Trial Outcomes & Findings for An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache (NCT NCT04860713)

Results Overview

Change of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

60 minutes

Results posted on

2024-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	AOK Group Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin aspirin and ketamine: Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin	Nurtec (Rimegepant) Group Drug: 75 mg of ODT Nurtec (Rimegepant): Drug: 75 mg of ODT
Overall Study STARTED	4	1
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AOK Group n=4 Participants Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin aspirin and ketamine: Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin	Nurtec (Rimegepant) Group n=1 Participants Drug: 75 mg of ODT Nurtec (Rimegepant): Drug: 75 mg of ODT	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	1 Participants n=1 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=4 Participants	1 Participants n=1 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=4 Participants	0 Participants n=1 Participants	1 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 60 minutes

Change of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.

Outcome measures

Outcome measures
Measure	AOK Group n=4 Participants Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin aspirin and ketamine: Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin	Nurtec (Rimegepant) Group n=1 Participants Drug: 75 mg of ODT Nurtec (Rimegepant): Drug: 75 mg of ODT
Change in Pain Score at 60 Minutes	4 score on a scale Interval 0.0 to 8.0	5 score on a scale Interval 5.0 to 5.0

Adverse Events

AOK Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nurtec (Rimegepant) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Administration Director

Maimonides Medical Center

Phone: 718-283-6896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place