Trial record 1 of 1 for:
biib101
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB101 Administered to Adults With Multiple System Atrophy (HORIZON)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04165486 |
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Recruitment Status :
Active, not recruiting
First Posted : November 18, 2019
Last Update Posted : April 8, 2021
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Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
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Brief Summary:
The primary objective is to evaluate the safety and tolerability of multiple doses of BIIB101 administered via intrathecal (IT) injection to participants with multiple system atrophy (MSA).
The secondary objective is to evaluate the pharmacokinetic (PK) profile of BIIB101.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple System Atrophy | Drug: BIIB101 Drug: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 34 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB101 Administered Intrathecally to Adults With Multiple System Atrophy |
| Actual Study Start Date : | July 7, 2020 |
| Estimated Primary Completion Date : | July 13, 2022 |
| Estimated Study Completion Date : | July 13, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple system atrophy
| Arm | Intervention/treatment |
|---|---|
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Experimental: BIIB101 Low Dose
Participants will be administered BIIB101 low dose and matching placebo via intrathecal (IT) injection at regular intervals.
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Drug: BIIB101
Administered as specified in the treatment arm. Drug: Placebo Administered as specified in the treatment arm. |
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Experimental: BIIB101 Medium Dose
Participants will be administered BIIB101 medium dose and matching placebo via IT injection at regular intervals.
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Drug: BIIB101
Administered as specified in the treatment arm. Drug: Placebo Administered as specified in the treatment arm. |
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Experimental: BIIB101 High Dose
Participants will be administered BIIB101 high dose and matching placebo via IT injection at regular intervals.
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Drug: BIIB101
Administered as specified in the treatment arm. Drug: Placebo Administered as specified in the treatment arm. |
Primary Outcome Measures :
- Number of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Day 253 ]An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Screening up to Day 253 ]An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
Secondary Outcome Measures :
- Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration [ Time Frame: Pre-dose and multiple timepoints up to 24 hours post-dose on Day 1; pre-dose and multiple timepoints up to 6 hours post-dose on 3 subsequent days; post-dose on 6 subsequent days over a 5 ½ month period ]
- Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose and multiple timepoints up to 24 hours post-dose on Day 1; pre-dose and multiple timepoints up to 6 hours post-dose on 3 subsequent days; post-dose on 6 subsequent days over a 5 ½ month period ]
- Time to Reach Maximum Observed Concentration (Tmax) [ Time Frame: Pre-dose and multiple timepoints up to 24 hours post-dose on Day 1; pre-dose and multiple timepoints up to 6 hours post-dose on Days 29, 57 and 85; post-dose on Days 8, 36, 64, 92, 113 and 169 ]
- Serum Concentration of BIIB101 [ Time Frame: Pre-dose and multiple timepoints up to 24 hours post-dose on Day 1; pre-dose and multiple timepoints up to 6 hours post-dose on 3 subsequent days; post-dose on 6 subsequent days over a 5 ½ month period ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Screening single-photon emission computed tomography (SPECT) with DaTscan™ (ioflupane I123 injection) results demonstrating loss (whether symmetric or asymmetric) of dopamine nerve terminals in the striatum consistent with neurodegenerative parkinsonism, as assessed with qualitative, visual read.
- Diagnosed with probable or possible MSA, either parkinsonian-type (MSA-P) or cerebellar-type (MSA-C).
- Must be able to walk unassisted for at least 10 meters (approximately 30 feet)
Key Exclusion Criteria:
- Presence of cognitive dysfunction (defined as Montreal Cognitive Assessment (MoCA) score <25)
- Family history of ataxia or parkinsonism and known genetic cause of ataxia or parkinsonism.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165486
Locations
| Austria | |
| Medizinische Universität Innsbruck | |
| Innsbruck, Austria, 6020 | |
| France | |
| Hopital Purpan | |
| Toulouse Cedex 09, Haute Garonne, France, 31059 | |
| Hopital Roger Salengro - CHU Lille | |
| Lille Cedex, Nord, France, 59037 | |
| Groupe Hospitalier Pitie-Salpetriere | |
| Paris, France, 75013 | |
| Germany | |
| Universitaetsklinikum Ulm | |
| Ulm, Baden Wuerttemberg, Germany, 89081 | |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg | |
| Marburg, Hessen, Germany, 35043 | |
| Medizinische Hochschule Hannover | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Universitaetsklinikum Duesseldorf AoeR | |
| Duesseldorf, Nordrhein Westfalen, Germany, 40225 | |
Sponsors and Collaborators
Biogen
Investigators
| Study Director: | Medical Director | Biogen |
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT04165486 |
| Other Study ID Numbers: |
262SP101 2019-001105-24 ( EudraCT Number ) |
| First Posted: | November 18, 2019 Key Record Dates |
| Last Update Posted: | April 8, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/ |
| URL: | https://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Multiple System Atrophy Shy-Drager Syndrome Atrophy Pathological Conditions, Anatomical Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases |