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Study on Combination Drug Therapy in Human MS Patients
Researchers are conducting a trial with 250 MS patients to assess the effect of a combination of drugs on disability progression, measured by the CombiWISE scale, over 1.5 years. The primary endpoint is the change in CombiWISE progression rate compared to baseline.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
This study may provide insights into the effects of new drug combinations on MS progression, potentially influencing future treatment strategies.
What this does not prove
No results have been posted yet as the study is ongoing with recruitment still in process and the primary endpoint not reported.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 250 · Estimated
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
Supporting passages (11)
study design"studyType": "INTERVENTIONAL"
subjects"eligibilityCriteria": "* INCLUSION CRITERIA:\n* Enrolled in 09-I-0032 protocol.\n* Clinically definite MS.\n* Age \\>=18 years at time of study enrollment.\n* Expanded Disability Status Scale (EDSS) 1.0-7.5.\n* For progressive MS cohort enrollment:\n\n * Documented sustained clinical progression of at least 0.5 CombiWISE points/year on stable therapy (or untreated)\n\n * If follow-up is \\<3 years, CombiWISE progression slopes are measured by \\>= 4 time points regression analysis of CombiWISE values spanning at least 18 months (1.5 years)\n * If follow-up is \\>=3 years, CombiWISE progression slopes are measured by \\>= 2 time-points regression analysis of CombiWISE values spanning at least 36 months (3 years)\n * Because currently only NDS utilizes CombiWISE scale, the progression slopes will be determined via 09-I-0032 natural history protocol that contains completely overlapping procedures.\n * It is possible that after other MS centers start using CombiWISE scale, this progression criterion may be derived from outside data, as long as they are adequately documented.\n* For non-progressing MS with residual disability cohort enrollment:\n\n * CombiWISE slope on stable therapy (derived identically as in progressive MS cohort) \\>0 and \\<0.5 CombiWISE units/year (i.e., neurological deficit that is no longer improving)\n * CombiWISE at the end of screening period \\>10 (i.e., sustained residual disability)\n* Women who can become pregnant must be willing to use a medically acceptable form of birth control, while being treated on this study.\n* Patients on current FDA-approved DMTs will be enrolled with the understanding that the underlying FDA-approved therapy must remain stable during this protocol.
sample size"count": 250, "type": "ESTIMATED"
sample size basis"type": "ESTIMATED"
randomized"allocation": "NON_RANDOMIZED"
regulatory approval"isFdaRegulatedDrug": false, "isFdaRegulatedDevice": false
intervention"interventionNames": [ "Drug: Cilostazol", "Drug: Leucovorin", "Drug: Pirfenidone", "Drug: Dantrolene", "Drug: Pioglitazone" ]
primary endpoint"measure": "Primary outcome will be change in CombiWISE progression rate at the end of monotherapy plus combination therapy period in comparison to projected baseline disability progression."
follow up"timeFrame": "1.5 years"
findings"Primary outcome will be change in CombiWISE progression rate at the end of monotherapy plus combination therapy period in comparison to projected baseline disability progression."
limitationsPlanned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.