Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease (NCT NCT04777331)

Last Updated: 2025-12-26

Results Overview

Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

586 participants

Primary outcome timeframe

From study start to end of DBT period to at least 76 weeks

Results posted on

2025-12-26

Participant Flow

A total of 586 participants with early-stage Parkinson's disease (PD) took part in the study across 110 investigative sites in 9 countries. The study consisted of double-blind treatment (DBT), where participants were randomized in 1:1 ratio to receive prasinezumab or placebo and an optional open-label extension (OLE).

After completing the DBT period, consenting \& eligible participants entered the OLE period to receive prasinezumab. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. The study is still ongoing.

Participant milestones

Participant milestones
Measure	DBT Period: Placebo Participants received prasinezumab matching placebo as an intravenous (IV) infusion, every 4 weeks (Q4W) up to at least 76 weeks.	DBT Period: Prasinezumab Participants received prasinezumab, 1500 milligrams (mg), as an intravenous (IV) infusion, Q4W up to at least 76 weeks.	OLE Period: Prasinezumab Eligible and consenting participants who completed the DBT period enrolled in the OLE period, to receive prasinezumab, 1500 mg, as an IV infusion, Q4W up to 104 weeks.
DBT Period STARTED	293	293	0
DBT Period Safety Analysis Set (SAS)	290	292	0
DBT Period COMPLETED	273	277	0
DBT Period NOT COMPLETED	20	16	0
OLE Period STARTED	0	0	534
OLE Period COMPLETED	0	0	0
OLE Period NOT COMPLETED	0	0	534

Reasons for withdrawal

Reasons for withdrawal
Measure	DBT Period: Placebo Participants received prasinezumab matching placebo as an intravenous (IV) infusion, every 4 weeks (Q4W) up to at least 76 weeks.	DBT Period: Prasinezumab Participants received prasinezumab, 1500 milligrams (mg), as an intravenous (IV) infusion, Q4W up to at least 76 weeks.	OLE Period: Prasinezumab Eligible and consenting participants who completed the DBT period enrolled in the OLE period, to receive prasinezumab, 1500 mg, as an IV infusion, Q4W up to 104 weeks.
DBT Period Death	2	1	0
DBT Period Reason not Specified	1	1	0
DBT Period Physician Decision	4	0	0
DBT Period Withdrawal by Subject	12	11	0
DBT Period Randomized but not Treated	1	3	0
OLE Period Ongoing in OLE	0	0	534

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBT Period: Placebo n=293 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=293 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.	Total n=586 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 7.5 • n=30 Participants	64.0 years STANDARD_DEVIATION 7.2 • n=30 Participants	64.2 years STANDARD_DEVIATION 7.3 • n=60 Participants
Sex: Female, Male Female	104 Participants n=30 Participants	110 Participants n=30 Participants	214 Participants n=60 Participants
Sex: Female, Male Male	189 Participants n=30 Participants	183 Participants n=30 Participants	372 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=30 Participants	33 Participants n=30 Participants	64 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	246 Participants n=30 Participants	241 Participants n=30 Participants	487 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=30 Participants	19 Participants n=30 Participants	35 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	2 Participants n=30 Participants	4 Participants n=30 Participants	6 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	2 Participants n=30 Participants	0 Participants n=30 Participants	2 Participants n=60 Participants
Race (NIH/OMB) White	278 Participants n=30 Participants	275 Participants n=30 Participants	553 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=30 Participants	14 Participants n=30 Participants	25 Participants n=60 Participants

PRIMARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: FAS included all randomized participants, with participants grouped according to their randomized treatment.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=293 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=293 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	49.7 weeks Interval 40.1 to 58.1	61.1 weeks Interval 52.3 to 71.9

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: FAS included all randomized participants, with participants grouped according to their randomized treatment.

Time to worsening of the motor function was defined as ≥3 points increase in MDS-UPDRS Part II score from baseline in the presence of a confirmed motor progression event. For the confirmed motor progression event the definition is as per primary endpoint definition. MDS-UPDRS Part II assesses motor experiences of daily living \& contained 13 questions answered by participant. For each question a numeric score is assigned between 0-4, 0 = Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Score range: 0 to 52 with higher score=severe impairment.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=293 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=293 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event	88.3 weeks Interval 62.7 to 105.1	112.1 weeks Interval 81.1 to Upper limit of 95 % confidence interval (CI) was not estimable due to insufficient follow-up duration to observe events and a very small number of individuals at risk by the end of the DBT period.

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: FAS included all randomized participants, with participants grouped according to their randomized treatment.

The PGI is a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (PGI-C) was intended to measure health state changes as reported by the participant on a 7-point scale (1=Very much improved to 7=Very much worse). The meaningfulness of the change was assessed and reported by the participant.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=293 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=293 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale	36.1 weeks Interval 29.9 to 42.1	44.4 weeks Interval 38.1 to 52.1

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: FAS included all randomized participants, with participants grouped according to their randomized treatment.

The CGI was a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (CGI-C) was intended to measure health state changes as reported by the clinician on a 7-point scale (1=Very much improved to 7=Very much worse).

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=293 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=293 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale	52.1 weeks Interval 44.1 to 59.9	60.6 weeks Interval 56.1 to 67.3

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: FAS included all randomized participants, with participants grouped according to their randomized treatment.

MDS-UPDRS Part IV assessed motor complications of symptomatic treatment, dyskinesias, and motor fluctuations. The rater completed this assessment only for participants on L-Dopa treatment.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=293 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=293 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV	91.1 weeks Interval 77.0 to 107.6	100.1 weeks Interval 81.0 to 117.1

SECONDARY outcome

Timeframe: From baseline up to Week 76

Population: FAS included all randomized participants, with participants grouped according to their randomized treatment. Overall number analyzed is the number of participants with data available for analysis.

MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=266 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=266 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score	4.00 Units on a scale Standard Error 0.592	3.61 Units on a scale Standard Error 0.597

SECONDARY outcome

Timeframe: From baseline up to Week 76

MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. For bradykinesia, subscore ranges from 0 to 52, while rigidity subscore ranges from 0 to 20, with higher scores indicating greater impairment. Change in bradykinesia and rigidity was assessed in "OFF" medication state. Adjusted mean is reported here.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=267 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=266 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore	2.77 Units on a scale Standard Error 0.476	2.85 Units on a scale Standard Error 0.479

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: Safety Analysis Set (SAS) included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis.

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. Number of participants with atleast 1 AE and SAE are reported here.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=292 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	34 Participants	34 Participants
DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	260 Participants	267 Participants

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis.

An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \& aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=292 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Number of Participants With Adverse Events of Special Interest (AESI)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=292 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Number of Participants With Treatment Discontinuation Due to AEs	3 Participants	2 Participants

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=292 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Number of Participants With Infusion Related Reactions (IRRs)	37 Participants	32 Participants

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received.

C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab n=292 Participants Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Passive: Wish to be Dead	6 Participants	5 Participants
DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Non-specific Active Suicidal Thoughts	2 Participants	2 Participants
DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act	3 Participants	0 Participants
DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Self-injurious Behavior, no Suicidal Intent	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76

Population: Pharmacokinetic (PK) Analysis Set (PAS) included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS)	313.5 micrograms/milliliter (µg/mL) Interval 217.3 to 514.9	—

SECONDARY outcome

Timeframe: Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76

Population: PAS included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS)	28.7 µg/mL Interval 12.1 to 60.9	—

SECONDARY outcome

Timeframe: Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76

Population: PAS included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=290 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS)	49384 hoursmicrogram/milliter (hµg/mL) Interval 34850.0 to 82330.0	—

SECONDARY outcome

Timeframe: From study start to end of DBT period to at least 76 weeks

Population: Immunogenicity population included all participants on active treatment with at least one ADA assessment. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	DBT Period: Placebo n=289 Participants Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.	DBT Period: Prasinezumab Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment	0.3 percentage of participants	—

SECONDARY outcome

Timeframe: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)

An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated ALT \& AST in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)

Outcome measures

Outcome data not reported

Adverse Events

DBT Period: Placebo

Serious events: 34 serious events

Other events: 205 other events

Deaths: 2 deaths

DBT Period: Prasinezumab

Serious events: 34 serious events

Other events: 206 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER