Trial Outcomes & Findings for Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses (NCT NCT03752307)

NCT ID: NCT03752307

Last Updated: 2024-02-06

Results Overview

Vital Signs: Blood pressure greater than 140/90, pulse greater than 110 and temperature greater than 37.8 Celsius.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2024-02-06

Participant Flow

Participant milestones

Measure	Corticosteroid & Isoxsuprine HCL Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive days and Isoxsuprine Hydrochloride one 10 mg Capsule 3 times daily for 5 consecutive days Isoxsuprine Hydrochloride: Compounded Isoxsuprine hydrochloride capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon	Corticosteroid & Placebo Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive day and placebo one Capsule 3 times daily for 5 consecutive days Placebo: Identical microcrystalline cellulose placebo manufactured to mimic Isoxsuprine Hydrochloride 10 MG capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses

Baseline characteristics by cohort

Measure	Corticosteroid & Isoxsuprine HCL n=1 Participants Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive days and Isoxsuprine Hydrochloride one 10 mg Capsule 3 times daily for 5 consecutive days Isoxsuprine Hydrochloride: Compounded Isoxsuprine hydrochloride capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon	Corticosteroid & Placebo n=1 Participants Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive day and placebo one Capsule 3 times daily for 5 consecutive days Placebo: Identical microcrystalline cellulose placebo manufactured to mimic Isoxsuprine Hydrochloride 10 MG capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon	Total n=2 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25 years n=5 Participants	26 years n=7 Participants	25.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Vital Signs: Blood pressure greater than 140/90, pulse greater than 110 and temperature greater than 37.8 Celsius.

Outcome measures

Measure	Corticosteroid & Isoxsuprine HCL n=1 Participants Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive days and Isoxsuprine Hydrochloride one 10 mg Capsule 3 times daily for 5 consecutive days Isoxsuprine Hydrochloride: Compounded Isoxsuprine hydrochloride capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon	Corticosteroid & Placebo n=1 Participants Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive day and placebo one Capsule 3 times daily for 5 consecutive days Placebo: Identical microcrystalline cellulose placebo manufactured to mimic Isoxsuprine Hydrochloride 10 MG capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon
Incidence of Treatment-Emergent Adverse Events in Subjects by Measuring Measuring Changes in Vital Signs	0 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: Baseline to Week 12

The unit of measure is 0 (no disability) to 10 (death). An increase in EDSS score from baseline measure during with steroid/study treatment during the study would be considered an adverse event.

Outcome measures

Measure	Corticosteroid & Isoxsuprine HCL n=1 Participants Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive days and Isoxsuprine Hydrochloride one 10 mg Capsule 3 times daily for 5 consecutive days Isoxsuprine Hydrochloride: Compounded Isoxsuprine hydrochloride capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon	Corticosteroid & Placebo n=1 Participants Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive day and placebo one Capsule 3 times daily for 5 consecutive days Placebo: Identical microcrystalline cellulose placebo manufactured to mimic Isoxsuprine Hydrochloride 10 MG capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon
Incidence of Adverse Event Expanded Disability Status Scale (EDSS)	0 Adverse Events	0 Adverse Events

Adverse Events

Corticosteroid & Isoxsuprine HCL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Corticosteroid & 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

Measure	Corticosteroid & Isoxsuprine HCL n=1 participants at risk Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive days and Isoxsuprine Hydrochloride one 10 mg Capsule 3 times daily for 5 consecutive days Isoxsuprine Hydrochloride: Compounded Isoxsuprine hydrochloride capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon	Corticosteroid & Placebo n=1 participants at risk Corticosteroid pulse of either daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon for 3 to 5 consecutive day and placebo one Capsule 3 times daily for 5 consecutive days Placebo: Identical microcrystalline cellulose placebo manufactured to mimic Isoxsuprine Hydrochloride 10 MG capsules Corticosteroid: This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon
Gastrointestinal disorders Heart burn and Nausea	100.0% 1/1 • Number of events 1 • Adverse events were collected during the 12 week study duration. Any serious adverse events that occurred were followed until they had resolved or stabilized. Adverse events were not related to the study drug and did not occur in an unanticipated manner.	0.00% 0/1 • Adverse events were collected during the 12 week study duration. Any serious adverse events that occurred were followed until they had resolved or stabilized. Adverse events were not related to the study drug and did not occur in an unanticipated manner.

Additional Information

Corey Ford, M.D., Ph.D.

University of New Mexico

Phone: 505-925-4124

Email: cford@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place