Trial Outcomes & Findings for Natalizumab and Chronic Inflammation (NCT NCT05177718)

Results Overview

To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

12 months

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Single Arm SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV Natalizumab 300 MG in 15 ML Injection: Disease modifying agent
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Natalizumab and Chronic Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Single Arm n=1 Participants SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV Natalizumab 300 MG in 15 ML Injection: Disease modifying agent
Age, Customized 46	1 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Data analysis was not completed because only one participant completed (each arm) and disclosing data could violate privacy interests.

To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Data analysis is not reported because only one participant completed (each arm) and disclosing data could violate privacy interests.

To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To explore changes in QoL measurements and the relations between these changes and those seen in ktrans and natalizumab serum levels.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Single Arm

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

Natalizumab and chronic Blood Brain Barrier Breakdown

Vumc

Phone: 6159360060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place