Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD) (NCT NCT05081167)

Last Updated: 2024-03-26

Results Overview

Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

232 participants

Primary outcome timeframe

Day 28

Results posted on

2024-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	REL-1017 A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. REL-1017: REL-1017 tablet	Placebo Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. Placebo: Placebo tablet
Overall Study STARTED	116	116
Overall Study COMPLETED	108	102
Overall Study NOT COMPLETED	8	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REL-1017 25 mg n=116 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. REL-1017: REL-1017 tablet	Placebo n=116 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. Placebo: Placebo tablet	Total n=232 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 13.0 • n=5 Participants	38.7 years STANDARD_DEVIATION 12.9 • n=7 Participants	37.4 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	71 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	45 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	36 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	78 Participants n=7 Participants	146 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	84 Participants n=7 Participants	165 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and were assessed for the primary efficacy endpoint at both Baseline and Day 28

Outcome measures

Outcome measures
Measure	REL-1017 25 mg n=105 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. REL-1017: REL-1017 tablet	Placebo n=100 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. Placebo: Placebo tablet
Change in the MADRS10 Total Score From Baseline to Day 28	-14.8 score on a scale Standard Deviation 12.4	-13.9 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Day 28

Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and had the Baseline assessment of the primary efficacy endpoint performed

Therapeutic remission rate with REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Remission is defined as MADRS10 Total Score ≤10 at Day 28. A higher percentage of remission indicates a higher percentage of subjects with MADRS10 Total Score ≤10 at Day 28.

Outcome measures

Outcome measures
Measure	REL-1017 25 mg n=116 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. REL-1017: REL-1017 tablet	Placebo n=116 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. Placebo: Placebo tablet
MADRS10 Remission Rate (Total Score ≤10) at Day 28	21.6 percentage of participants in remission Interval 15.0 to 29.9	16.4 percentage of participants in remission Interval 10.7 to 24.2

SECONDARY outcome

Timeframe: Day 28

Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and had the Baseline assessment of the primary efficacy endpoint performed

Therapeutic response to REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Response rate is defined as an improvement ≥50% compared with total Baseline MADRS10 score

Outcome measures

Outcome measures
Measure	REL-1017 25 mg n=116 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. REL-1017: REL-1017 tablet	Placebo n=116 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. Placebo: Placebo tablet
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28	38.8 percentage of responders Interval 30.4 to 47.9	34.5 percentage of responders Interval 26.5 to 43.5

Adverse Events

REL-1017 25 mg

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	REL-1017 25 mg n=116 participants at risk A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. REL-1017: REL-1017 tablet	Placebo n=116 participants at risk Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. Placebo: Placebo tablet
Nervous system disorders Headache	11.2% 13/116 • Number of events 20 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	9.5% 11/116 • Number of events 11 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Nausea	9.5% 11/116 • Number of events 12 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	5.2% 6/116 • Number of events 6 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Dizziness	8.6% 10/116 • Number of events 11 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	4.3% 5/116 • Number of events 7 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations COVID-19	9.5% 11/116 • Number of events 11 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	2.6% 3/116 • Number of events 3 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
General disorders Fatigue	5.2% 6/116 • Number of events 6 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	3.4% 4/116 • Number of events 4 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Dry mouth	5.2% 6/116 • Number of events 7 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	2.6% 3/116 • Number of events 3 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Upper respirator tract infection	1.7% 2/116 • Number of events 2 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	6.0% 7/116 • Number of events 7 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.

Additional Information

Marco Pappagallo, MD

Relmada Therapeutics

Phone: 786-638-7384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place