Evicenter
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Juvmo (tavapadon)

Parkinson's disease

Also known as CVL-751
Manufacturer
AbbVie
Regulatory submission
NDA submitted September 2025
Last updated
217 sources

Product information and disease descriptionPlace of product in therapyDisease descriptionBurden of Parkinson's disease

Humanistic burden and health-related quality of life

14 evidence topics · 10 sources

Non-motor symptoms and health-related quality of life

“The sample was made up of 411 Parkinson’s disease patients, recruited in 12 movement disorders clinics across 10 countries.” (opens the source at this quote in a new tab)

“Mean age (±standard deviation) was 64.48 (±9.92) years old, and disease duration was 8.07 (±5.75) years.” (opens the source at this quote in a new tab)

“Higher scores mean poorer HRQoL.” (opens the source at this quote in a new tab)

“For each group, PDQ-39 and EQ-5D means and standard deviations were calculated, and group differences were assessed by the Mann-Whitney test.” (opens the source at this quote in a new tab)

“The Benjamini-Hochberg test for multiple comparisons was applied.” (opens the source at this quote in a new tab)

“Nocturia (68.4% of the sample), fatigue (65.9%), and dribbling saliva (56.7%), were the most frequent complaints.” (opens the source at this quote in a new tab)

“The mean number of non-motor symptoms per patient was 11.80 ± 6.03 (range: 0–29), and there was a high correlation between the number of nonmotor symptoms and PDQ-39 and EQ-5D (Table 4).” (opens the source at this quote in a new tab)

“For each NMSS domain, patients with symptoms had significantly worse HRQoL scores than patients without symptoms.” (opens the source at this quote in a new tab)

“SCOPA-motor (total, motor examination, and activities of daily living subscales) reached the strongest relationship with the EQ-5D index (rS = from −0.58 to −0.67).” (opens the source at this quote in a new tab)

“The correlation between NMSS and SCOPA-Motor was 0.43.” (opens the source at this quote in a new tab)

“For each NMSS domain, patients with symptoms had significantly worse HRQoL than patients with no symptoms, except for the EQ-5D in the sexual dysfunction domain and the EQ-5D VAS in the urinary domain (Table 5).” (opens the source at this quote in a new tab)

“The corresponding models accounted for 53% (EQ-5D) and 59% (PDQ-39) of the variance.” (opens the source at this quote in a new tab)

“NMSS score had the strongest influence on HRQoL as measured by the PDQ-39, whereas considering EQ5D, both SCOPA-motor examination and NMSS were the strongest predictors and almost equivalent.” (opens the source at this quote in a new tab)

“In the models that included the NMSS domains as independent variables, mood/apathy, sleep/fatigue, and miscellaneous domains were the most significant factors for both the PDQ-39 SI and the EQ-5D index, accounting for 50% and 38% of the variance, respectively.” (opens the source at this quote in a new tab)

“Most of the patient population in the study was on dopaminergic therapy and, therefore, the impact of the motor manifestations may be neutralized by effective antiparkinsonian effect.” (opens the source at this quote in a new tab)

“The results show that non-motor symptoms have, as a whole, a greater impact on HRQoL than motor symptoms and non-motor symptoms progression contributes importantly to HRQoL decline in patients with Parkinson's disease.” (opens the source at this quote in a new tab)

NMSS domainWith symptoms, nWithout symptoms, nPDQ-39 SI, with symptoms, mean ± SDPDQ-39 SI, without symptoms, mean ± SDPDQ-39 SI, PEQ-5D index, with symptoms, mean ± SDEQ-5D index, without symptoms, mean ± SDEQ-5D index, PEQ-5D VAS, with symptoms, mean ± SDEQ-5D VAS, without symptoms, mean ± SDEQ-5D VAS, P
Cardiovascular“173”“238”“32.45 ± 17.85”“24.79 ± 15.66”“<0.0001”“0.48 ± 0.37”“0.62 ± 0.32”“0.0001”“61.49 ± 21.23”“65.17 ± 23.01”“0.05”
Sleep/fatigue“356”“54”“30.11 ± 16.80”“14.48 ± 11.57”“<0.0001”“0.52 ± 0.35”“0.79 ± 0.20”“<0.0001”“61.75 ± 21.77”“75.74 ± 22.45”“<0.0001”
Mood/apathy“310”“100”“31.31 ± 16.87”“17.64 ± 13.01”“<0.0001”“0.50 ± 0.35”“0.74 ± 0.27”“<0.0001”“61.66 ± 22.01”“70.51 ± 21.21”“0.0002”
Perceptual problems/hallucinations“123”“288”“36.89 ± 17.25”“24.22 ± 15.47”“<0.0001”“0.38 ± 0.39”“0.63 ± 0.30”“<0.0001”“57.15 ± 25.19”“66.40 ± 20.39”“0.0004”
Attention/memory“296”“115”“30.65 ± 16.93”“21.27 ± 15.37”“<0.0001”“0.52 ± 0.36”“0.66 ± 0.30”“0.0005”“61.35 ± 22.21”“69.52 ± 21.58”“0.0005”
Gastrointestinal“302”“109”“31.02 ± 17.84”“19.76 ± 10.92”“<0.0001”“0.49 ± 0.36”“0.74 ± 0.23”“<0.0001”“61.00 ± 22.48”“71.04 ± 20.16”“<0.0001”
Urinary“338”“73”“29.52 ± 17.44”“21.12 ± 12.97”“0.0002”“0.54 ± 0.36”“0.66 ± 0.28”“0.001”“62.82 ± 22.56”“67.38 ± 20.87”“0.13”
Sexual dysfunction“177”“234”“29.71 ± 15.97”“26.75 ± 17.71”“0.03”“0.53 ± 0.34”“0.58 ± 0.35”“0.09”“63.17 ± 21.92”“63.94 ± 22.65”“0.53”
Miscellaneous“99”“312”“30.38 ± 17.36”“20.61 ± 13.54”“<0.0001”“0.50 ± 0.36”“0.73 ± 0.25”“<0.0001”“61.61 ± 22.32”“70.02 ± 21.20”“0.0006”
Multiple linear regression models of PDQ-39 and EQ-5D scores on motor and non-motor symptom measures
Model (dependent variable)Adjusted R² of the modelIndependent variableStandardized betatSig.
PDQ-39 SI“0.59”Constant (unstandardized value)“(23.76)”“5.55”“0.000”
PDQ-39 SI“0.59”NMSS total“0.52”“13.64”“0.000”
PDQ-39 SI“0.59”SCOPA-motor complications“0.20”“4.81”“0.000”
PDQ-39 SI“0.59”SCOPA-motor examination“0.17”“4.15”“0.000”
EQ-5D index“0.53”Constant (unstandardized value)“(0.83)”“9.24”“0.000”
EQ-5D index“0.53”SCOPA-motor examination“−0.38”“−9.11”“0.000”
EQ-5D index“0.53”NMSS total“−0.37”“−8.74”“0.000”
EQ-5D index“0.53”SCOPA-motor complications“−0.12”“−2.71”“0.000”
Motor fluctuations and dyskinesia and health-related quality of life in five European countries

“Data were collected cross-sectionally in clinical practice settings via nationally representative samples of specialized physicians (neurologists, plus geriatricians in the UK) and their PD patients between March and July, 2008.” (opens the source at this quote in a new tab)

“In total, 817 patients were included in our analyses.” (opens the source at this quote in a new tab)

“All multivariable models were adjusted for age, gender, HY stage, disease duration, and country.” (opens the source at this quote in a new tab)

“To facilitate the comparison of the regression coefficients (β) across the QoL instruments the EQ-5D IS was rescaled from 0 (poor QoL) to 100 (good QoL).” (opens the source at this quote in a new tab)

“For the primary hypotheses, the association of motor complication subtypes with QoL, the global significance level was set at 5% and was adjusted per outcome using a Bonferroni correction. A difference was considered statistically significant if p < 0.025.” (opens the source at this quote in a new tab)

“PDQ-39 scores range from 0 to 100. Contrary to the EQ-5D lower values indicate better QoL.” (opens the source at this quote in a new tab)

“These analyses were regarded as explorative, and the p-values of the corresponding regression models are presented for descriptive reasons only.” (opens the source at this quote in a new tab)

“Thirty-three percent of the patients (varying from 23% in Italy to 58% in France) suffered from motor complications, either a single subtype or a combination of different subtypes.” (opens the source at this quote in a new tab)

“Twenty percent of all patients suffered from a single motor complication, 10.0% from two, 2.3% from three, and 0.5% from all four types of motor complications.” (opens the source at this quote in a new tab)

“Twenty-eight percent of all patients had off-times.” (opens the source at this quote in a new tab)

“The mean EQ-5D IS of the total sample was 0.7 (SD 0.2) based on the ratings in the dimensions mobility (33.9% of the patients reported no, 64.8% some,1.2% extreme problems), self-care (55.3% no, 39.9% some, 4.8% extreme problems), usual activities (36.4%, 57.8% some, 5.8% extreme problems), pain/discomfort (45.4% no, 51.1% some, 3.4% extreme problems), and anxiety/depression (54.1% no, 41.6% some, 4.3% extreme problems). The mean PDQ-39 SI was 25.4 (SD 18.5).” (opens the source at this quote in a new tab)

“On-off fluctuations were associated with a 7.1 percentage point decrease in the EQ-5D (p < 0.001) and a 3.6 percentage point deterioration in the PDQ-39 (p = 0.01).” (opens the source at this quote in a new tab)

“None of the dyskinesia subtypes had a significant effect on the EQ-5D IS or the PDQ-39 SI (Table 2).” (opens the source at this quote in a new tab)

“Sensitivity analyses considering motor complication severity indicated that compared to patients without on-off fluctuations the detrimental effect of on-off fluctuations was greater in patients with more severe complications (mild: β=−6.0, p < 0.01; moderate: β=−9.0, p < 0.001; severe: β = −3.2, p = 0.58). A linear trend was, however, not confirmed in the trend analysis (p = 0.48). The same was true for the severity of on-off fluctuations and the PDQ-39 SI (mild: β=2.9, p = 0.09; moderate: β = 5.4, p = 0.01; severe: β = 7.7, p = 0.1; test for linear trend p = 0.07).” (opens the source at this quote in a new tab)

“Dyskinesias were not seen to affect global QoL scores, but had detrimental effects on the PDQ-39 dimensions activities of daily living, cognitions, stigma, and bodily discomfort.” (opens the source at this quote in a new tab)

“In subgroup analyses that excluded patients with present symptoms of depression and/or cognitive impairment the results did not notably alter.” (opens the source at this quote in a new tab)

“On-off fluctuations were associated with poorer EQ-5D IS (β = −6.4, p = 0.003) and PDQ-39 SI (β = 4.5, p = 0.01) whereas dyskinesias did not impact QoL.” (opens the source at this quote in a new tab)

“The motor complications observed in our sample were mainly mild or moderate limiting the generalizability of results for patients with more severe motor complications as well as the power of the linear trend tests.” (opens the source at this quote in a new tab)

“The Adelphi PD Specific Programme is an independent study conducted by the Adelphi group on behalf of Solvay Pharmaceuticals.” (opens the source at this quote in a new tab)

Multivariable associations of motor complication subtypes with EQ-5D and PDQ-39 scores, all subtypes and outcomes
Motor complication subtypeOutcomeRegression coefficient (β)95% CIp-Value
On-off fluctuationsEQ-5D index score (rescaled 0 to 100; higher scores represent better QoL)“−7.1”“−10.6; −3.6”“<0.001”
On-off fluctuationsPDQ-39 summary index (0 to 100; higher scores represent worse QoL)“3.6”“0.7; 6.5”“0.01”
On-off fluctuationsPDQ-39 mobility“8.1”“4.0; 12.2”“<0.001”
On-off fluctuationsPDQ-39 activities of daily living“7.3”“3.2; 11.5”“<0.001”
On-off fluctuationsPDQ-39 emotional wellbeing“3.2”“−0.5; 6.9”“0.09”
On-off fluctuationsPDQ-39 stigma“2.5”“−1.7; 6.7”“0.23”
On-off fluctuationsPDQ-39 social support“2.3”“−1.1; 5.7”“0.19”
On-off fluctuationsPDQ-39 cognitions“2.9”“−0.4; 6.1”“0.08”
On-off fluctuationsPDQ-39 communication“2.4”“−1.0; 5.8”“0.17”
On-off fluctuationsPDQ-39 bodily discomfort“2.5”“−1.3; 6.3”“0.20”
Peak-dose dyskinesiasEQ-5D index score (rescaled 0 to 100; higher scores represent better QoL)“−2.9”“−6.9; 1.2”“0.17”
Peak-dose dyskinesiasPDQ-39 summary index (0 to 100; higher scores represent worse QoL)“2.4”“−0.9; 5.7”“0.16”
Peak-dose dyskinesiasPDQ-39 mobility“3.3”“−1.3; 8.0”“0.16”
Peak-dose dyskinesiasPDQ-39 activities of daily living“5.9”“1.2; 10.7”“0.01”
Peak-dose dyskinesiasPDQ-39 emotional wellbeing“2.7”“−1.6; 7.0”“0.22”
Peak-dose dyskinesiasPDQ-39 stigma“−0.4”“−5.3; 4.4”“0.86”
Peak-dose dyskinesiasPDQ-39 social support“0.1”“−3.8; 4.0”“0.96”
Peak-dose dyskinesiasPDQ-39 cognitions“4.0”“0.3; 7.7”“0.03”
Peak-dose dyskinesiasPDQ-39 communication“3.6”“−0.3; 7.6”“0.07”
Peak-dose dyskinesiasPDQ-39 bodily discomfort“−2.2”“−6.6; 2.2”“0.32”
Biphasic dyskinesiasEQ-5D index score (rescaled 0 to 100; higher scores represent better QoL)“−2.4”“−10.6; 5.8”“0.56”
Biphasic dyskinesiasPDQ-39 summary index (0 to 100; higher scores represent worse QoL)“6.1”“−0.9; 13.0”“0.09”
Biphasic dyskinesiasPDQ-39 mobility“5.4”“−4.3; 15.1”“0.28”
Biphasic dyskinesiasPDQ-39 activities of daily living“4.2”“−5.4; 13.7”“0.39”
Biphasic dyskinesiasPDQ-39 emotional wellbeing“5.9”“−3.0; 14.7”“0.19”
Biphasic dyskinesiasPDQ-39 stigma“12.6”“2.7; 22.6”“0.01”
Biphasic dyskinesiasPDQ-39 social support“2.6”“−5.4; 10.6”“0.53”
Biphasic dyskinesiasPDQ-39 cognitions“0.5”“−7.2; 8.2”“0.90”
Biphasic dyskinesiasPDQ-39 communication“−0.3”“−8.2; 7.7”“0.95”
Biphasic dyskinesiasPDQ-39 bodily discomfort“2.3”“−6.6; 11.2”“0.61”
Off-dystoniasEQ-5D index score (rescaled 0 to 100; higher scores represent better QoL)“−0.02”“−5.9; 5.8”“1.00”
Off-dystoniasPDQ-39 summary index (0 to 100; higher scores represent worse QoL)“1.6”“−3.1; 6.4”“0.51”
Off-dystoniasPDQ-39 mobility“1.9”“−4.9; 8.6”“0.59”
Off-dystoniasPDQ-39 activities of daily living“1.4”“−5.4; 8.2”“0.68”
Off-dystoniasPDQ-39 emotional wellbeing“3.5”“−2.7; 9.7”“0.27”
Off-dystoniasPDQ-39 stigma“4.6”“−2.4; 11.5”“0.20”
Off-dystoniasPDQ-39 social support“0.5”“−5.1; 6.1”“0.85”
Off-dystoniasPDQ-39 cognitions“−2.9”“−8.3; 2.5”“0.29”
Off-dystoniasPDQ-39 communication“−0.4”“−6.2; 5.3”“0.88”
Off-dystoniasPDQ-39 bodily discomfort“7.4”“1.1; 13.8”“0.02”
Motor complication subtypes and PDQ-39 dimensions

“The impact of motor complications of Parkinson’s disease (PD), especially levodopa-induced dyskinesias, on quality of life (QL) was studied in 143 patients with PD.” (opens the source at this quote in a new tab)

“Two groups of patients were excluded, those having undergone surgery of the basal ganglia and those having an alteration of cognitive functions (Mini-Mental State Examination score lower than 24).” (opens the source at this quote in a new tab)

“The range of possible values of each QL dimension is 0 (best QL) to 100 (worst QL), and the PDQ-SI is obtained by adding the dimension scores and reducing the range to 0 to 100.” (opens the source at this quote in a new tab)

“Motor complications significantly worsened the PDQ-39 Summary Index (PDQ-SI) of patients with PD.” (opens the source at this quote in a new tab)

“Morning akinesia, end-of-dose fluctuations, and “unpredictable offs” decreased QL on the dimensions of Mobility, Activities of Daily Living, Stigma, and Communication.” (opens the source at this quote in a new tab)

“Nocturnal akinesia led to a deterioration of all dimensions of the PDQ-39.” (opens the source at this quote in a new tab)

“All the motor fluctuations studied significantly worsened the PDQ-SI.” (opens the source at this quote in a new tab)

“Apart from morning dystonias, all the self-reported LIDs studied (peak dose, diphasic, and off) were significantly related to a higher PDQ-SI, as was the dyskinesia score.” (opens the source at this quote in a new tab)

“We were particularly surprised by the impact of nocturnal akinesia, which often faded into the background at the consultation.” (opens the source at this quote in a new tab)

Motor complicationParticipants with the complication, nPercentage (of all participants for any fluctuation or any dyskinesia; of participants in that class for each subtype)PDQ-SI mean, with the complicationPDQ-SI mean, without the complicationPDQ-SI, P (Student's t test)
Any motor fluctuation“94”“66”Not reportedNot reportedNot reported
Early-morning akinesia“55”“58.5”“40.9”“33.6”“0.005”
Nocturnal akinesia“54”“57.5”“44.7”“31.3”“<0.0001”
End-of-dose fluctuations“74”“78.7”“41”“31.6”“0.0002”
Paradoxical fluctuations“47”“50”“44.2”“32.6”“<0.0001”
Unpredictable offs“34”“36.2”“45.5”“33.5”“<0.0001”
Any levodopa-induced dyskinesia“81”“57”Not reportedNot reportedNot reported
Peak-dose dyskinesia“59”“72.8”“39.8”“34.4”“0.0404”
Diphasic dyskinesia“14”“17.3”“46.1”“35.5”“0.0127”
Off dyskinesia“10”“12.4”“49.9”“35.7”“0.0097”
Morning dystonia“27”“33.3”“40.7”“35.6”“<0.1277”
Clinical correlates and multivariable predictors of the PDQ-39 Summary Index, including levodopa dosing frequency

“A two-tailed 5% threshold of significance was retained, and only P values lying below this threshold are reported.” (opens the source at this quote in a new tab)

“The disease duration led to a significant alteration of the dimensions Mobility (r = +0.46; P < 0.0001), Activities of Daily Living (r = +0.35; P < 0.0001), Stigma (r = +0.27; P = 0.0014), Social Support (r = +0.18; P = 0.03), and Communication (r = +0.35; P < 0.0001).” (opens the source at this quote in a new tab)

“A degradation of the QL was observed with the duration of dopatherapy, in the dimensions Mobility (r = +0.53; P < 0.0001), Activities of Daily Living (r = +0.44; P < 0.0001), Emotional Well-Being (r = +0.26; P < 0.014), Stigma (r = +0.26; P < 0.013), and Communication (r = +0.41; P < 0.0001) and in the PDQ-SI (r = +0.42; P = 0.0002).” (opens the source at this quote in a new tab)

“The severity of disease (H&Y) affected the QL in the dimensions Mobility (r = +0.44; P < 0.0001), Activities of Daily Living (r = +0.49; P < 0.0001), and Communication (r = +0.29; P = 0.0005) and in the PDQ-SI (r = +0.37; P < 0.0001).” (opens the source at this quote in a new tab)

“A higher total Motor score evaluated in an on state according to Part III of the UPDRS led to a degradation of the QL in the dimensions Mobility (r = +0.24; P = 0.0054) and Activities of Daily Living (r = +0.37; P < 0.0001) and in the PDQ-SI (r = +0.24; P = 0.0092).” (opens the source at this quote in a new tab)

“A greater daily dosage of L-dopa significantly worsened the QL in the dimensions Mobility (r = +0.33; P = 0.0003), Activities of Daily Living (r = +0.31; P = 0.0007), Emotional Well-Being (r = +0.26; P = 0.0048), Stigma (r = +0.31; P = 0.0004), Social Support (r = +0.20; P = 0.027), and Communication (r = +0.28; P = 0.0019) and in the PDQ-SI (r = +0.42; P < 0.0001).” (opens the source at this quote in a new tab)

“A larger number of doses of L-dopa was likewise detrimental for the QL in the dimensions Mobility (r = +0.40; P < 0.0001), Activities of Daily Living (r = +0.30; P = 0.0008), Emotional Well-Being (r = +0.26; P = 0.0048), Stigma (r = +0.33; P = 0.0002), Social Support (r = +0.24; P = 0.01), and Communication (r = +0.24; P = 0.007) and in the PDQ-SI (r = +0.42; P < 0.0001).” (opens the source at this quote in a new tab)

“Inclusion of all factors concerning PD patients (sex and age at PD onset), disease (duration of PD at assessment, H&Y stage, and UPDRS III score), L-dopa treatment (daily dose and number of doses/day) and motor complications (occurrence or not of MF/LIDs and AIMS) in a multivariate linear model showed a contribution of 43% (part of total R-square) to the PDQ-SI.” (opens the source at this quote in a new tab)

“Among the explanatory variables, the individual contribution determined by partial R-square was 17% for the number of L-dopa doses per day, 10% for the UPDRS III score, 7% for AIMS, and less than 2% for the other variables.” (opens the source at this quote in a new tab)

“Among clinical characteristics, the number of L-dopa doses was significantly related to age at the onset of PD (r = −0.43; P < 0.0001), disease duration (r = +0.47; P < 0.0001), H&Y stage (r = +0.22; P = 0.012), L-dopa dose (r = +0.83; P < 0.0001), and AIMS (r = +0.47; P = 0.0021) but not to the UPDRS III score.” (opens the source at this quote in a new tab)

“It may only mean that there is an information overlap between MF/LIDs and the “complexity” of treatment (number of L-dopa doses), which might be the best indication of a difficult case of PD management and, thus, a poor QL in the patient.” (opens the source at this quote in a new tab)

“The levels of causality among PD characteristics are somewhat difficult to analyze, because our study did not take into account the chronological sequence of events.” (opens the source at this quote in a new tab)