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	1 Participants n=49 Participants	1 Participants n=80 Participants	1 Participants n=29 Participants	0 Participants n=106 Participants	3 Participants n=6 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating) and provided baseline and at least one post-baseline efficacy data point

Assessed using the number of evaluable participants that reported no pain at 2 hours post-dose. Pain was measured on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
Pain Freedom	4 Participants	10 Participants	10 Participants	9 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating) and provided baseline and at least one post-baseline efficacy data point. Participants reporting an MBS at baseline were analyzed.

Assessed using the number of evaluable participants that reported the absence of their MBS

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=44 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=95 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=87 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=47 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=95 Participants Participants received a single dose of elismetrep-matched placebo
Freedom From the Most Bothersome Symptom (MBS) (Nausea, Phonophobia or Photophobia)	12 Participants	38 Participants	28 Participants	18 Participants	23 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point.

Assessed using the number of evaluable participants that reported a pain level of moderate or severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then reported a pain level of none or mild (response of 0 or 1).

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
Pain Relief	29 Participants	56 Participants	50 Participants	30 Participants	42 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point. Participants who reported presence of photophobia at baseline were analyzed.

Assessed by tabulating the number of participants that reported the absence of photophobia at 2 hours post-dose in the subset of participants that reported the presence of photophobia at baseline.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=40 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=80 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=75 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=40 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=88 Participants Participants received a single dose of elismetrep-matched placebo
Freedom From Photophobia	11 Participants	23 Participants	18 Participants	13 Participants	26 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point. Participants who reported phonophobia at baseline were analyzed.

Assessed by tabulating the number of participants that reported the absence of phonophobia at 2 hours post-dose in the subset of participants that reported the presence of phonophobia at baseline.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=32 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=68 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=59 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=29 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=70 Participants Participants received a single dose of elismetrep-matched placebo
Freedom From Phonophobia	12 Participants	29 Participants	23 Participants	11 Participants	22 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point. Participants who reported nausea at baseline were analyzed.

Assessed by tabulating the number of participants that reported the absence of nausea at 2 hours post-dose in the subset of participants that reported the presence of nausea at baseline.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=22 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=44 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=38 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=26 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=43 Participants Participants received a single dose of elismetrep-matched placebo
Freedom From Nausea	12 Participants	25 Participants	24 Participants	13 Participants	23 Participants

SECONDARY outcome

Timeframe: 24 hours post-dose

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point.

Assessed using the number of participants that took rescue medication within 24 hours after administration of study therapy

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
The Probability of Requiring Rescue Medication	15 Participants	24 Participants	25 Participants	16 Participants	27 Participants

SECONDARY outcome

Timeframe: From 2 to 24 hours

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point.

Assessed using the number of participants that did not experience any headache pain through the time period of interest

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
Sustained Pain Freedom	2 Participants	7 Participants	10 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: From 2 to 24 hours

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point.

Assessed using the number of participants that did not experience any moderate or severe headache pain through the time period of interest.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
Sustained Pain Relief	19 Participants	39 Participants	34 Participants	15 Participants	26 Participants

SECONDARY outcome

Timeframe: From 2 to 48 hours

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point.

Assessed using the number of participants that did not experience any headache pain through the time period of interest.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
Sustained Pain Freedom	2 Participants	6 Participants	8 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: From 2 to 48 hours

Population: Modified ITT Set including randomized participants who took study therapy, had a qualifying migraine of moderate or severe baseline pain intensity (Grade 2 or 3, on a 4-point numeric rating), and provided baseline and at least one post-baseline efficacy data point.

Assessed using the number of participants that did not experience any moderate or severe headache pain through the time period of interest.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=96 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=99 Participants Participants received a single dose of elismetrep-matched placebo
Sustained Pain Relief	16 Participants	35 Participants	29 Participants	14 Participants	21 Participants

SECONDARY outcome

Timeframe: up to 7 days after administration of study therapy

Population: Safety Analysis Set: All randomized participants who took study therapy.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=97 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=104 Participants Participants received a single dose of elismetrep-matched placebo
Proportion of Participants Who Experienced 1 or More Treatment-emergent Adverse Events (AEs)	3 Participants	8 Participants	18 Participants	21 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 7 days after administration of study therapy

Population: Safety Analysis Set: All randomized participants who took study therapy.

Serious adverse events were assessed in the Safety Analysis Set.

Outcome measures

Outcome measures
Measure	Elismetrep (K-304) 2 mg n=51 Participants Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 Participants Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=97 Participants Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 Participants Participants received a single dose of elismetrep 20 mg	Placebo n=104 Participants Participants received a single dose of elismetrep-matched placebo
Proportion of Participants Who Experienced 1 or More Treatment-emergent Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Elismetrep (K-304) 2 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Elismetrep (K-304) 5 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Elismetrep (K-304) 10 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Elismetrep (K-304) 20 mg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Elismetrep (K-304) 2 mg n=51 participants at risk Participants received a single dose of elismetrep 2 mg	Elismetrep (K-304) 5 mg n=101 participants at risk Participants received a single dose of elismetrep 5 mg	Elismetrep (K-304) 10 mg n=97 participants at risk Participants received a single dose of elismetrep 10 mg	Elismetrep (K-304) 20 mg n=51 participants at risk Participants received a single dose of elismetrep 20 mg	Placebo n=104 participants at risk Participants received a single dose of elismetrep-matched placebo
General disorders Feeling hot	0.00% 0/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/101 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	4.1% 4/97 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	9.8% 5/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/104 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.
Vascular disorders Hot flush	0.00% 0/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/101 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	1.0% 1/97 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	7.8% 4/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/104 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.
Vascular disorders Flushing	3.9% 2/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.99% 1/101 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	4.1% 4/97 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	5.9% 3/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/104 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.
Nervous system disorders Paresthesia	0.00% 0/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/101 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	5.2% 5/97 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	7.8% 4/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/104 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.
Gastrointestinal disorders Paresthesia oral	0.00% 0/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/101 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	2.1% 2/97 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	9.8% 5/51 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.	0.00% 0/104 • Up to 7 days after administration of study therapy Mortality, AEs and SAEs were assessed in the Safety Analysis Set which was all randomized participants who took study therapy.

Additional Information

Clinical Director

Kallyope, Inc

Phone: 917-336-3279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER