The purpose of the study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Percentage of participants with treatment emergent adverse events (TEAEs).
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: From baseline until the end of study (9 months)
Percentage of participants with adverse events of special interest (AESI).
Time frame: From baseline until the end of study (9 months)
Change from baseline in vital sign parameter (blood pressure)
Time frame: 9 months
Change from baseline in vital sign parameter (Heart rate)
Time frame: 9 months
Change from baseline in clinical laboratory test results.
Number and percentage of participants with low, normal or high values and normal or abnormal examinations will be presented.
Time frame: 9 months
Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)
Time frame: From baseline until the end of study (9 months)
Change from baseline in physical examination findings.
Number of Participants with change in physical examination findings
Time frame: 9 months
Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)
MAS is a scale to assess muscle tone in the injected muscles. The muscle tone will be rated as per grading from 0 to 4, there 0 =No increase in muscle tone and 4 =Affected part(s) rigid in flexion or extension.
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Rancho Los Amigos National Rehab
Downey, California, United States
RECRUITINGKansas Institute of Research
Overland Park, Kansas, United States
RECRUITINGQuest Research Institute
Farmington Hills, Michigan, United States
TERMINATEDEinstein Physical Medicine and Rehabilitation at Elkins Park
Elkins Park, Pennsylvania, United States
RECRUITINGThe University of Texas Southwestern Medical Center
Dallas, Texas, United States
NOT_YET_RECRUITINGKepler University Hospital GmbH, Department of Neurology and Psychiatry
Linz, Austria
RECRUITINGBrothers of Charity Hospital Linz, Department of Neurology I
Linz, Austria
RECRUITINGMedical University Vienna, Department of Neurology
Vienna, Austria
WITHDRAWNMultiprofile Hospital for Active Treatment "Heart and Brain"
Pleven, Bulgaria
WITHDRAWNMedical Center "Rusemed" EOOD
Rousse, Bulgaria
RECRUITING...and 51 more locations
Time frame: from baseline until the end of study (9 months)
Change from Baseline to post-treatment Day 29 in MAS score in the PTMG.
If PD profile of IPN10200 in dose escalation indicates a peak of effect different than Day 29, the endpoint will be modified accordingly)
Time frame: From baseline until post-treatment Day 29
Change from Baseline in MAS score in all injected muscle Groups
Time frame: From baseline until the end of study (9 months)
Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score).
Time frame: From baseline until the end of study (9 months)
Peak of effect - maximal decrease in the MAS score from Baseline.
Time frame: From baseline until the end of study (9 months)
Time to peak - time to reach the peak of effect (maximal decrease in the MAS score from Baseline).
Time frame: From baseline until the end of study (9 months)
Duration of effect - duration between time to onset and last timepoint with a response to Treatment.
Time frame: From baseline until the end of study (9 months)
Response to treatment as measured by at least one grade reduction in MAS score in the PTMG from Baseline
Time frame: From baseline until the end of study (9 months)
Response to treatment as measured by at least one grade reduction in MAS score in all injected muscles from Baseline
Time frame: From baseline until the end of study (9 months)
Physician's Global Assessment (PGA) score of overall treatment response
The PGA is a 9-point scale (from -4= markedly worse to +4=markedly improved) used to assess global overall treatment response by the investigator.
Time frame: From baseline until the end of study (9 months)
Patient Global Impression of Change in the Spastic Clinical Pattern using specific scale (PGI-c)
PGI-C is a scale to assess global impression of change in the spastic clinical pattern using a 7-point Likert scale (from -3: very much worse to +3: very much improved) by answering a specific question
Time frame: from baseline until the end of study (9 months)
Change from Baseline in the Disability Assessment Scale (DAS)
The DAS will be used to assess the effect of upper limb spasticity on hygiene, dressing, limb position and pain. Participants will be assessed in an interview format.
Time frame: From baseline until the end of study (9 months)
Reduction of pain in the shoulder (adducted/rotated pattern) using the Numeric Rating Scale
Time frame: From baseline until the end of study (9 months)
The number and percentage of participants with presence of IPN10200 and BoNT-A antibodies and titres (binding and neutralising)
Time frame: At baseline