CompletedPhase 3

Dysport® Adult Lower Limb Spasticity Follow-on Study

United States, Australia, Belgium352 participantsStarted 2011-06

Plain-language summary

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404) Exclusion Criteria: * Fixed contractures in lower limb

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to EOS (maximum duration of 52 weeks).

Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Heart Rate (HR)

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Haematocrit

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)

Trial details

NCT IDNCT01251367

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2017-07-03

View on ClinicalTrials.gov More Post-stroke Spasticity trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404) Exclusion Criteria: * Fixed contractures in lower limb

What they're measuring

Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to EOS (maximum duration of 52 weeks).

Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Heart Rate (HR)

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Haematocrit

Timeframe: Baseline and Week 4 of each cycle

Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)