All > Minnesota > Spokane

BIA 28-6156 10 mg for Parkinson's Disease

Renstar Medical Research, Ocala, FL
Parkinson's DiseaseBIA 28-6156 10 mg - Drug
Eligibility
35 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a drug to slow motor decline in Parkinson's patients with a certain gene mutation.

Eligible Conditions
  • Parkinson's Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
1
AAV2-GDNF
1
Altropane (123I) Injection

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: From Baseline up to Week 78

Week 78
Change from Baseline to Week 78 in the 39-Item Parkinson's Disease Questionnaire (PDQ-39) score
Change from Baseline to Week 78 in the MDS-UPDRS Total (Part I-IV) score
Change from Baseline to Week 78 in the Modified Hoehn and Yahr score
Time from baseline to any worsening on the Clinical Global Impression - Change (CGI-C) scale
Time from baseline to any worsening on the Patient Global Impression - Change (PGI-C) scale
Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living (assessed by MDS-UPDRS Part II score and MDS-UPDRS Part III score)
Time from baseline to clinically meaningful progression on motor signs of the disease (assessed by MDS-UPDRS Part III score)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
1
AAV2-GDNF
2
Altropane (123I) Injection

Trial Design

3 Treatment Groups

BIA 28-6156 10 mg
1 of 3
BIA 28-6156 60 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

237 Total Participants · 3 Treatment Groups

Primary Treatment: BIA 28-6156 10 mg · Has Placebo Group · Phase 2

BIA 28-6156 10 mg
Drug
Experimental Group · 1 Intervention: BIA 28-6156 10 mg · Intervention Types: Drug
BIA 28-6156 60 mg
Drug
Experimental Group · 1 Intervention: BIA 28-6156 60 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to week 78

Who is running the clinical trial?

Bial R&D Investments, S.A.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Luís M Magalhães, PharmDStudy DirectorBial R&D Investments, S.A.

Eligibility Criteria

Age 35 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The individual has achieved a score of 22 or higher on the Montreal Cognitive Assessment (MoCA).
Your Hoehn and Yahr score is less than or equal to 2.5, indicating a mild stage of Parkinson's disease.
The subject is receiving therapeutic aid for PD-related symptoms.
The subject does not have significant motor instability or debilitating involuntary movements, as determined by the researcher.
References

Frequently Asked Questions

Is the upper age limit for participants in this trial greater than seventy-five?

"As per the trial's eligibility requirements, individuals aged 35 to 80 may take part in this study." - Anonymous Online Contributor

Unverified Answer

Are there numerous facilities in Canada involved with this research endeavor?

"This clinical trial is running in 73 locations across the nation, such as Aurora, Boca Raton and Ocala. It may be beneficial to choose a site close by so you can minimize travel if accepted into the study." - Anonymous Online Contributor

Unverified Answer

For whom is this medical study available?

"To meet the requirements of this clinical trial, participants should have been diagnosed with Parkinson's Disease and be between 35-80 years old. This experiment is seeking 237 individuals in total." - Anonymous Online Contributor

Unverified Answer

How many volunteers are contributing to this clinical research?

"In order to begin this trial, 237 individuals who fulfil the qualifications must be enrolled. These potential participants can travel to either University of Colorado in Aurora, CO or Parkinson's Disease and Movement Disorders Center of Boca Raton in Boca Raton, FL." - Anonymous Online Contributor

Unverified Answer

What potential hazards are associated with the ingestion of BIA 28-6156 10 mg?

"Having assessed the data available, our team at Power rated BIA 28-6156 10 mg with a 2: there is some research indicating its safety but no evidence of efficacy." - Anonymous Online Contributor

Unverified Answer

Is it still possible for patients to join this clinical investigation?

"According to the clinicaltrials.gov listings, this trial was first made available on March 31st 2021; it has remained open for recruitment with a recent update being posted on April 18th of 2021." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top