Parkinson's Disease
Conditions
Keywords
BIIB054, Alpha-synuclein
Brief summary
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.
Interventions
DRUGPlacebo
Administered as specified in the treatment arm
DRUGBIIB054
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening. * Score of ≤2.5 on the Modified Hoehn and Yahr Scale. * Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis. * Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading). * All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.
Exclusion criteria
* Presence of freezing of gait. * Montreal cognitive assessment (MOCA) score \<23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation. * History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader. * History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study. * Participation in any active immunotherapy study targeting alpha-synuclein. * Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study. * Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator. * Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study). NOTE : Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 | Baseline, Week 52 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72 | Baseline, Week 72 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 3 years | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator 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; is a medically important event. |
| Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96 | Baseline, Week 96 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Serum Concentration of BIIB054 | Pre-dose and 1 hour post-dose of Baseline, Weeks 4, 8, 12, 16, 24, 32, 36, 44, 52, 60, 68, 84, 96, 120 and 144 | — |
| Change From Baseline in MDS-UPDRS Subpart I Score at Week 52 | Baseline, Week 52 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Baseline, Weeks 72 and 96 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Change From Baseline in MDS-UPDRS Subpart III Score at Week 52 | Baseline, Week 52 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Baseline, Weeks 72 and 96 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52 | Baseline, Week 52 | SBR in the putamen as measured by SPECT imaging of the dopamine transporter (DaT) with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values. |
| Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52 | Baseline, Week 52 | SBR in the striatum as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values. |
| Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52 | Baseline, Week 52 | SBR in the caudate as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values. |
| Percentage of Participants With Anti-BIIB054 Antibodies in the Serum | Up to Week 144 | — |
| Change From Baseline in MDS-UPDRS Subpart II Score at Week 52 | Baseline, Week 52 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
| Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Baseline, Weeks 72 and 96 | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values. |
Countries
Austria, Canada, France, Germany, Israel, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 75 investigational sites from 10 January 2018 to 29 April 2021.
Pre-assignment details
Participants with Parkinson's Disease (PD) were enrolled and randomized to receive placebo or BIIB054 250/1250/3500 milligrams (mg) for Year 1 in Placebo-Controlled (PC) Period. Following Year 1, participants on placebo (delayed start) were re-randomized to receive BIIB054 250/1250/3500 mg dose, and others on BIIB054 in Year 1 continued to receive the same dose until their Week 96 visit.
Participants by arm
| Arm | Count |
|---|---|
| PC Period: Placebo Participants received BIIB054-matching placebo, intravenous (IV) infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period. | 100 |
| PC Period: BIIB054 250 mg (Early Start) Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period. | 55 |
| PC Period: BIIB054 1250 mg (Early Start) Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period. | 102 |
| PC Period: BIIB054 3500 mg (Early Start) Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period. | 100 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| DBE Period:Year 2 to EOS (Up to 3 Years) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 2 |
| DBE Period:Year 2 to EOS (Up to 3 Years) | Consent Withdrawn | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 2 |
| DBE Period:Year 2 to EOS (Up to 3 Years) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| DBE Period:Year 2 to EOS (Up to 3 Years) | Investigator Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| DBE Period:Year 2 to EOS (Up to 3 Years) | Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 3 | 0 |
| DBE Period:Year 2 to EOS (Up to 3 Years) | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 17 | 36 | 39 | 48 | 94 | 91 |
| PC Period: Up to Year 1 | Adverse Event | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Up to Year 1 | Consent Withdrawn | 3 | 2 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | PC Period: BIIB054 250 mg (Early Start) | PC Period: BIIB054 1250 mg (Early Start) | PC Period: BIIB054 3500 mg (Early Start) | PC Period: Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 9.01 | 61.3 years STANDARD_DEVIATION 9.24 | 59.2 years STANDARD_DEVIATION 8.48 | 59.3 years STANDARD_DEVIATION 9.92 | 61.0 years STANDARD_DEVIATION 8.39 |
| Baseline MDS-UPDRS Subpart III Score | 22.8 score on a scale STANDARD_DEVIATION 8.99 | 23.5 score on a scale STANDARD_DEVIATION 9.38 | 22.8 score on a scale STANDARD_DEVIATION 8.69 | 22.9 score on a scale STANDARD_DEVIATION 8.86 | 22.2 score on a scale STANDARD_DEVIATION 9.31 |
| Baseline MDS-UPDRS Subpart II Score | 5.3 score on a scale STANDARD_DEVIATION 3.84 | 5.0 score on a scale STANDARD_DEVIATION 3.3 | 5.3 score on a scale STANDARD_DEVIATION 3.66 | 5.5 score on a scale STANDARD_DEVIATION 4.3 | 5.4 score on a scale STANDARD_DEVIATION 3.87 |
| Baseline MDS-UPDRS Subpart I Score | 4.3 score on a scale STANDARD_DEVIATION 3.59 | 3.3 score on a scale STANDARD_DEVIATION 2.74 | 4.8 score on a scale STANDARD_DEVIATION 3.99 | 4.3 score on a scale STANDARD_DEVIATION 3.6 | 4.3 score on a scale STANDARD_DEVIATION 3.5 |
| Baseline Movement Disorder Society Sponsored Revision of the Unified PD Rating Scale Total Score | 32.4 score on a scale STANDARD_DEVIATION 12.69 | 31.9 score on a scale STANDARD_DEVIATION 12.25 | 32.9 score on a scale STANDARD_DEVIATION 12.58 | 32.6 score on a scale STANDARD_DEVIATION 13.46 | 31.9 score on a scale STANDARD_DEVIATION 12.41 |
| Baseline Total Caudate SBR | 1.391 striatal binding ratio STANDARD_DEVIATION 0.3501 | 1.433 striatal binding ratio STANDARD_DEVIATION 0.3751 | 1.397 striatal binding ratio STANDARD_DEVIATION 0.3417 | 1.416 striatal binding ratio STANDARD_DEVIATION 0.3643 | 1.336 striatal binding ratio STANDARD_DEVIATION 0.3279 |
| Baseline Total Putamen SBR | 1.295 striatal binding ratio STANDARD_DEVIATION 0.3597 | 1.388 striatal binding ratio STANDARD_DEVIATION 0.4294 | 1.291 striatal binding ratio STANDARD_DEVIATION 0.3269 | 1.286 striatal binding ratio STANDARD_DEVIATION 0.3627 | 1.255 striatal binding ratio STANDARD_DEVIATION 0.3429 |
| Baseline Total Striatum Striatal Binding Ratio (SBR) | 1.342 striatal binding ratio STANDARD_DEVIATION 0.3393 | 1.409 striatal binding ratio STANDARD_DEVIATION 0.3875 | 1.342 striatal binding ratio STANDARD_DEVIATION 0.3197 | 1.351 striatal binding ratio STANDARD_DEVIATION 0.3495 | 1.295 striatal binding ratio STANDARD_DEVIATION 0.3177 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 1 Participants | 1 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 345 Participants | 54 Participants | 101 Participants | 94 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 2 Participants | 6 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) White | 325 Participants | 53 Participants | 92 Participants | 84 Participants | 96 Participants |
| Sex: Female, Male Female | 107 Participants | 16 Participants | 29 Participants | 34 Participants | 28 Participants |
| Sex: Female, Male Male | 250 Participants | 39 Participants | 73 Participants | 66 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 55 | 0 / 102 | 0 / 100 | 0 / 20 | 0 / 37 | 0 / 39 | 0 / 52 | 0 / 100 | 1 / 94 |
| other Total, other adverse events | 58 / 100 | 32 / 55 | 61 / 102 | 63 / 100 | 16 / 20 | 22 / 37 | 22 / 39 | 25 / 52 | 51 / 100 | 56 / 94 |
| serious Total, serious adverse events | 7 / 100 | 4 / 55 | 4 / 102 | 6 / 100 | 2 / 20 | 3 / 37 | 3 / 39 | 3 / 52 | 5 / 100 | 7 / 94 |
Outcome results
Primary
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 | 10.78 score on a scale | Standard Error 1.49 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 | 10.48 score on a scale | Standard Error 1.951 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 | 11.29 score on a scale | Standard Error 1.446 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 | 10.86 score on a scale | Standard Error 1.518 |
Comparison: Change From Baseline in MDS-UPDRS Total Score at Week 52p-value: 0.897695% CI: [-4.888, 4.287]Mixed Model for Repeated Measures
Comparison: Change From Baseline in MDS-UPDRS Total Score at Week 52p-value: 0.79695% CI: [-3.31, 4.312]Mixed Model for Repeated Measures
Comparison: Change From Baseline in MDS-UPDRS Total Score at Week 52p-value: 0.969595% CI: [-3.805, 3.956]Mixed Model for Repeated Measures
Primary
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 72
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure. Number of participants analyzed were participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72 | 7.11 score on a scale | Standard Error 1.476 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72 | 6.83 score on a scale | Standard Error 2.032 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72 | 8.66 score on a scale | Standard Error 1.496 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72 | 6.94 score on a scale | Standard Error 1.508 |
Comparison: Change From Baseline in MDS-UPDRS Total Score at Week 72p-value: 0.909395% CI: [-5.035, 4.483]Mixed Model for Repeated Measures
Comparison: Change From Baseline in MDS-UPDRS Total Score at Week 72p-value: 0.432795% CI: [-2.336, 5.44]Mixed Model for Repeated Measures
Comparison: Change From Baseline in MDS-UPDRS Total Score at Week 72p-value: 0.93395% CI: [-4.051, 3.719]Mixed Model with repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Subpart III Score at Week 52
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart III Score at Week 52 | 6.10 score on a scale | Standard Error 1.083 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Week 52 | 6.69 score on a scale | Standard Error 1.419 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Week 52 | 6.76 score on a scale | Standard Error 1.046 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Week 52 | 6.20 score on a scale | Standard Error 1.104 |
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 52p-value: 0.727495% CI: [-2.742, 3.925]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 52p-value: 0.638595% CI: [-2.094, 3.411]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 52p-value: 0.946795% CI: [-2.718, 2.91]Mixed Model for Repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Weeks 72 and 96
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from (Placebo/BIIB054 250/1250/3500 mg) for the analysis of this outcome measure. Number analyzed is the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 72 | 3.64 score on a scale | Standard Error 1.027 |
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 96 | 4.49 score on a scale | Standard Error 1.174 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 96 | 5.14 score on a scale | Standard Error 1.679 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 72 | 4.48 score on a scale | Standard Error 1.404 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 72 | 4.49 score on a scale | Standard Error 1.038 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 96 | 4.39 score on a scale | Standard Error 1.18 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 72 | 3.69 score on a scale | Standard Error 1.048 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96 | Change from Baseline at Week 96 | 5.17 score on a scale | Standard Error 1.201 |
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 72p-value: 0.611295% CI: [-2.423, 4.114]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 72p-value: 0.52795% CI: [-1.806, 3.52]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 72p-value: 0.967395% CI: [-2.608, 2.719]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 96p-value: 0.745595% CI: [-3.274, 4.569]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 96p-value: 0.950695% CI: [-3.192, 2.997]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart III Score at Week 96p-value: 0.664395% CI: [-2.422, 3.794]Mixed Model for Repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Subpart II Score at Week 52
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart II Score at Week 52 | 3.17 score on a scale | Standard Error 0.473 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Week 52 | 2.72 score on a scale | Standard Error 0.621 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Week 52 | 3.16 score on a scale | Standard Error 0.46 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Week 52 | 3.01 score on a scale | Standard Error 0.486 |
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 52p-value: 0.549795% CI: [-1.889, 1.007]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 52p-value: 0.99895% CI: [-1.2, 1.197]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 52p-value: 0.806995% CI: [-1.374, 1.07]Mixed Model for Repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Weeks 72 and 96
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from (Placebo/BIIB054 250/1250/3500 mg) for the analysis of this outcome measure. Number analyzed is the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 1.83 score on a scale | Standard Error 0.491 |
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 1.87 score on a scale | Standard Error 0.529 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 1.33 score on a scale | Standard Error 0.762 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 1.62 score on a scale | Standard Error 0.672 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 2.36 score on a scale | Standard Error 0.497 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 2.39 score on a scale | Standard Error 0.533 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 1.68 score on a scale | Standard Error 0.503 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 2.22 score on a scale | Standard Error 0.541 |
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 72p-value: 0.796895% CI: [-1.786, 1.372]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 72p-value: 0.421195% CI: [-0.766, 1.827]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 72p-value: 0.816695% CI: [-1.448, 1.143]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 96p-value: 0.553595% CI: [-2.31, 1.24]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 96p-value: 0.465495% CI: [-0.881, 1.922]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart II Score at Week 96p-value: 0.618495% CI: [-1.051, 1.763]Mixed Model for Repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Subpart I Score at Week 52
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). Number of participants analyzed were participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart I Score at Week 52 | 1.43 score on a scale | Standard Error 0.436 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Week 52 | 0.90 score on a scale | Standard Error 0.57 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Week 52 | 1.56 score on a scale | Standard Error 0.423 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Week 52 | 1.65 score on a scale | Standard Error 0.446 |
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 52p-value: 0.432795% CI: [-1.851, 0.794]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 52p-value: 0.815595% CI: [-0.965, 1.225]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 52p-value: 0.701595% CI: [-0.899, 1.334]Mixed Model for Repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Weeks 72 and 96
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure. Number analyzed is the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 1.65 score on a scale | Standard Error 0.395 |
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 1.95 score on a scale | Standard Error 0.398 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 1.69 score on a scale | Standard Error 0.568 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 0.61 score on a scale | Standard Error 0.538 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 1.73 score on a scale | Standard Error 0.402 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 1.93 score on a scale | Standard Error 0.403 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 72 | 1.63 score on a scale | Standard Error 0.405 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96 | Change from Baseline at Week 96 | 1.72 score on a scale | Standard Error 0.414 |
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 72p-value: 0.103895% CI: [-2.276, 0.213]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 72p-value: 0.868995% CI: [-0.933, 1.103]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 72p-value: 0.98295% CI: [-1.026, 1.003]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 96p-value: 0.69395% CI: [-1.563, 1.04]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 96p-value: 0.960695% CI: [-1.053, 1.001]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MDS-UPDRS Subpart I Score at Week 96p-value: 0.651295% CI: [-1.269, 0.794]Mixed Model for Repeated Measures
Secondary
Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 96
Population: The ITT population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo). As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure. Number of participants analyzed were participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96 | 7.88 score on a scale | Standard Error 1.616 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96 | 8.28 score on a scale | Standard Error 2.317 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96 | 8.71 score on a scale | Standard Error 1.628 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96 | 8.87 score on a scale | Standard Error 1.659 |
p-value: 0.882895% CI: [-5.013, 5.825]Mixed Model for Repeated Measures
p-value: 0.701995% CI: [-3.458, 5.128]Mixed Model for Repeated Measure
p-value: 0.651995% CI: [-3.323, 5.301]Mixed Model for Repeated Measures
Secondary
Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52
SBR in the caudate as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The pharmacodynamic population was defined as a subset of the ITT population with at least 1 post-baseline pharmacodynamic measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52 | -0.067 striatal binding ratio | Standard Error 0.0166 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52 | -0.075 striatal binding ratio | Standard Error 0.0219 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52 | -0.060 striatal binding ratio | Standard Error 0.0161 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52 | -0.089 striatal binding ratio | Standard Error 0.0171 |
p-value: 0.758595% CI: [-0.0625, 0.0456]Mixed Model for Repeated Measures
p-value: 0.780895% CI: [-0.0391, 0.052]Mixed Model for Repeated Measures
p-value: 0.353295% CI: [-0.0691, 0.0248]Mixed Model for Repeated Measures
Secondary
Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52
SBR in the striatum as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The pharmacodynamic population was defined as a subset of the ITT population with at least 1 post-baseline pharmacodynamic measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52 | -0.081 striatal binding ratio | Standard Error 0.0145 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52 | -0.090 striatal binding ratio | Standard Error 0.0191 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52 | -0.081 striatal binding ratio | Standard Error 0.014 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52 | -0.108 striatal binding ratio | Standard Error 0.0148 |
p-value: 0.707995% CI: [-0.0562, 0.0382]Mixed Model for Repeated Measures
p-value: 0.983595% CI: [-0.04, 0.0392]Mixed Model for Repeated Measures
p-value: 0.186995% CI: [-0.0682, 0.0134]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52
SBR in the putamen as measured by SPECT imaging of the dopamine transporter (DaT) with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.
Time frame: Baseline, Week 52
Population: The pharmacodynamic population was defined as a subset of the ITT population with at least 1 post-baseline pharmacodynamic measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC Period: Placebo | Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52 | -0.093 striatal binding ratio | Standard Error 0.0151 |
| PC Period: BIIB054 250 mg (Early Start) | Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52 | -0.098 striatal binding ratio | Standard Error 0.0199 |
| PC Period: BIIB054 1250 mg (Early Start) | Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52 | -0.102 striatal binding ratio | Standard Error 0.0146 |
| PC Period: BIIB054 3500 mg (Early Start) | Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52 | -0.125 striatal binding ratio | Standard Error 0.0155 |
p-value: 0.827495% CI: [-0.0548, 0.0438]Mixed Model for Repeated Measures
p-value: 0.667195% CI: [-0.0504, 0.0323]Mixed Model for Repeated Measures
p-value: 0.131395% CI: [-0.0751, 0.0098]Mixed Model for Repeated Measures
Secondary
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator 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; is a medically important event.
Time frame: Up to 3 years
Population: The safety population was defined as all participants who received at least one dose of study treatment (BIIB054).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PC Period: Placebo | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 77.1 percentage of participants |
| PC Period: Placebo | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8.3 percentage of participants |
| PC Period: BIIB054 250 mg (Early Start) | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10.9 percentage of participants |
| PC Period: BIIB054 250 mg (Early Start) | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 85.5 percentage of participants |
| PC Period: BIIB054 1250 mg (Early Start) | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 89.2 percentage of participants |
| PC Period: BIIB054 1250 mg (Early Start) | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8.8 percentage of participants |
| PC Period: BIIB054 3500 mg (Early Start) | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 93.0 percentage of participants |
| PC Period: BIIB054 3500 mg (Early Start) | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 12.0 percentage of participants |
Secondary
Percentage of Participants With Anti-BIIB054 Antibodies in the Serum
Time frame: Up to Week 144
Population: The analysis population for immunogenicity was defined as all participants in the safety population. As prespecified in the protocol, the data for the delayed start BIIB054 were pooled from Placebo/BIIB054 250/1250/3500 mg for the analysis of this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PC Period: Placebo | Percentage of Participants With Anti-BIIB054 Antibodies in the Serum | 0 percentage of participants |
| PC Period: BIIB054 250 mg (Early Start) | Percentage of Participants With Anti-BIIB054 Antibodies in the Serum | 1.8 percentage of participants |
| PC Period: BIIB054 1250 mg (Early Start) | Percentage of Participants With Anti-BIIB054 Antibodies in the Serum | 0 percentage of participants |
| PC Period: BIIB054 3500 mg (Early Start) | Percentage of Participants With Anti-BIIB054 Antibodies in the Serum | 0 percentage of participants |
Secondary
Serum Concentration of BIIB054
Time frame: Pre-dose and 1 hour post-dose of Baseline, Weeks 4, 8, 12, 16, 24, 32, 36, 44, 52, 60, 68, 84, 96, 120 and 144
Population: The pharmacokinetic (PK) population was defined as all participants in the ITT population who had at least one measurable BIIB054 concentration in serum or cerebrospinal fluid (CSF). Number analyzed is the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 4 (1 Hour Post-dose) | 97.09 micrograms per milliliter (ug/mL) | Standard Deviation 19.711 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 60 (Pre-dose) | 43.41 micrograms per milliliter (ug/mL) | Standard Deviation 15.973 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 24 (Pre-dose) | 43.31 micrograms per milliliter (ug/mL) | Standard Deviation 12.906 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Baseline (1 Hour Post-dose) | 75.02 micrograms per milliliter (ug/mL) | Standard Deviation 15.829 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 52 (1 Hour Post-dose) | 114.59 micrograms per milliliter (ug/mL) | Standard Deviation 25.913 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 24 (1 Hour Post-dose) | 125.79 micrograms per milliliter (ug/mL) | Standard Deviation 36.695 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 96 (1 Hour Post-dose) | 122.00 micrograms per milliliter (ug/mL) | Standard Deviation 29.527 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 52 (Pre-dose) | 46.70 micrograms per milliliter (ug/mL) | Standard Deviation 19.343 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 32 (Pre-dose) | 42.69 micrograms per milliliter (ug/mL) | Standard Deviation 13.486 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 8 (Pre-dose) | 29.73 micrograms per milliliter (ug/mL) | Standard Deviation 8.371 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 44 (1 Hour Post-dose) | 143.33 micrograms per milliliter (ug/mL) | Standard Deviation 41.004 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 32 (1 Hour Post-dose) | 139.00 micrograms per milliliter (ug/mL) | Standard Deviation 34.758 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Baseline (Pre-dose) | 0.00 micrograms per milliliter (ug/mL) | Standard Deviation 0 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 44 (Pre-dose) | 58.17 micrograms per milliliter (ug/mL) | Standard Deviation 22.774 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 36 (Pre-dose) | 45.77 micrograms per milliliter (ug/mL) | Standard Deviation 11.867 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 96 (Pre-dose) | 41.25 micrograms per milliliter (ug/mL) | Standard Deviation 15.345 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 36 (1 Hour Post-dose) | 123.67 micrograms per milliliter (ug/mL) | Standard Deviation 29.536 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 8 (1 Hour Post-dose) | 103.69 micrograms per milliliter (ug/mL) | Standard Deviation 26.964 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 120 (1 Hour Post-dose) | 119.67 micrograms per milliliter (ug/mL) | Standard Deviation 15.629 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 84 (1 Hour Post-dose) | 134.91 micrograms per milliliter (ug/mL) | Standard Deviation 33.035 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 12 (Pre-dose) | 36.76 micrograms per milliliter (ug/mL) | Standard Deviation 11.83 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 4 (Pre-dose) | 20.37 micrograms per milliliter (ug/mL) | Standard Deviation 5.004 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 84 (Pre-dose) | 47.00 micrograms per milliliter (ug/mL) | Standard Deviation 15.535 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 12 (1 Hour Post-dose) | 112.61 micrograms per milliliter (ug/mL) | Standard Deviation 27.378 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 60 (1 Hour Post-dose) | 122.55 micrograms per milliliter (ug/mL) | Standard Deviation 29.374 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 68 (1 Hour Post-dose) | 171.50 micrograms per milliliter (ug/mL) | Standard Deviation 44.548 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 16 (Pre-dose) | 40.82 micrograms per milliliter (ug/mL) | Standard Deviation 11.421 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 120 (Pre-dose) | 34.98 micrograms per milliliter (ug/mL) | Standard Deviation 12.042 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 68 (Pre-dose) | 706.25 micrograms per milliliter (ug/mL) | Standard Deviation 966.969 |
| PC Period: Placebo | Serum Concentration of BIIB054 | Week 16 (1 Hour Post-dose) | 117.08 micrograms per milliliter (ug/mL) | Standard Deviation 27.401 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 144 (1 Hour Post-dose) | 721.00 micrograms per milliliter (ug/mL) | — |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 60 (1 Hour Post-dose) | 657.94 micrograms per milliliter (ug/mL) | Standard Deviation 149.654 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Baseline (Pre-dose) | 7.47 micrograms per milliliter (ug/mL) | Standard Deviation 51.281 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Baseline (1 Hour Post-dose) | 374.79 micrograms per milliliter (ug/mL) | Standard Deviation 86.004 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 4 (Pre-dose) | 95.36 micrograms per milliliter (ug/mL) | Standard Deviation 27.882 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 4 (1 Hour Post-dose) | 468.56 micrograms per milliliter (ug/mL) | Standard Deviation 190.589 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 8 (Pre-dose) | 169.79 micrograms per milliliter (ug/mL) | Standard Deviation 68.025 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 8 (1 Hour Post-dose) | 543.91 micrograms per milliliter (ug/mL) | Standard Deviation 143.212 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 12 (Pre-dose) | 195.16 micrograms per milliliter (ug/mL) | Standard Deviation 51.02 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 12 (1 Hour Post-dose) | 569.41 micrograms per milliliter (ug/mL) | Standard Deviation 141.25 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 16 (Pre-dose) | 201.33 micrograms per milliliter (ug/mL) | Standard Deviation 73.451 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 16 (1 Hour Post-dose) | 614.85 micrograms per milliliter (ug/mL) | Standard Deviation 186.892 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 24 (Pre-dose) | 235.69 micrograms per milliliter (ug/mL) | Standard Deviation 84.454 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 24 (1 Hour Post-dose) | 664.26 micrograms per milliliter (ug/mL) | Standard Deviation 209.251 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 32 (Pre-dose) | 260.35 micrograms per milliliter (ug/mL) | Standard Deviation 104.397 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 32 (1 Hour Post-dose) | 626.16 micrograms per milliliter (ug/mL) | Standard Deviation 164.497 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 36 (Pre-dose) | 262.80 micrograms per milliliter (ug/mL) | Standard Deviation 85.052 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 36 (1 Hour Post-dose) | 665.60 micrograms per milliliter (ug/mL) | Standard Deviation 145.235 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 44 (Pre-dose) | 280.40 micrograms per milliliter (ug/mL) | Standard Deviation 116.59 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 44 (1 Hour Post-dose) | 582.40 micrograms per milliliter (ug/mL) | Standard Deviation 194.431 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 52 (Pre-dose) | 232.08 micrograms per milliliter (ug/mL) | Standard Deviation 87.529 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 52 (1 Hour Post-dose) | 645.36 micrograms per milliliter (ug/mL) | Standard Deviation 264.27 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 60 (Pre-dose) | 254.52 micrograms per milliliter (ug/mL) | Standard Deviation 88.446 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 68 (Pre-dose) | 202.33 micrograms per milliliter (ug/mL) | Standard Deviation 34.21 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 68 (1 Hour Post-dose) | 576.33 micrograms per milliliter (ug/mL) | Standard Deviation 85.29 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 84 (Pre-dose) | 255.54 micrograms per milliliter (ug/mL) | Standard Deviation 81.407 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 84 (1 Hour Post-dose) | 648.62 micrograms per milliliter (ug/mL) | Standard Deviation 120.163 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 96 (Pre-dose) | 274.56 micrograms per milliliter (ug/mL) | Standard Deviation 71.718 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 96 (1 Hour Post-dose) | 682.30 micrograms per milliliter (ug/mL) | Standard Deviation 123.653 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 120 (Pre-dose) | 279.00 micrograms per milliliter (ug/mL) | Standard Deviation 99.499 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 120 (1 Hour Post-dose) | 769.83 micrograms per milliliter (ug/mL) | Standard Deviation 279.182 |
| PC Period: BIIB054 250 mg (Early Start) | Serum Concentration of BIIB054 | Week 144 (Pre-dose) | 365.00 micrograms per milliliter (ug/mL) | — |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 16 (1 Hour Post-dose) | 1739.98 micrograms per milliliter (ug/mL) | Standard Deviation 506.346 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Baseline (Pre-dose) | 0.01 micrograms per milliliter (ug/mL) | Standard Deviation 0.065 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 60 (Pre-dose) | 724.77 micrograms per milliliter (ug/mL) | Standard Deviation 314.854 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 60 (1 Hour Post-dose) | 1905.43 micrograms per milliliter (ug/mL) | Standard Deviation 494.136 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 16 (Pre-dose) | 642.06 micrograms per milliliter (ug/mL) | Standard Deviation 194.288 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 96 (1 Hour Post-dose) | 1822.50 micrograms per milliliter (ug/mL) | Standard Deviation 475.682 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 68 (Pre-dose) | 1362.50 micrograms per milliliter (ug/mL) | Standard Deviation 533.866 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 12 (1 Hour Post-dose) | 1632.29 micrograms per milliliter (ug/mL) | Standard Deviation 459.839 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 4 (Pre-dose) | 306.20 micrograms per milliliter (ug/mL) | Standard Deviation 95.257 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 68 (1 Hour Post-dose) | 2305.00 micrograms per milliliter (ug/mL) | Standard Deviation 1025.305 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 12 (Pre-dose) | 580.43 micrograms per milliliter (ug/mL) | Standard Deviation 185.761 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 120 (1 Hour Post-dose) | 1717.14 micrograms per milliliter (ug/mL) | Standard Deviation 320.037 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 84 (Pre-dose) | 746.43 micrograms per milliliter (ug/mL) | Standard Deviation 249.77 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 8 (1 Hour Post-dose) | 1591.57 micrograms per milliliter (ug/mL) | Standard Deviation 465.798 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 120 (Pre-dose) | 727.29 micrograms per milliliter (ug/mL) | Standard Deviation 116.793 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 36 (Pre-dose) | 819.83 micrograms per milliliter (ug/mL) | Standard Deviation 328.774 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 84 (1 Hour Post-dose) | 1942.02 micrograms per milliliter (ug/mL) | Standard Deviation 501.095 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 36 (1 Hour Post-dose) | 1916.84 micrograms per milliliter (ug/mL) | Standard Deviation 543.373 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 32 (1 Hour Post-dose) | 1985.71 micrograms per milliliter (ug/mL) | Standard Deviation 497.545 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 8 (Pre-dose) | 495.79 micrograms per milliliter (ug/mL) | Standard Deviation 153.357 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 44 (Pre-dose) | 858.43 micrograms per milliliter (ug/mL) | Standard Deviation 349.573 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 32 (Pre-dose) | 772.75 micrograms per milliliter (ug/mL) | Standard Deviation 299.703 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Baseline (1 Hour Post-dose) | 1137.28 micrograms per milliliter (ug/mL) | Standard Deviation 335.336 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 44 (1 Hour Post-dose) | 2066.25 micrograms per milliliter (ug/mL) | Standard Deviation 579.555 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 24 (1 Hour Post-dose) | 1867.92 micrograms per milliliter (ug/mL) | Standard Deviation 470.283 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 96 (Pre-dose) | 654.70 micrograms per milliliter (ug/mL) | Standard Deviation 262.926 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 52 (Pre-dose) | 787.35 micrograms per milliliter (ug/mL) | Standard Deviation 341.229 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 24 (Pre-dose) | 724.60 micrograms per milliliter (ug/mL) | Standard Deviation 228.295 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 4 (1 Hour Post-dose) | 1354.19 micrograms per milliliter (ug/mL) | Standard Deviation 364.468 |
| PC Period: BIIB054 1250 mg (Early Start) | Serum Concentration of BIIB054 | Week 52 (1 Hour Post-dose) | 1920.78 micrograms per milliliter (ug/mL) | Standard Deviation 479.511 |