Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression (ONTIME Pilot)

Ipsen

Status and phase: Completed; Phase 4

Conditions: Upper Limb Spasticity; Stroke

Treatments: Drug: Placebo; Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02321436

Y-79-52120-197

Details and patient eligibility

About

The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 2 to 12 weeks after first ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as previous stroke)

• Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke

• Presence of spasticity:

  • either symptomatic, based on symptomatic spasticity criteria (i.e. at least one of the following items: impacted passive/active function, involuntary movements, or pain ≥4 on a numeric pain rating scale [NPRS]), in addition to increased muscle tone [Modified Ashworth Scale, MAS ≥2])
  • or only increased muscle tone (MAS≥2)

Exclusion criteria

• Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including prior local joint, tendon, and intrinsic muscle disorders) that could potentially interfere with assessment of spasticity in the primary targeted muscle group selected by the Investigator and in agreement with the subject
• Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides, aminoquinolines, cyclosporine, D penicillamine
• Previous surgery of the affected muscles/ ligaments/tendons
• Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple organ failure, hepatic renal failures, severe infections)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

Dysport® 500U intramuscular injection

Treatment:

Biological: Botulinum toxin type A

Placebo Group

Placebo Comparator group

Description:

Placebo intramuscular injection

Treatment:

Drug: Placebo