BIIB122 for Early-Stage Parkinson's Disease

(LUMA Trial)

Recruiting at 127 trial locations

Overseen By Anthony Emanuele

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biogen

Disqualifiers: Stroke, Dementia, Seizure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

Duration: 48 to 144 weeks

650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called BIIB122 to see if it can slow down symptoms in people with early-stage Parkinson's disease. The drug works by blocking a protein that may cause the disease to get worse. Participants will take the drug for several years to see if it helps.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug BIIB122 different from other Parkinson's disease treatments?

BIIB122 (DNL151) is unique because it targets specific biological pathways that may offer neuroprotection and potentially modify the progression of Parkinson's disease, addressing an urgent need for treatments that go beyond just alleviating symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

This trial is for people aged 30-80 with early-stage Parkinson's disease, diagnosed within the last two years. Participants should have mild symptoms (stages 1 to 2 on a specific scale) and score ≤40 on a PD symptom questionnaire. They can't join if they have other significant neurological issues, atypical parkinsonism, drug-induced parkinsonism, or cognitive impairment as indicated by a MoCA score <24.

Inclusion Criteria

My Parkinson's is in the early to mid stages.

I was diagnosed with Parkinson's disease within the last 2 years and was over 30 at diagnosis.

MDS-UPDRS Parts II and III (in OFF state) combined score ≤40 at screening

Exclusion Criteria

I haven't had a major neurological issue like stroke or dementia in the last 5 years.

I have a rare form of Parkinson's or my Parkinson's may be caused by medication.

My memory and thinking test score was below 24.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BIIB122 or placebo tablets by mouth once daily

48 to 144 weeks

Up to 29 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIIB122

Trial Overview The study tests BIIB122 tablets against placebo to see if it slows down symptom worsening in early Parkinson's over a period of up to three years. Patients will take either the drug or placebo daily and attend clinic visits every three months. The effectiveness will be measured using the MDS-UPDRS questionnaire assessing PD symptoms' impact on daily life.

How Is the Trial Designed?

Group I: BIIB122 225 mg Experimental Treatment 1 Intervention

Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.

Group II: BIIB122 Matching Placebo Placebo Group 1 Intervention

Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Denali Therapeutics Inc.

Industry Sponsor

Trials

24

Recruited

1,900+

Published Research Related to This Trial

Current dopamine replacement therapies can alleviate motor symptoms of Parkinson's disease, but there is a significant need for improved treatments that also address non-motor symptoms and provide neuroprotection.

Research is focusing on identifying promising biological targets and therapeutic agents, with an emphasis on understanding genetic factors and enhancing the translation of findings from animal models to human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priorities in Parkinson's disease research. Meissner, WG., Frasier, M., Gasser, T., et al.[2022]

A new drug has demonstrated potential in delaying the onset of Parkinsonism, which is a significant advancement for patients at risk of developing this condition.

The findings suggest that this drug could improve the quality of life for individuals by postponing the debilitating symptoms associated with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delaying the onset of parkinson's disease. [2016]

COMT inhibitors have been shown to effectively prolong the action of levodopa in Parkinson's disease patients experiencing the 'wearing off' phenomenon, providing a new treatment option for those with fluctuating responses to standard therapy.

Clozapine not only alleviates levodopa-induced psychosis but also helps reduce tremors and dyskinesias, highlighting its dual role in managing symptoms of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New medical and surgical treatments for Parkinson's disease. Klockgether, T., Löschmann, PA., Wüllner, U.[2019]

In a study involving eight parkinsonian monkeys, co-administration of the NMDA receptor antagonist CI-1041 with L-dopa significantly reduced the development of L-dopa-induced dyskinesias (LID), with only one monkey showing mild symptoms compared to all four in the L-dopa alone group.

The effectiveness of L-dopa in alleviating Parkinson's symptoms remained similar in both treatment groups, indicating that CI-1041 can potentially manage LID without compromising the therapeutic benefits of L-dopa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a selective glutamate antagonist on L-dopa-induced dyskinesias in drug-naive parkinsonian monkeys. Hadj Tahar, A., Grégoire, L., Darré, A., et al.[2014]

A variety of new pharmacological treatments for Parkinson's disease (PD) are being developed, including modified forms of L-dopa and enzyme inhibitors, which target different aspects of the disease.

In addition to dopaminergic treatments, non-dopaminergic options and neuroprotective agents are emerging, aiming to improve symptoms and potentially halt disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs in development for Parkinson's disease. Johnston, TH., Brotchie, JM.[2007]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Priorities in Parkinson's disease research. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Delaying the onset of parkinson's disease. [2016]

3. England pubmed.ncbi.nlm.nih.gov

New medical and surgical treatments for Parkinson's disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a selective glutamate antagonist on L-dopa-induced dyskinesias in drug-naive parkinsonian monkeys. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Drugs in development for Parkinson's disease. [2007]