A multicentre, multinational, double blind, randomised, parallel group, placebo-controlled study of ethyl-eicosapentaenoate (EPA) in patients with Huntington's disease (HD)

2013 ◽  
Author(s):  
Harald Murck
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Controlled Study ◽  
Double Blind ◽  
Parallel Group

A randomized, placebo-controlled trial of coenzyme Q10 and remacemide in Huntington’s disease

Neurology ◽  
2001 ◽  
Vol 57 (3) ◽  
pp. 397.1-404 ◽  
Author(s):  
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Controlled Trial ◽  
Coenzyme Q ◽  
Functional Decline ◽  
Double Blind ◽  
Clinical Trial Research ◽  
Parallel Group ◽  
To Receive ◽  
Primary Measure

Objectives: To determine whether chronic treatment with coenzyme Q10 or remacemide hydrochloride slows the functional decline of early Huntington’s disease (HD).Methods: The authors conducted a multicenter, parallel group, double-blind, 2 × 2 factorial, randomized clinical trial. Research participants with early HD (n = 347) were randomized to receive coenzyme Q10 300 mg twice daily, remacemide hydrochloride 200 mg three times daily, both, or neither treatment, and were evaluated every 4 to 5 months for a total of 30 months on assigned treatment. The prespecified primary measure of efficacy was the change in total functional capacity (TFC) between baseline and 30 months. Safety measures included the frequency of clinical adverse events.Results: Neither intervention significantly altered the decline in TFC. Patients treated with coenzyme Q10 showed a trend toward slowing in TFC decline (13%) over 30 months (2.40- versus 2.74-point decline, p = 0.15), as well as beneficial trends in some secondary measures. There was increased frequency of nausea, vomiting, and dizziness with remacemide and increased frequency of stomach upset with coenzyme Q10.Conclusions: Neither remacemide nor coenzyme Q10, at the dosages studied, produced significant slowing in functional decline in early HD.

IV amantadine improves chorea in Huntington's disease An acute randomized, controlled study

Neurology ◽  
2003 ◽  
Vol 60 (12) ◽  
pp. 1995-1997 ◽  
Author(s):  
C. Lucetti ◽  
P. Del Dotto ◽  
G. Gambaccini ◽  
G. Dell' Agnello ◽  
S. Bernardini ◽  
...  
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled

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

2011 ◽  
Vol 10 (12) ◽  
pp. 1049-1057 ◽  
Author(s):  
Justo Garcia de Yebenes ◽  
Bernhard Landwehrmeyer ◽  
Ferdinando Squitieri ◽  
Ralf Reilmann ◽  
Anne Rosser ◽  
...  
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Motor Function ◽  
Controlled Trial ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

Acetyl L-Carnitine Slows Decline in Younger Patients With Alzheimer's Disease: A Reanalysis of a Double-Blind, Placebo-Controlled Study Using the Trilinear Approach

1998 ◽  
Vol 10 (2) ◽  
pp. 193-203 ◽  
Author(s):  
John O. Brooks ◽  
Jerome A. Yesavage ◽  
Angelico Carta ◽  
Daniele Bravi
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Average Rate ◽  
The United States ◽  
Rate Of Change ◽  
Disease Assessment ◽  
Controlled Study ◽  
Double Blind ◽  
Parallel Group ◽  
Longitudinal Effects

Objectives: To assess the longitudinal effects of acetyl-L-carnitine (ALC) on patients diagnosed with Alzheimer's disease. Design: Longitudinal, double-blind, parallel-group, placebocontrolled. Setting: Twenty-four outpatient sites across the United States. Participants: A total of 334 subjects diagnosed with probable Alzheimer's disease by NINCDS-ADRDA criteria. These data were originally reported by Thal and colleagues (1996). Measurements: Cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS) given every 3 months for 1 year. Results: The average rate of change was estimated using the trilinear approach, which allows for periods of both change and stability. Both the ALC group and the placebo group exhibited the same mean rate of change on the ADAS (0.68 points/month). However, a multiple regression analysis revealed a statistically significant Age × Drug interaction characterized by younger subjects benefiting more from ALC treatment than older subjects. Further analyses suggested that the optimal, though not statistically significant, cutpoint for ALC benefit was 61 years of age. Conclusions: ALC slows the progression of Alzheimer's disease in younger subjects, and the use of the trilinear approach to estimate the average rate of change may prove valuable in pharmacological trials.

scholarly journals Antidopaminergic treatment is associated with reduced chorea and irritability but impaired cognition in Huntington’s disease (Enroll-HD)

2020 ◽  
Vol 91 (6) ◽  
pp. 622-630
Author(s):  
Kate L Harris ◽  
Wei-Li Kuan ◽  
Sarah L Mason ◽  
Roger A Barker
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Case Reports ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Control Group ◽  
Open Label ◽  
Double Blind ◽  
Before And After ◽  
Rate Of Decline

ObjectivesAlterations in dopamine neurotransmission underlie some of the clinical features of Huntington’s disease (HD) and as such are a target for therapeutic intervention, especially for the treatment of chorea and some behavioural problems. However, justification for such an intervention is mainly based on case reports and small open label studies and the effects these drugs have on cognition in HD remain unclear.MethodsIn this study, we used the Enroll-HD observational database to assess the effects of antidopaminergic medication on motor, psychiatric and cognitive decline, over a 3-year period. We first looked at the annual rate of decline of a group of HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466). The groups were matched on specified clinical variables using propensity score matching. Next, we studied a separate group of HD patients who were prescribed such medications part way through the study (n=90) and compared their rate of change before and after the drugs were introduced and compared this to a matched control group.ResultsWe found that HD patients taking antidopaminergic medication had a slower progression in chorea and irritability compared with those not taking such medications. However, this same group of patients also displayed significantly greater rate of decline in a range of cognitive tasks.ConclusionIn conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition. However, further research is required to prospectively investigate this and whether these are causally linked, ideally in a double-blind placebo-controlled trial.

scholarly journals Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

2019 ◽  
Vol 20 (4) ◽  
pp. 856 ◽  
Author(s):  
Rafal Kaminski ◽  
Marta Maksymowicz-Wleklik ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Agnieszka Dabrowska-Thing ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Tear ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Non Union ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant ◽  
Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

Oral laquinimod in patients with relapsing-remitting multiple sclerosis: 36-week double-blind active extension of the multi-centre, randomized, double-blind, parallel-group placebo-controlled study

2010 ◽  
Vol 16 (11) ◽  
pp. 1360-1366 ◽  
Author(s):  
G. Comi ◽  
O Abramsky ◽  
T Arbizu ◽  
A Boyko ◽  
R Gold ◽  
...  
Keyword(s):  
Liver Enzymes ◽  
Extension Phase ◽  
Controlled Study ◽  
Safety Signal ◽  
Double Blind ◽  
Clinical Assessments ◽  
Parallel Group ◽  
Relapsing Remitting ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Efficacy Profile

Background: Laquinimod, an oral novel immunomodulator, was shown to reduce MRI-measured disease activity in relapsing—remitting MS (RRMS) patients. Objectives: To determine whether the safety and efficacy profile of laquinimod, as shown in a placebo-controlled 36-week trial (LAQ/5062), is sustained and reproducible. Methods: Two hundred and fifty seven patients entered the extension phase in which MRI was performed at the beginning and at the end of the active extension phase. Clinical assessments were performed at weeks 4, 12 and every 12 weeks thereafter. Results: Two hundred and thirty nine (93%) patients completed the extension phase and 222 (86.3%) had a final scan available. Gadolinium-enhanced (GdE) T1 lesions were significantly reduced for patients switching from placebo to 0.3/ 0.6 mg doses (52%, p = 0.0006). In patients initially randomized to 0.6 mg in LAQ/5062 the reduction of MRI activity observed in the placebo-controlled phase was maintained in the extension. The proportion of GdE-free patients for those who switched from placebo increased from a baseline of 31% to 47% at the end of the extension phase ( p = 0.01). The most prominent safety signal was elevations of liver enzymes, reversible in all cases. Conclusions: The good efficacy and the excellent safety and tolerability profiles of laquinimod 0.6 mg/day are confirmed in this extension study.

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