Abnormal movements
Abnormal movements
At CIC Neurosciences, we conduct three types of studies: therapeutic studies (both industry-sponsored and academic), and pathophysiological studies aimed at unraveling the fundamental mechanisms of diseases in order to advance our understanding and improve patient care.
Industrial therapeutic studies
Academic therapeutic studies
Pathophysiological Studies
BI-ACTIVATE
A randomized, double-blind, placebo-controlled Phase 2 study to evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of orally administered BIA 28-6156 in patients with Parkinson’s disease who carry a pathogenic variant in the glucocerebrosidase (GBA1) gene
🎯: To evaluate the efficacy of BIA 28-6156 in delaying clinically significant motor progression in patients with Parkinson’s disease who carry a pathogenic variant of the GBA1 gene, as assessed by the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (Movement Disorder Society-Unified Parkinson’s Disease Rating Scale or MDS-UPDRS), Part II and Part III.
📝: Currently being monitored
ILY
A multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Radotinib in Parkinson’s disease
🎯: To evaluate the safety and tolerability of radotinib (50, 100, 150, and 200 mg), administered for 6 months, compared with placebo, in patients with Parkinson’s disease.
⏳: Currently being added
ORCHESTRA
An 18-month, double-blind, placebo-controlled, randomized Phase 2a study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of the oral treatment “UCB0599” in patients with early-stage Parkinson’s disease
🎯: To demonstrate the superiority of UCB0599 over placebo in terms of clinical symptoms of Parkinson’s disease progression (at 12 and 18 months) in patients with early-stage Parkinson’s disease.
✅: Done
PADUA
A Phase IIb, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of intravenous prasinezumab in participants with early-stage Parkinson’s disease
🎯: To evaluate the efficacy of prasinezumab compared with placebo, based on the time to significant progression of motor symptoms (an increase of more than 5 points in the Part III score of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) compared with the score at the baseline visit).
📝: Currently being monitored
PASADENA III
A Phase II, double-blind, randomized, placebo-controlled trial evaluating the efficacy of intravenous RO7046015 in patients with early-stage Parkinson’s disease (untreated or treated with a B-MAOI).
🎯: To evaluate the efficacy of RO07046015 on motor and non-motor symptoms of Parkinson’s disease after 12 months compared with placebo.
📝: Currently being monitored
HORIZON
A Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of BIIB101 administered intrathecally in adult patients with multisystem atrophy (MSA)
🎯: To evaluate the tolerability and safety of multiple doses of BIIB101/ION464 administered intrathecally to patients with MSA. In a second phase (extension), evaluate the long-term tolerability and safety of BIIB101/ION464 in participants with MSA, based on the incidence of serious and non-serious adverse events.
📝: Currently being monitored
LUMA
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of BIIB122 in participants with Parkinson’s disease
🎯: To evaluate the efficacy of BIIB122 at 225 mg compared with placebo
📝: Currently being monitored
PROSPER
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of FNP-223 (oral formulation) in slowing the progression of progressive supranuclear palsy (PSP)
🎯: To evaluate the efficacy of FNP-223 in slowing disease progression in participants with PSP, as measured by the PSP Rating Scale (PSPRS), over 52 weeks. To evaluate the safety and tolerability of FNP-223 over 52 weeks in participants with PSP.
⏳: Currently being added
POST STIC
Pre- and post-operative assessment of patients with Tourette syndrome treated with high-frequency bilateral stimulation of the anterior part of the internal globus pallidus
🎯: Describe changes in tic severity (YGTSS-R scores) between M-1 and M60.
⏳: Currently being added
GB MOV
The Role of the Subthalamic Nucleus in Movement Control: The Pathophysiology of Akinetic Symptoms in Parkinson’s Disease
🎯: To understand how the NST is involved in controlling the various stages of movement (from preparation to execution) under both physiological (normal) and pathological (in patients with Parkinson’s disease) conditions, and how these abnormalities are transmitted to target structures (the cortex and midbrain).
📝: Currently being monitored
DATTEP
A non-inferiority study comparing molecular imaging of dopamine transporters using the [123I]-FP-CIT tracer in SPECT and the [18F]LBT-999 biomarker in PET for the differential diagnosis of Parkinson’s disease and essential tremor.
🎯: Visual analysis revealed that [18F]LBT-999 PET imaging performed at least as well as [123I]-FP-CIT SPECT in the differential diagnosis between patients with typical Parkinson’s disease and those with essential tremor.
✅: Done
MAGIC
Effects of directional stimulation of the subthalamic nucleus (STN) on gait and balance in patients with Parkinson’s disease
🎯: To determine the impact of NST-directed deep brain stimulation (DBS) on gait and balance disorders in patients with Parkinson’s disease who have undergone STN DBS, using anatomical and functional data to guide directional programming.
📝: Currently being monitored
NS PARK
Cohort of the French Clinical Research Network on Parkinson's Disease
🎯: Describe the natural history of Parkinson's disease and propose new models of disease progression and response to treatment.
⏳: Currently being added (criteria pending)
PMRE PARKGAME ECO
A health economic evaluation of home-based rehabilitation using serious games for the management of patients with Parkinson’s disease (PD) who have gait and balance disorders.
🎯: To evaluate the 12-month cost-effectiveness of treating patients with Parkinson’s disease (PD) who have gait and balance disorders using therapeutic serious games (SG) compared to standard care alone.
📝: Currently being monitored
At CIC Neurosciences, we conduct three types of studies: therapeutic studies (both industry-sponsored and academic), and pathophysiological studies aimed at unraveling the fundamental mechanisms of diseases in order to advance our understanding and improve patient care.
Industrial therapeutic studies
BI-ACTIVATE
A randomized, double-blind, placebo-controlled Phase 2 study to evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of orally administered BIA 28-6156 in patients with Parkinson’s disease who carry a pathogenic variant in the glucocerebrosidase (GBA1) gene
🎯: To evaluate the efficacy of BIA 28-6156 in delaying clinically significant motor progression in patients with Parkinson’s disease who carry a pathogenic variant of the GBA1 gene, as assessed by the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (Movement Disorder Society-Unified Parkinson’s Disease Rating Scale or MDS-UPDRS), Part II and Part III.
📝: Currently being monitored
ILY
A multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Radotinib in Parkinson’s disease
🎯: To evaluate the safety and tolerability of radotinib (50, 100, 150, and 200 mg), administered for 6 months, compared with placebo, in patients with Parkinson’s disease.
⏳: Currently being added
ORCHESTRA
An 18-month, double-blind, placebo-controlled, randomized Phase 2a study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of the oral treatment “UCB0599” in patients with early-stage Parkinson’s disease
🎯: To demonstrate the superiority of UCB0599 over placebo in terms of clinical symptoms of Parkinson’s disease progression (at 12 and 18 months) in patients with early-stage Parkinson’s disease.
✅: Done
PADUA
A Phase IIb, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of intravenous prasinezumab in participants with early-stage Parkinson’s disease
🎯: To evaluate the efficacy of prasinezumab compared with placebo, based on the time to significant progression of motor symptoms (an increase of more than 5 points in the Part III score of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) compared with the score at the baseline visit).
📝: Currently being monitored
PASADENA III
A Phase II, double-blind, randomized, placebo-controlled trial evaluating the efficacy of intravenous RO7046015 in patients with early-stage Parkinson’s disease (untreated or treated with a B-MAOI).
🎯: To evaluate the efficacy of RO07046015 on motor and non-motor symptoms of Parkinson’s disease after 12 months compared with placebo.
📝: Currently being monitored
HORIZON
A Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of BIIB101 administered intrathecally in adult patients with multisystem atrophy (MSA)
🎯: To evaluate the tolerability and safety of multiple doses of BIIB101/ION464 administered intrathecally to patients with MSA. In a second phase (extension), evaluate the long-term tolerability and safety of BIIB101/ION464 in participants with MSA, based on the incidence of serious and non-serious adverse events.
📝: Currently being monitored
LUMA
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of BIIB122 in participants with Parkinson’s disease
🎯: To evaluate the efficacy of BIIB122 at 225 mg compared with placebo
📝: Currently being monitored
PROSPER
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of FNP-223 (oral formulation) in slowing the progression of progressive supranuclear palsy (PSP)
🎯: To evaluate the efficacy of FNP-223 in slowing disease progression in participants with PSP, as measured by the PSP Rating Scale (PSPRS), over 52 weeks. To evaluate the safety and tolerability of FNP-223 over 52 weeks in participants with PSP.
⏳: Currently being added
Academic therapeutic studies
POST STIC
Pre- and post-operative assessment of patients with Tourette syndrome treated with high-frequency bilateral stimulation of the anterior part of the internal globus pallidus
🎯: Describe changes in tic severity (YGTSS-R scores) between M-1 and M60.
⏳: Currently being added
Pathophysiological Studies
GB MOV
The Role of the Subthalamic Nucleus in Movement Control: The Pathophysiology of Akinetic Symptoms in Parkinson’s Disease
🎯: To understand how the NST is involved in controlling the various stages of movement (from preparation to execution) under both physiological (normal) and pathological (in patients with Parkinson’s disease) conditions, and how these abnormalities are transmitted to target structures (the cortex and midbrain).
📝: Currently being monitored
DATTEP
A non-inferiority study comparing molecular imaging of dopamine transporters using the [123I]-FP-CIT tracer in SPECT and the [18F]LBT-999 biomarker in PET for the differential diagnosis of Parkinson’s disease and essential tremor.
🎯: Visual analysis revealed that [18F]LBT-999 PET imaging performed at least as well as [123I]-FP-CIT SPECT in the differential diagnosis between patients with typical Parkinson’s disease and those with essential tremor.
✅: Done
MAGIC
Effects of directional stimulation of the subthalamic nucleus (STN) on gait and balance in patients with Parkinson’s disease
🎯: To determine the impact of NST-directed deep brain stimulation (DBS) on gait and balance disorders in patients with Parkinson’s disease who have undergone STN DBS, using anatomical and functional data to guide directional programming.
📝: Currently being monitored
NS PARK
Cohort of the French Clinical Research Network on Parkinson's Disease
🎯: Describe the natural history of Parkinson's disease and propose new models of disease progression and response to treatment.
⏳: Currently being added (criteria pending)
PMRE PARKGAME ECO
A health economic evaluation of home-based rehabilitation using serious games for the management of patients with Parkinson’s disease (PD) who have gait and balance disorders.
🎯: To evaluate the 12-month cost-effectiveness of treating patients with Parkinson’s disease (PD) who have gait and balance disorders using therapeutic serious games (SG) compared to standard care alone.
📝: Currently being monitored