Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial

Yébenes, Justo Garcı́a de; Landwehrmeyer, G. Bernhard; Squitieri, Ferdinando; Reilmann, Ralf; Rosser, Anne Elizabeth; Barker, Roger A.; Saft, Carsten; Magnet, Markus; Sword, A; Rembratt, Åsa; Tedroff, Joakim

doi:10.1016/s1474-4422(11)70233-2

Cited by 158 publications

(134 citation statements)

References 26 publications

Supporting

Mentioning

126

Contrasting

Order By: Relevance

“…In clinical trials conducted in HD patients, pridopidine at a dose of 45 mg twice daily non‐significantly improved the modified motor score (mMS) and significantly improved the total motor score (TMS) of the Unified Huntington's Disease Rating Scale (UHDRS). In both studies, pridopidine was considered safe and well tolerated with a benign adverse event (AE) profile 4, 5, 6.…”

Section: Introductionmentioning

confidence: 99%

The effect of mild and moderate renal impairment on the pharmacokinetics of pridopidine, a new drug for Huntington's disease

Rabinovich‐Guilatt

Siegler

Schultz

et al. 2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

AimPridopidine, a new oral drug for treatment of patients with motor symptoms associated with Huntington's Disease (HD) is currently under development. In steady‐state conditions, pridopidine elimination is mediated primarily through renal excretion. This study evaluated single dose and steady‐state pharmacokinetics (PK) of a daily dose of pridopidine in subjects with mild and moderate renal impairment and matched healthy subjects.MethodsSubjects with mild renal impairment (n = 12), moderate impairment (n = 12), or their matched healthy controls (n = 25) participated in this study. Subjects received a single dose of pridopidine (45 mg) on day 1 and a multiple dose cycle of 45 mg once daily on days 5–18. Blood and urine samples were collected on days 1 and 18 for PK analysis.ResultsMild renal impairment did not affect the PK of pridopidine whilst an increase in exposure was seen in subjects with moderate renal impairment. Subjects with moderate impairment showed reduced plasma clearance (by 44%) and had 68% higher AUC (90% CI 1.22, 2.30) and 26% higher C max (90% CI 1.02, 1.56) values than those with normal renal function at steady‐state. Pridopidine was safe and well tolerated in healthy subjects and in subjects with mild and moderate renal impairment.ConclusionsMild renal impairment has no impact on exposure to pridopidine while moderately impaired renal function resulted in higher pridopidine concentrations.

show abstract

Section: Introductionmentioning

confidence: 99%

The effect of mild and moderate renal impairment on the pharmacokinetics of pridopidine, a new drug for Huntington's disease

Rabinovich‐Guilatt

Siegler

Schultz

et al. 2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…20,21 Since then, 2 reports have been published on pridopidine (a dopaminergic stabilizer) that found no effect on cognitive end points, although one found a possible effect on motor end points. 22 The Cochrane reviews concluded that most trials did not meet basic requirements for meta-analysis.…”

Section: Results Of Cochrane Systematic Reviewsmentioning

confidence: 99%

Treatment of Cognitive Deficits in Genetic Disorders

et al. 2015

View full text Add to dashboard Cite

“…While blinding of interventions can minimize potential bias, clinicians are subject to expectations on the effectiveness of drugs. For example, in a recent clinical trial of pridopidine in Huntington disease, in which 2 previous trials suggested an improvement in the total motor score in the active arm [15, 16], the total motor score in both the placebo and active arms improved substantially in a disorder where scores should worsen [17]. …”

Section: Opportunity For Digital Biomarkersmentioning

confidence: 99%

The First Frontier: Digital Biomarkers for Neurodegenerative Disorders

et al. 2017

View full text Add to dashboard Cite

Current measures of neurodegenerative diseases are highly subjective and based on episodic visits. Consequently, drug development decisions rely on sparse, subjective data, which have led to the conduct of large-scale phase 3 trials of drugs that are likely not effective. Such failures are costly, deter future investment, and hinder the development of treatments. Given the lack of reliable physiological biomarkers, digital biomarkers may help to address current shortcomings. Objective, high-frequency data can guide critical decision-making in therapeutic development and allow for a more efficient evaluation of therapies of increasingly common disorders.

show abstract

Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial

Cited by 158 publications

References 26 publications

The effect of mild and moderate renal impairment on the pharmacokinetics of pridopidine, a new drug for Huntington's disease

The effect of mild and moderate renal impairment on the pharmacokinetics of pridopidine, a new drug for Huntington's disease

Treatment of Cognitive Deficits in Genetic Disorders

The First Frontier: Digital Biomarkers for Neurodegenerative Disorders

Contact Info

Product

Resources

About