Clinical Trials


 


      E2027

 

Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Participants With Dementia With Lewy Bodies.
PI: Angelo Antonini
Brief summary: This study will be conducted to compare E2027 to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.
Number of study locations: 80.
clinicaltrial.gov link: click here.


      M15-741


Recruiting not yet started

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease.
PI: Angelo Antonini
Brief summary: The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with Parkinson's disease.
Number of study locations: 7.
clinicaltrial.gov link: click here.


      Z7219K01


Recruiting not yet started

A 12-weeks, multicentre, randomized, double-blinded, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of Safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy.
PI: Angelo Antonini
Brief summary: The study is a randomized placebo controlled double blinded study, with two parallel arms, in which participants will be assigned in a 2:1 ratioto receive either safinamide or placebo. Study population is patients diagnosed, less than two years ago, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa. Outcome will be assessed after 12 weeks of treatment, when progression is unlikely to be a confounder of change.
clinicaltrial.gov link: not available.


      IPX203-B16-02


Recruiting not yet started

A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-releease cardbidopa-levodopa in Parkinson's Disease patients with motor fluctuations.
PI: Angelo Antonini
Primary objective: to evaluate the safety and efficacy of IPX203 in comparison to IR CD-LD in the treatment of CD-LD experienced subjects with Parkinson's Disease (PD) who have motor fluctuations.
clinicaltrial.gov link: not available.


      ND0612-317


Recruiting not yet started

A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless).
PI: Angelo Antonini
Primary objective: to determine the effect of ND0612 on daily “ON” time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and “ON” time with non-troublesome dyskinesia) using subject-completed “ON/OFF” diary assessments of motor function in subjects with Parkinson’s disease (PD) experiencing motor fluctuations.
clinicaltrial.gov link: https://clinicaltrials.gov/ct2/show/NCT04006210


      CVL-751-PD


Recruiting not yet started

CVL-751-PD-001 A phase 3, double-blinded, randomized, placebo-controlled, parallel-group, 27-week trial of the efficacy, safety, and tolerability of two fixed doses of Tavapadon in early Parkinson's Disease.
CVL-751-PD-003 A phase 3, double-blinded, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial of the efficacy, safety, and tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated adults with motor fluctuations.
CVL-751-PD-004 58-week open-label trial of Tavapadon in Parkinson's Disease.

PI: Angelo Antonini
Primary objective:
CVL-751-PD-001 to assess the efficacy of 2 fixed doses of Tavapadon in subjects with early PD;
CVL-751-PD-003 to assess the effect of Tavapadon on the change from baseline in total daily hours of “on” time without troublesome dyskinesia in levodopa (L-Dopa)-treated subjects with PD who are experiencing motor fluctuations;
CVL-751-PD-004 to evaluate the safety and tolerability of long-term administration of Tavapadon in subjects with PD; to evaluate the effects of Tavapadon on PD symptoms during long-term treatment; and to evaluate speech and facial expression characteristics of subjects with PD.
clinicaltrial.gov link: not available.


      UCB


Recruiting not yet started

A double-blinded, placebo-controlled, phase 2 study to evaluate efficacy, safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).
PI: Angelo Antonini
Primary objective: to evaluate the efficacy of UCB0107 in slowing disease progression in subjects with PSP measured by the PSP Rating Scale (PSPRS) total score.
clinicaltrial.gov link: not available.


      BHV3241-301


Recruiting not yet started

Randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of BHV-3241 in subjects with Multiple System Atrophy (M-STAR Study).
PI: Angelo Antonini
Primary objective: to evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in the Unified MSA Rating Scale (UMSARS) Part I and II total score at week 48, and to assess the safety and tolerability of BHV-3241, relative to placebo, in subjects with MSA.
clinicaltrial.gov link: click here.


      CTH


Recruiting not yet started

CTH-301 An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (“OFF” Episodes)
CTH-302 An open-label, randomized, crossover trial utilizing a single-blinded rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa responsive subjects with Parkinson's Disease complicated by motor fluctuations.

PI: Angelo Antonini
clinicaltrial.gov link: not available.


      PD-PAMELA


Recruiting not yet started

Parkinson's Disease fluctuations treatment PAthway: MulticEnter itaLian observationAl study, PD-PAMELA.
PI: Angelo Antonini
Primary objecetive: description of the therapeutic pathway of fluctuations in PD patients with 10-15 years PD diagnosis, in Italian real practice.
clinicaltrial.gov link: not available.

Closed


      ACP-103-045

 



A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
PI: Angelo Antonini
Brief summary: The purpose of this study is to evaluate the efficacy of pimavanserin by comparing pimavanserin with placebo in preventing a relapse of psychotic symptoms in subjects with dementia-related psychosis and who were stabilized after 12 weeks of open label pimavanserin treatment.
Number of study locations: 117.
clinicaltrial.gov link: click here.