Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Canbex Therapeutics

Status and phase: Completed; Phase 2

Conditions: Spasticity in People With Multiple Sclerosis

Treatments: Other: Placebo; Drug: VSN16R

Study type: Interventional

Funder types: Industry

Identifiers

NCT02542787

CBX-001

Details and patient eligibility

About

Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Full description

Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a confirmed diagnosis of MS
• Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening.
• Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 mASH

Exclusion criteria

• Acute MS relapse requiring treatment with steroids within 30 days of screening.
• Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
• Receiving medications that would potentially interfere with the actions of the study medication or outcome variables
• Significant renal and hepatic abnormalities
• Previous history of other significant medical disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days

Treatment:

Drug: VSN16R

Placebo

Placebo Comparator group

Description:

Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days

Treatment:

Other: Placebo