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A trial to study the effect of a medicine, "Rivastigmine" for memory loss in a disease of the Central Nervous System "Multiple Sclerosis"

Rivastigmine for Cognitive Impairment in Multiple Sclerosis : A Parallel Group Randomised Open Label study with Blinded End point Assessment

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018291
Enrollment
120
Registered
2019-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G00-G09- Inflammatory diseases of the central nervous system

Interventions

Intervention1: TAB RIVASTIGMINE: 1.5 mg BD for 4 weeks followed by 3 mg BD for 12 weeks ( total 16 weeks) Control Intervention1: NOT APPLICABLE: CONTROL ARM WILL RECEIVE NO TREATMENT

Sponsors

AMRITA GOTUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent to participate in the trial. 2. Males and Females between 18 yrs and 65 yrs of age 3. Definite diagnosis of Multiple Sclerosis as defined by 2017 Revised Mc Donald Criteria 4. Sufficient education to read, write and communicate comprehensibly.

Exclusion criteria

Exclusion criteria: -Relapse in the recent 2 months -Presence of systemic disease affecting cognition ( stroke, head trauma, PD), -Presence of neuropsychiatric conditions affecting cognition ( major depression ), -Those who refuse consent -Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Improvement in memory performance as assessed by logical memory subset of welscher memory scale III ( India)Timepoint: baseline , 16 weeks

Secondary

MeasureTime frame
1. effect on fatigue using modified fatigue impact scale (mFIS V) 2. Effect on depression using Montgomery Asberg Depression rating scale. 3. Safety ( side effects ) of Rivastigmine.Timepoint: baseline, 16 weeks

Countries

India

Contacts

Public ContactDr Amrita Jagdish Gotur

Dept of Neurology, AIIMS, New Delhi

amritauno@gmail.com7701870355

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026